WAND User Manual
Contents
1. Yes or No Does the product contain a medical device which incorporates a medicine as an integral part and that has an action ancillary to the device Please select Yes or No WAND User Guide Version 3 1 Page 27 of 47 Notification At the bottom of the notification the Status box will Status default to Draft Note Notifications in the Draft folder have NOT been submitted to Medsafe To submit the notification to Medsafe select Final from the drop down box Notification Status Draft gt Draft If the notification is not complete it may be saved to the Draft folder by clicking Save and Close Draft notifications may be accessed by opening the View Draft Devices folder from the left hand Menu on the homepage Once Final has been selected the declaration will become visible and the Submit button will appear WAND User Guide Version 3 1 Page 28 of 47 Making a Declaration Before submitting the notification to Medsafe the sponsor must make a declaration that the sponsor accepts the responsibilities associated with supplying a medical device in New Zealand or exporting a medical device In completing the declaration the sponsor is declaring that e the product is a medical device e the device will only be recommended by the sponsor for the purpose specified by the manufacturer and e the information included in or2. Electron beam sterilisation Ethylene oxide Filtration Gamma irradiation Gas plasma sterilisation Glutaraldehyde ha Is the device Please select Yes or No intended to be invasive Invasive medical device means a medical device that is intended by the manufacturer to be used in whole or in part to penetrate the human body through a body orifice or through the surface of the body WAND User Guide Version 3 1 Page 22 of 47 Is the device or any form of the device intended for single use Please select Yes or No Is the device an active device Please select Yes or No Active medical device a means a medical device that is intended by the manufacturer i to depend for its operation on a source of electrical energy or other source of energy other than a source of energy generated directly by a human being or gravity and ii to act by converting that energy but b does not include a medical device that is intended by the manufacturer to transmit energy a substance or any other element between a medical device to which paragraph a applies and a human being without any significant change in the energy substance or other element being transmitted Does the device contain material or ingredients of microbial origin Please select Yes or No Does the device contain material or ingredients manufactured or formulated using a
3. A WAND notification is not considered valid or current while it is in Draft mode Open the WAND notification and edit the desired fields Notice that the Notification Status at the bottom of the page is Draft Save the changes to the notification by clicking Save and Close at the bottom of the notification The notification will remain in the Draft Devices folder until the sponsor changes the status to Final and submits it to WAND When all the changes have been completed and the notification is ready to be submitted again change the Notification Status from Draft to Final at the bottom of the screen Notification Status Draft gt me Save Save and Close Cancel Once a notification has been put back to Final the declaration will appear The declaration must be made before submitting it to Medsafe see Step 4d for more information WAND User Guide Version 3 1 Page 38 of 47 If the edited notification is accepted a message confirming the new device notification will be displayed The notification should immediately appear in the Home Current WAND Notifications screen WAND User Guide Version 3 1 Page 39 of 47 Step 5e Making a current device notification Obsolete If a device is no longer being supplied by a sponsor in New Zealand it is the sponsor s responsibility to update the WAND database This is done by selecting the desired notification from the
4. Home Current WAND notifications screen and scrolling to the bottom to view the notification Status Status Obsolete To delete the WAND notification select Obsolete from the drop down menu next to the Status field Once this is done click Save at the bottom of the screen The device will now be removed from the Home Current WAND notification screen WAND User Guide Version 3 1 Page 40 of 47 Step 5f Changing the sponsor of a notified medical device A WAND device notification number is a unique identifier that specifies a particular combination of sponsor manufacturer and device It is therefore not possible to reassign a device notification from one sponsor to another if there is a change in supply arrangements in New Zealand The current sponsor Sponsor A must make the relevant device notifications obsolete and the new sponsor Sponsor B must notify the devices to the WAND database Note Regulation 8 of the Medicines Database of Medical Devices Regulations 2013 requires sponsors to update the information in the database within 10 working days of it ceasing to be either accurate or complete Sponsors are recommended to follow the procedure outlined below when a change of sponsor is required 1 One month prior Sponsor B to apply for access to the WAND database if not already a sponsor Refer Step 2 2 One month prior Sponsor B to request from the manufacturer information
5. WAND form Sections One and Two from the Medsafe website Receive a unique WAND User ID and password from Medsafe STEP 3 Confirm the Manufacturer s Details Confirm the manufacturer s details are correct in WAND If the manufacturer is not present notify details of the manufacturer for inclusion in the database STEP 4a Determine GMDN Codes Using e Information from manufacturer or e The Search function next to the STEP 4 Notifying a Medical Device GMDN field on the notification form Verify that the desired manufacturer s address is already registered with Medsafe Complete the on line Medical Device Notification form STEP 4b Determine Risk Click submit on the final draft to send the notification to Classification Medsafe Using e Information from manufacturer or e The Classification Guide that is available on the notification form STEP 4c Grouping of medical STEP 5 Maintaining the information in WAND devices Update or correct information within 10 working days of a change occurring Check whether the devices are able to be grouped together for notification to WAND WAND User Guide Version 3 1 Page 9 of 47 Step 1 Identifying Medical Devices The legal definition of a medical device in New Zealand is stated in the Medicines Act 1981 as amended by the Medicines Amendment Act 2013 The definitions for a medical device and therapeutic purpose appear in the Definitions section of th
6. action in or on the human body by pharmacological immunological or metabolic means but may be assisted in its function by such means and c also includes i anything that is intended to be used with a device instrument apparatus appliance article or material referred to in paragraph a or b to enable the device instrument apparatus appliance article or material to be used as its manufacturer intends and ii any device instrument apparatus appliance article or material of a kind or belonging to a class that is declared by regulations to be a medical device for the purposes of this Act but d does not include a device instrument apparatus appliance article or material of a kind or belonging to a class that is declared by regulations not to be a medical device for the purposes of this Act In this Act unless the context otherwise requires therapeutic purpose means any of the following purposes or a purpose in connection with any of the following purposes a preventing diagnosing monitoring alleviating treating curing or compensating for a disease ailment defect or injury or b influencing inhibiting or modifying a physiological process or c testing the susceptibility of persons to a disease or ailment or d influencing controlling or preventing conception or e testing for pregnancy or f investigating replacing or modifying parts of the human WAND User Guide Version 3 1 Page
7. full description of the GMDN term in a drop down window The GMDN codes used in the WAND database are regularly updated however if the code the manufacturer has provided does not appear in the database please contact Medsafe at devices moh govt nz for assistance Medsafe cannot assign a GMDN code as it is the role of the manufacturer to determine the nature and use of the device Specified GMDN terms For a basic Class device only a Specified GMDN descriptor may be used if an exact term is not available Specified GMDN terms can be readily identified as they include the term lt specify gt in the descriptor field i e Analyser lt specify gt WAND User Guide Version 3 1 Page 16 of 47 Step 4b Risk Classifications The WAND database system uses a rules based risk classification system to assign a risk profile for each device The rules used are detailed in Schedule 2 of the Medicines Database of Medical Devices Regulations 2003 and are based on the Global Harmonisation Task Force GHTF risk classification system There are six risk classes for medical devices plus one optional class for the notification of IVDs Class Class sterile and or measuring Increasing Class lla risk Class IIb Class Ill Class AIMD active implantable medical device IVD Optional The risk class for the device is determined by using the classification system in Schedule 2 of the Medicines Database of Medica
8. genetically modified organism Please select Yes or No Does the device contain material or ingredients of human origin Please select Yes or No Note The donation and supply of products containing human cells may be subject to the requirements of the Human Tissue Act 2008 Human tissue products require the approval of the Minister of Health before they may be legally supplied in New Zealand Does the device contain human blood or its components Please select Yes or No WAND User Guide Version 3 1 Page 23 of 47 Does the device Please select one of the following descriptors from the consist of drop down menu e Procedure Pack e Single product e System Does the device consist of lt Select gt lt Select gt Procedure pack Single product System A Procedure Pack is a group of components which include medical device s and is intended to be used for a specific purpose The pack itself must be notified and the components listed in the notification If these are also supplied separately the medical device components must also be notified individually to WAND A Single Product is a device that is supplied on its own A System is a group of devices intended to be used together A single notification can encompass the entire system unless the individual components are also supplied separately in which case individual notification of the c
9. if the device is a kit procedure pack or multi component system please ensure this is indicated and do not identify the product as a single device e if the device is active powered by an energy source other than human effort or gravity please ensure it is identified as such e if the device contains components please list each of the components in the appropriate field e if the device is medicated or formulated made by mixing a series of known ingredients in specific proportions please identify this and include details of medication or formulation Please advise Medsafe if this information is confidential Note The draft notification may be saved at any point during the notification process This allows the draft notification to be worked on at a later time without having to re enter information Draft notifications are not lodged to the WAND database and may be identified as the central four characters of the identifier are DAFT i e 123456 DRFT QW3RT6 In a completed notification the central four characters of the identifier are WAND i e 123456 WAND QW3RAT6 Draft WAND User Guide Version 3 1 Page 20 of 47 notifications are stored in the Draft Notifications folder which may be accessed from the Menu on the left hand side of the screen Intended Purpose purpose of the device Manufacturer ARTG ID if known Sponsor s own Reference xi Class gt Select gt FA GMDN Manufacturers intended use
10. of the list of WAND notifications and use your mouse to select all the WAND information on the screen With all the information selected click on Edit in the toolbar in your browser and then click on Copy 7 Move to your spread sheet program 8 Click in an empty cell then click on Home or Edit depending on your 10 11 12 13 14 15 16 program in the toolbar in your spreadsheet program and then click on Paste The information from WAND should now appear in the spreadsheet Save the spreadsheet If you have more than one screen of WAND notifications move back to WAND scroll to the bottom of the screen and click on the next page number to display additional notifications Repeat steps 5 through 11 until all the WAND notifications have been copied to the spreadsheet Once all the WAND notifications have been copied click on the column header of the column containing all of the WAND numbers This should highlight the contents of that column Right click the mouse anywhere in the highlighted column and select Remove hyperlink All of the WAND numbers should now change colour to black and no longer be underlined Save the spreadsheet The creation of the spreadsheet is now completed You are now able to sort and filter the data as required WAND User Guide Version 3 1 Page 45 of 47 Medical Device Recall Contacts Directory In the event that a sponsor needs to cond
11. processes for suppliers of devices including updates on Updates on safety medicines and medical staying safe and healthy information and how to report problems devices News and Events want to 6 June 2014 Publications Prescriber Update Vol 35 2 June 2014 28 May 2014 Policy Statement Changes to the Definition of Medicines and login to the medical device il Medical Devices Effective 1 July 2014 database WAND 27 May 2014 Safety New sedfi r Dear Healihears Professional x TE sa Letters aiis ices m find consumer medicine information 23 May 2014 Media Release Dangers of purchasing medicines over the internet l highlighted Operation PANGEA VII Enter the WAND User Name 5 digit Sponsor ID number and password Click Log In Login Sponsor Identification WAND User Name Password Forgot Your Password Enter your WAND User Name to receive your password WAND User Name Note If password has been lost or forgotten the password may be reset by typing the WAND User Name Sponsor ID into the Forgot Your Password box The new password will automatically be sent to the sponsor s WAND Administrator s email address WAND User Guide Version 3 1 Page 12 of 47 If the sponsor has lost their Sponsor ID contact Medsafe for assistance at devices moh govt nz Verify the Sponsor Details Once logged into WAND t
12. the WAND database are not required to have the ingredients entered into the database as IVDs do not come into direct contact with the patient If Yes is selected for either the following Ingredients box will appear on the notification Is the device medicated Yes CNo Is the device formulated C Yes CNo Ingredients EZB Iselect___ ingredient__ Qtyfrom _ Unit__ tyto unit _ Click the Add button in the Ingredients box and the following Search box will appear WAND User Guide Version 3 1 Page 26 of 47 Add Ingredient Search for name containing purified water Ingredient Name Preferred Name Purified water Purified water Quantity from Unit lt Select gt gt Quantity to Unit jS Purified water Ingredient pg cm yg dose Type the name of the ingredient in the Search box and click Search A list of both Ingredient Names and Preferred Synonym Names will appear From either list choose the correct ingredient for the device Enter the quantity and the unit of the ingredient selected For example 0 5 Purified Water If the device contains exactly 5 Water please enter the values as 5 5 Water Note If the desired ingredient cannot be located please contact Medsafe at devices moh govt nz for assistance Does the product contain a medicine that has consent for marketing in New Zealand Please select
13. the device notification to be printed This will display the full notification Scroll to the bottom of the screen Return to Draft Copy Device Less Details Printer Friendly To print the full notification click on the Printer Friendly button to display the notification as it will appear when printed To print the notification use the browser print button Click on the Less Details button to display the notification with a reduced level of detail This will reduce the fields displayed to show sponsor name WAND reference sponsor s reference and the GMDN term To print the reduced details notification click on Printer Friendly then print using the browser print button WAND User Guide Version 3 1 Page 44 of 47 d Generating a spreadsheet of device notifications There is no option within WAND for a sponsor to automatically generate a spreadsheet of the device notifications they have notified However it is possible to build such a spreadsheet from the table of active notifications displayed on the Home Current WAND notifications screen To do this follow the instructions below 1 2 Open your spreadsheet program and open a new spreadsheet Log into the WAND database using the 5 digit Sponsor ID Number User Name and password Confirm your sponsor details are correct 4 The list of current submitted device notifications is displayed on the screen Move to the bottom right hand cell
14. 4 of 47 anatomy Sponsor In relation to a medical device a means i a person in New Zealand who exports or arranges the exportation of the device from New Zealand ii a person in New Zealand who imports or arranges the importation of the device into New Zealand iili a person in New Zealand who manufactures the device in New Zealand or arranges for another person to manufacture the device in New Zealand for supply whether in New Zealand or elsewhere but b does not include a person who i exports imports or manufactures a device or ii arranges for the exportation importation or manufacture of a device on behalf of another person who at the time of the exportation importation manufacture or making of the arrangements is a resident of or is carrying on business in New Zealand WAND User Guide Version 3 1 Page 5 of 47 Introduction This document is a guide for sponsors of medical devices in meeting the regulatory requirements under the Medicines Database of Medical Devices Regulations 2003 Contained within this document are instructions for WAND processes and explanations of some of the features available within the database Background The Medicines Database of Medical Devices Regulations 2003 came into force on 1 January 2004 The regulations require a sponsor being an individual or organisation that manufactures imports or exports a medical device into or from New Zealand to notify details of t
15. 47 Step 4f Troubleshooting medical device notifications If the confirmation screen message Step 4d page 28 does not appear it means that the notification has not been accepted into WAND The draft notification will remain on the screen The reasons why the notification could not be successfully lodged with the database will be displayed in red at the top of the screen Errors or Omissions If a field has been left blank the error message will request the error be fixed Web Assisted Notification of Devices Add a New Device Please fix the following error s Class is required Mandatory Review the errors listed check the information entered as part of the notification and correct the information as appropriate If the errors cannot be resolved save the notification as a draft notification so it may continue to be worked on later Draft notifications are stored in the Draft Notifications folder which may be accessed from the Menu on the left hand side of the screen GMDN Code To ensure that medicines and products that are not medical devices are not notified to the WAND database Medsafe filters products based on the GMDN code entered Based on selected GMDN codes products that do not meet the definition of a medical device will not be able to be notified to WAND Notifications of these products will receive an error message like the following Web Assisted Notification of Devices Add a New De
16. A list of registered manufacturers matching the search term will appear Select the manufacturer of the device from this list ARTG if known This is an optional field If the device has been included on the ARTG please insert the ARTG number in this field Otherwise leave it blank In the second half of the WAND Notification specific details about the device will be requested such as whether the device is supplied sterile whether the device is active powered whether the device is for single or multiple use if it has materials of biological origin and whether it is a single device or system or procedure pack Additionally if the medical device includes a medicine is formulated or is made up of several components as a system or procedure pack this should be indicated If the product is indicated as being medicated or formulated the sponsor will be required to enter additional information identifying the medication or detailing the formulation If this information is confidential to the manufacturer please contact Medsafe for advice If the device is indicated to be a system or procedure pack the sponsor will be required to identify the independent components Is the device or If Yes please select the appropriate sterilisation any form of the method from the drop down menu device supplied steri le Is the device or any form of the device supplied sterile Yes CNo Sterilisation method lt Select gt gt
17. GMDN Codes The Global Medical Device Nomenclature GMDN code is a coding system intended to provide universally understood descriptions of medical devices The coding system is administered by the GMDN Agency Information about the GMDN Agency is available on its website at www gmdnagency org The GMDN code is a 5 digit code that references a definition of a device The GMDN code for the device is determined by the manufacturer If the device is marketed in Europe Canada or Australia the manufacturer should already have determined the GMDN code for the device The WAND system includes a GMDN Search tool to assist in locating codes Once logged into the WAND system enter one or more words describing the device into the GMDN box then click the Search button The search will look for the word at the beginning of each term name To search the entire GMDN descriptor for the words entered use the wildcard at the end of the word For example o typing bandage in the Search box the database will provide a list of all GMDN terms that contain the word bandage anywhere in the descriptor o typing jbandage in the Search box the database will only provide a list of all GMDN terms that start with the word bandage e A second box will appear with a list of possible GMDN descriptors e Scroll down the list and select an appropriate term e Check if this is appropriate by clicking the yellow which gives a
18. MEDSNFE NEW ZEALAND WEDIcINES A 280 c vevc SAFETY AUTHORITY A BUSINESS UNIT OF ERISTA OF HEALTH User Guide for WAND Web Assisted Notification of Devices Version 3 1 July 2014 MINISTRY OF New Zealand Government HEALTH MANATU HAUORA Document History Revision Date Version Summary of changes Number 2003 1 Release of WAND manual 1 Feb 2010 2 Update of WAND manual to cover operation of new version of WAND 1 Jul 2014 3 Revision of WAND manual to reflect changes to definition of medicine medical device and therapeutic purpose in the Medicines Amendment Act 2003 Updated instructions for the use of the WAND database 14 Jul 2014 3 1 Instructions added relating to material of animal origin in IVDs and to formulated devices WAND User Guide Version 3 1 Page 2 of 47 Contents DIG TATIONS ai E A E E E E E E E EEE EEE 4 INTFOGDUGTION me EEEE TETTE 6 BaCkQround AAA A A 6 Internet Browser Compatibility ccccsseeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeseeeeeeeeeeeeeeeeeeeeeees 7 The WAND Process oo cdccccccnccancsdnevancvanch seve acvecevenckcevsacveccdenceeacdesdvasedesdeancdeideanedeneveces 8 Key Steps in the WAND Process eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeneees 9 Step 1 Identifying Medical DeViCes ccs seeeeeeeeeeeeeeeeeeseeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 10 Step 2 Obtain Access to WAND eeeeeeeeeeeee
19. Other Features icecccseenseastcuesewatouaneus SensmeuataveweacSoueneudtaueneudaweneweSaweneweSaussewSaweneweSawsneus 42 a Viewing Sorting Current WAND Notifications cceeeeeeeeeeeeteeeeeeees 42 b Searching For a Specific Device in Current Notifications 0 43 c Printing a device notification fatcacatincidircatiivatshindtiiadtiiadtiice 44 d Generating a spreadsheet of device notifications sseeeeeeeeeee 45 Medical Device Recall Contacts Directory ccccccsssssseeeeeeeeeeeeeeeeeneeeeeeeeeeeeeeeeees 46 WAND User Guide Version 3 1 Page 3 of 47 Definitions The following definitions are from the Medicines Act 1981 incorporating changes made by the Medicines Amendment Act 2013 the Act and the Medicines Database of Medical Devices Regulations 2003 the Regulations Medical Device Therapeutic Purpose In this Act unless the context otherwise requires medical device a means any device instrument apparatus appliance or other article that i is intended to be used in on or for human beings for a therapeutic purpose and ii does not achieve its principal intended action in or on the human body by pharmacological immunological or metabolic means but may be assisted in its function by such means and b includes a material that i is intended to be used in or on human beings for a therapeutic purpose and ii does not achieve its principal intended
20. about the intended purpose and GMDN codes in preparation for making the new device notification 3 On the date of the change Sponsor B to begin notifying the transferred device s to the WAND database Note that this step may commence earlier if the sponsor wishes Refer Step 4d 4 Within 10 days of the change Sponsor A to make obsolete all of the affected notifications to the WAND database Refer Step 5e 5 Within 30 days of the change Sponsor B to complete notifying the transferred device s to the WAND database 6 Optional Sponsors A and B to advise their customers of the change in WAND numbers for the transferred devices WAND User Guide Version 3 1 Page 41 of 47 Other Features a Viewing Sorting Current WAND Notifications To assist sponsors it is possible to sort device notifications by clicking on the header row above the table of notifications WAND Reference Sponsors Reference GMDN Manufacturer Sort options include e WAND Reference This will sort WAND notifications by the date The first six digits of any WAND Reference number represents the date that the notification was initially submitted to Medsafe For example a notification containing the WAND reference number 070331 WAND 72Y5CX was submitted to Medsafe on 31 03 2007 e Sponsor s Reference This will sort WAND notifications in alphabetical order based on the sponsor s reference to the device e GMDN This will sort WAND notificati
21. e been entered click on the Submit button to send the details to Medsafe for processing It can take up to 5 business days to verify this information Once the verification has been completed the new manufacturer will appears in the database and may be used for device notifications WAND User Guide Version 3 1 Page 14 of 47 Step 4 Notifying a Medical Device To successfully notify a medical device to the WAND database the information about the device must be correctly entered Please review the information in the following sections to become familiar with the WAND notification process Some of the information may need to be supplied by the manufacturer of the device This information includes The name and address of the device The GMDN code for the device The manufacturer s intended purpose for the device The method of sterilisation Whether the device contains any material of microbiological genetically modified or human origin If the device contains any material of animal origin the species and country of origin The ingredients for any formulated or medicated device This step describing the notifying of a medical device has been divided into 6 sub steps for clarity The sub steps are GMDN codes Risk classification Grouping medical devices Create a medical device notification Copying a medical device notification Troubleshooting medical device notifications WAND User Guide Version 3 1 Page 15 of 47 Step 4a
22. edical Devices Regulations 2003 states as follows e if a particular sponsor is the sponsor of 2 or more medical devices it is only necessary to enter information in respect of each kind of device instead of in respect of each device for which the sponsor is responsible if each of the devices of the same kind a was made by the same manufacturer and b has the same GMDNS code and c has the same risk classification and d is a Class I Class lla or Class Ilb medical device Regulation 5 5 defines the same kind of medical devices as being e 2ormore medical devices are of the same kind if those devices are a substantially similar to one another and b designed to be used in the same way and for the same purpose These two Regulations specify the criteria that determine whether multiple medical devices may be notified as a single record to the WAND database When considering making a notification for more than 1 medical device the sponsor should check the following criteria for all of the devices e Are these devices designed to be used the same way e Are these devices intended to be used for the same purpose e Are these devices from the same manufacturer e Do these devices have the same GMDN code e Do all of these devices have the same risk classification e ls the risk classification Class lla or IIb If the answer to all of the above questions is yes then the devices may be grouped into a single notifica
23. eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 11 Step 3 Confirm the Manufacturer s Details ssseccssessseeeseeeseeeeseeesseesseeens 12 Step 4 Notifying a Medical Device cccsseeeeeeeeeeeeeeeeeeeeeeneeeeeeeeeeeeeeeeeeeeeeeeeees 15 Stepa GMUN COES p E aa ties 16 Step 4b Risk Classifications cccccccccccccccccccceceeeeeeececeeeeeeeeeeeeeeeeeeeeeeeeeeeeeess 17 Step 4c Grouping medical AeVICES ccceeceeeeeeeeeeeeeeeeneeeeeeeeeeeeeeeennneeeeeeeees 18 Step 4d Create a Medical Device Notification ccccccccccccececceeeeeeeeeeeeeeeees 19 Step 4e Copying a medical device notification cccccccccccecceeceeeeeeeeeeeeeeeees 31 Step 4f Troubleshooting medical device notifications ccccccccceeeeeeeeeeeees 32 Step 5 Maintaining the Information in WAND sseeeeeeeeeeeeeeeeeeeees 34 Step 5a Updating the Sponsor s WAND Administrator cccceeeeeeeeeeeeees 35 Step 5b Updating the Sponsor s details c cccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 36 Step 5c Updating manufacturer information cccccccccccceccceceeeeeeeeeeeeeeeeeeees 37 Step 5d Editing a device notification cccccccccccccccccccceceeeeeeeeeeeeeeeeeeeeeeeeeeeees 38 Step 5e Making a current device notification Obsolete ccccccceesseeeeeeees 40 Step 5f Changing the sponsor of a notified medical device ccccceeeees 41
24. efinitions section of this guide Please review the definition To obtain access to the WAND database download the application form from the Medsafe website at http www medsafe govt nz requlatory DevicesNew 3 4AccessingWANDDatabase asp Complete both sections of the New Zealand WAND Application Access form Section 1 is for the sponsor details and Section 2 for the WAND Administrator who is the point of contact at the sponsor When completed submit the form to Medsafe by following the instructions on the form Forms that are incomplete incorrect or illegible will be returned without access being granted Processing a sponsor application can take up to 10 working days Once the application has been accepted and processed Medsafe will send a unique Sponsor ID number and password to the email address detailed in Section 2 of the completed form The Sponsor ID is a five digit number and will be the sponsor s WAND User Name Medsafe issues only one 1 Sponsor ID and password per sponsor If a sponsor has multiple individuals that access WAND it is the sponsor s responsibility to ensure only those that require access to the WAND database are able to use the Sponsor ID and password The password can be reset at any time with the new password being sent to the email address of the sponsor s WAND Administrator This password should be kept secure WAND is a secure database The User ID is required to ensure secu
25. he medical devices to a database within 30 days of the device being placed on the market or exported This database is called the Web Assisted Notification of Devices WAND database Sponsors are required to maintain the information notified to the WAND database Should the information entered into the WAND database cease to be correct or complete sponsors are required to correct or update the information within 10 working days of it ceasing to be correct or complete The purpose of the WAND database is to provide information for the Director General of Health to assist with the investigation of post market medical device issues and concerns by identifying the organisations supplying particular medical devices in New Zealand or exporting medical devices from New Zealand The WAND database is not an approval system Notification of a medical device to the WAND database does not constitute an approval or endorsement of the device by the New Zealand Ministry of Health There are no fees associated with notifying medical devices to the WAND database There is no public access to the information entered into the WAND database WAND is a notification database only and is reliant on information provided by sponsors about their products Inclusion of a notification on WAND does NOT indicate approval or any other endorsement of the device by the Ministry of Health Statements to that affect are prohibited under Regulation 10 of the Med
26. he need for the change i e moved location change of name acquisition by another organisation etc Medsafe will verify the information and process the request within 5 working days Note Changes to the manufacturer s details will be reflected in all notifications made for that manufacturer s products notified to WAND WAND User Guide Version 3 1 Page 37 of 47 Step 5d Editing a device notification A sponsor may edit any current device notification made to the WAND database Before editing any device notification the sponsor should be clear about the information that needs to be changed Any changes should be confirmed with the manufacturer before the notification is edited The sponsor begins the process by changing the status of an active notification from Active to Draft To do this select the WAND notification to be edited from the Home Current WAND notifications screen located in the Menu on the left hand side of the homepage Open up the notification and scroll down to the bottom Underneath the Status there are several options To edit the notification click the Return to Draft button Status Active Return to Draft Copy Device This moves the notification to the Draft Devices folder To change to this folder click on the View Draft Devices folder located in the Menu on the left hand side of the homepage The WAND notification should now be in this folder Note
27. he period specified in the regulations and g an appropriate conformity assessment procedure has been applied to devices of that kind and h i have available sufficient information to substantiate that compliance with the essential principles or ii have procedures in place to ensure that such information can be obtained from the manufacturer within the period specified in the regulations and I declare this application meets the criteria specified above in Part 2 optional of the declaration Yes No If the notification has been successfully lodged with WAND the following message will be displayed WAND User Guide Version 3 1 Page 29 of 47 Web Assisted Notification of Devices Confirmation of New Device Notification Thank you for submitting your Medical Device Notification to Medsafe The details of the notification have been emailed to Medsafe and saved in the database You can now view this notification in Current WAND Notifications Close Once submitted active WAND Notification immediately appear on the Home Current WAND Notification screen A link to this screen is located on the Menu on the left hand side of the screen When a device notification is successfully lodged with WAND the reference for it changes from 123456 DRFT QW3RT6 to 123456 WAND QW3RT6 WAND User Guide Version 3 1 Page 30 of 47 Step 4e Copying a medical device notification Sometimes it may be necessar
28. he sponsor must verify the sponsor details Once these details have been verified the sponsor will then be able to access the WAND database Sponsor s Name lt Medsafe Address P PO Box 5013 Wellington NEW ZEALAND Email gt John_Smith fake com Are these details correct r Yes No By clicking Yes the sponsor confirms the contact details displayed are correct If the details require updating please click No This will direct the user to the forms to be downloaded to make the necessary changes Download the form complete it and forward it to Medsafe for processing Web Assisted Notification of Devices Sponsor Details Update Form Sponsor Name Address Country New Zealand WAND Administrator Details Contact Persor Position Phone Emai Note The WAND Administrator is the person nominated by the sponsor as the point of contact for Medsafe concerning WAND notifications If a password is reset by a User the new password will automatically be sent to the email address of the WAND Administrator detailed above Sponsors should update the WAND Administrator details as soon as there is any change within the organisation Failure to do so may result in loss of User Access to WAND for the sponsor For changes to the sponsor s name or address please complete the Sponsor Details Update Form that is available on the Medsafe website at the link below http www medsafe govt nz requlatory De
29. ices moh govt nz or fax 04 81 9 6806 for processing WAND User Guide Version 3 1 Page 35 of 47 Step 5b Updating the Sponsor s details Changes to the details of the sponsor i e name of sponsor address contact information etc should be immediately advised to Medsafe To update the sponsor s details please download the Sponsor Details Update Form from the Medsafe website at the link below http www medsafe govt nz regulatory DevicesNew SponsorDetailsUpdateForm doc Completed forms should be sent to Medsafe by email devices moh govt nz or fax 04 81 9 6806 for processing WAND User Guide Version 3 1 Page 36 of 47 Step 5c Updating manufacturer information If the manufacturing site for a device changes and the new manufacturing site is already detailed in the WAND database the device notification should be edited as outlined in section d below If the manufacturer moves location to a new address or has a name change the manufacturer information in the WAND database needs to be updated Sponsors are not able to edit manufacturer information Sponsors should contact Medsafe to request the manufacturer s information be updated To request a change to the manufacturer s information the sponsor should email the following to Medsafe device moh govt nz e The name and details of the manufacturer as currently recorded in WAND e The details of the manufacturer needs to be changed to e An explanation of t
30. icines Database of Medical Devices Regulations 2003 WAND User Guide Version 3 1 Page 6 of 47 Internet Browser Compatibility The WAND database has only been tested for compatibility with Microsoft Internet Explorer IE software Use of other internet browsers may lead to problems entering information into the database Should there be any issues with the electronic forms please check the browser software first If the browser is not IE save the notification log out of WAND open IE and log into WAND If the problems continue please contact Medsafe at devices moh govt nz WAND User Guide Version 3 1 Page 7 of 47 The WAND Process There are five key steps in the WAND process T 2 3 4 5 Determining whether a product is a medical device Requesting access to the WAND database Notifying details of the manufacturer to the WAND database Notifying details of the medical devices to the WAND database Maintaining the information notified to the WAND database Each of these steps is explained in the following sections WAND User Guide Version 3 1 Page 8 of 47 Key Steps in the WAND Process STEP 1 Identify Notifiable Medical Devices Is the product intended to be supplied a medical device as No No a defined by the Medicines Act and not exempted by Schedule q 1 to the Medicines Database of Medical Devices Regulations 2003 Yes STEP 2 Obtain Access to WAND Submit the Access Rights to
31. is guide All medical devices are required to be notified unless specifically exempted under Schedule 1 of the Medicines Database of Medical Devices Regulations 2003 Medical devices that are currently exempted from notification are e products made specifically in accordance with a request by a registered health professional and intended to be used only in relation to a particular individual e imported devices held in bond for export e medical devices imported as part of a clinical trial e items imported for personal use and not for resale or use on others The Director General of Health may also exempt other specified medical devices or types of medical device by notice in the New Zealand Gazette Notices of Exemptions are also published to the Medsafe website Currently the only type of medical devices exempted by the Director General of Health are In Vitro Diagnostic IVD devices If in doubt please contact Medsafe at devices moh govt nz for advice Please include details of the product e g instructions for use and any examples of regulatory approval granted for the product WAND User Guide Version 3 1 Page 10 of 47 Step 2 Obtain Access to WAND Access to the WAND database is necessary for sponsors to notify details of their medical devices to the database in accordance with regulatory requirements The definition of a sponsor is stated in the Medicines Database of Medical Devices Regulations 2003 and appears in the D
32. king Yes the sponsor confirms the contact details displayed are correct If the details require updating please click No This will direct the user to the forms to be downloaded to make the necessary changes Download the form complete it and forward it to Medsafe for processing WAND User Guide Version 3 1 Page 19 of 47 Web Assisted Notification of Devices Sponsor Details Update Form New Zealand WAND Administrator Details Contact Persor Position Phone Emai Note The WAND Administrator is the person nominated by the sponsor as the point of contact for Medsafe concerning WAND notifications If a password is reset by a User the new password will automatically be sent to the email address of the WAND Administrator detailed above Sponsors should update the WAND Administrator details as soon as there is any change within the organisation Failure to do so may result in loss of User Access to WAND for the sponsor For changes to the sponsor s name or address please complete the Sponsor Details Update Form that is available on the Medsafe website at the link below http www medsafe govt nz regulatory DevicesNew SponsorDetailsUpdateForm doc Notification of a medical device to the WAND database is straightforward with a series of drop down menus to be completed However please pay particular attention to the following e if the device is intended to be supplied in a sterile state please indicate this e
33. l Devices Regulations 2003 which is available online at http www legislation govt nz regulation public 2003 0325 latest DLM224296 html To determine the correct risk classification use a process of elimination by working through the 22 rules commencing at Rule 22 Medical devices that are mammary implants and work backwards to Rule 2 By commencing at Rule 22 and working backwards higher risk devices will be readily identified enabling the correct classification to be easily determined Devices that are not eliminated by any rule are determined to be Class I If the risk classification is unable to be determined refer to the manufacturer of the device The WAND database also includes a guide on the notification form which assesses the risk class based on responses to a sequence of questions about the intended purpose of the device An IVD Class has been included on the WAND Classification drop down menu Medsafe encourages Industry to voluntarily notify IVDs to the WAND database However it is not a mandatory requirement at this time WAND User Guide Version 3 1 Page 17 of 47 Step 4c Grouping medical devices Low risk medical devices of the same type and manufactured by the same manufacturer may be grouped together in one WAND notification By using a simple checklist sponsors can determine if products may be grouped into a single notification Regulation 5 3 of the Medicines Database of M
34. n or ingredient is sourced from multiple countries a separate notification should be made for each country of origin that the material or ingredient may be sourced from In Vitro Diagnostic IVD devices being notified to the WAND database are not required to have information about material of animal origin entered into the database as IVDs do not come into direct contact with the patient Is the device medicated Is the device formulated Please select Yes or No for each of these questions A Medicated device is one in which a medicine is included in or with the device If the product contains a medicine it will need to be submitted to Medsafe for categorisation Please contact devices moh govt nz for further information WAND User Guide Version 3 1 Page 25 of 47 Note If the medicine does not have the consent of the Director General of Health or if the intended purpose of the combination is primarily medicinal then the product is likely to be considered a medicine and requires consent before it may be legally supplied Contact Medsafe for advice if uncertain A Formulated device is one in which the device is formed by mixing specific components none of which are medicines in defined proportions Examples include fillers lubricants and adhesives Ingredients purely for colour flavour or perfume need not be notified to the database In Vitro Diagnostic IVD devices being notified to
35. omponents is also required If the device includes components different models or variants please click the Add button in the Components box if your device contains any components please use the following box to include them in this notification select_type Name ___ When adding Components to the notification first select the Type Component Model or Variant Once this is done please type the name and a brief description of each component and click OK Add Component WAND User Guide Version 3 1 Page 24 of 47 Note for New Zealand manufacturers only If the manufacturer intends to request a Regulatory Statement for Foreign Governments to export the devices the individual products must be notified to the WAND database as components Does the device contain any material or ingredients of animal origin If Yes please use the drop down list to select the Species from which the material or ingredient is derived Species lt Select gt z Arthropod Beaver Bee Biotechnology Bird Bovine Canine Chicken Coelenterate Crustacean bd Next select the Country of Origin from the drop down menu Species lt Select gt bd Country of Origin lt Select gt x ARGENTINA AUSTRALIA AUSTRIA BAHAMAS BANGLADESH BELGIUM BRAZIL BRUNEI BULGARIA CANADA Note If the material of animal origi
36. ons by GMDN term e Manufacturer This will sort WAND notifications by manufacturer of the device Note After a WAND notification has been accessed and closed the screen will automatically return to the original sorting order WAND User Guide Version 3 1 Page 42 of 47 b Searching For a Specific Device in Current Notifications Sponsors may search for a specific WAND notification made by their organisation by clicking on Device Search from the menu on the left hand side of the screen The Device Search box will appear Device Search Sponsor ID _ WAND Reference GMDN FT Sponsor s own reference Manufacturer To locate the desired WAND notification enter a search term in one or more of the fields displayed Click Search and the notifications meeting the search criteria will be displayed WAND User Guide Version 3 1 Page 43 of 47 c Printing a device notification A sponsor may be asked to provide evidence that a medical device has been notified to the WAND database There is no WAND Certificate that Medsafe provides to confirm a device is notified to WAND but sponsors may print a copy of the notification to provide to a third party Recognising that some information detailed in a device notification may be considered to be commercially sensitive soonsors have the option of printing either a full printout or a reduced details printout To print a device notification begin by opening
37. rity when notifying new products If the sponsor loses the Sponsor ID do not re apply for WAND Access instead contact devices moh govt nz WAND User Guide Version 3 1 Page 11 of 47 Step 3 Confirm the Manufacturer s Details To log into the WAND database go to the Medsafe website at www medsafe govt nz and click on either the Login to WAND link from the Devices tab in the header of the website or click on the Login to the medical device database WAND option in the I want to box on the right hand side of the page indicated below lt GE http wme D BOX i File Edit View Favorites Tools Help MEDSAFG NEW ZEALAND MEDICINES Comes AND MEDICAL DEVICES SAFETY AUTHORITY G Medsafe Home Page X A BUSINESS UNIT OF THE MINISTRY OF HEALTH Dietary Supplements e Welcome to Login to WAND Home Safety Compliance Publications Consultations Committees About Medsafe Medsafe is the New Zeal Education and iniommation es Safety Authority We are responsible for the regulation of medicines and medical devices in New Zealand We nsu ces are acceptably safe l Safety For Consumers palthcare 44 For Industry Regulatory Guidance i Information that everyo H psionals F Guidance on the New should know about a Information about medicines gt Zealand regulatory medicines and medical and medical devices a
38. s the case requires This means any change to information about the sponsor a manufacturer or a device that the sponsor is aware of must be updated within 10 working days of the information ceasing to be correct or complete Guidance is provided below for the following situations Updating the sponsor s WAND Administrator Updating the sponsor s details Updating manufacturer information Editing a device notification Making a current device notification Obsolete f Changing the sponsor of a notified medical device WAND User Guide Version 3 1 Page 34 of 47 Step 5a Updating the Sponsor s WAND Administrator The sponsor s WAND Administrator is Medsafe s point of contact with the sponsor If there is a change in the WAND Administrator there is the potential Medsafe will not be able to immediately contact the sponsor should this be necessary It is therefore important that the sponsor ensure that when there is a change to the WAND Administrator the details of this contact person are immediately updated The details should also be updated in the event of a change in email address telephone number or fax number To update the sponsor s WAND Administrator s details please download the WAND Administrator Details Update Form from the Medsafe website at the link below http www medsafe govt nz requlatory DevicesNew NZWANDAaministratorDetailsU pdateForm doc Completed forms should be sent to Medsafe by email dev
39. therapeutic e Ea m e Sponsor s Own Reference This free text field is for the sponsor to use as a reference Medsafe recommends this field incorporate a description of the device that includes the brand and description to easily identify the device s notified For example Tonka Large Scale Trucks instead of Trucks Note that some words should not be used in the Sponsor s Own Reference as it may interfere with the notification process Words to avoid using include class GMDN manufacturer ARTG and purpose Class Please select the device classification from the drop down menu If required use the for classification guidance Refer to Step 4b of this guide for more information GMDN code Please choose the GMDN code specified by the device manufacturer Click the to read the full definition of the GMDN code Note See Step 4a of this guide for more information Intended Purpose Please state the purpose s that the device manufacturer intends the device to be used for This field is where the sponsor must clarify the manufacturer s therapeutic purpose of the device as defined by Section 4 of the Medicines Act 1981 Note The intended purpose is defined by the device manufacturer not the local sponsor WAND User Guide Version 3 1 Page 21 of 47 Manufacturer Enter the name of the desired manufacturer and click Search
40. tion If the answer to any question is no then the sponsor may be able to exclude 1 or more devices to create a grouped notification Alternatively the devices may have to be notified individually Note Notifications for Class III or AIMD devices cannot be grouped as these devices must include a unique product name functional description and specific details about the device WAND User Guide Version 3 1 Page 18 of 47 Step 4d Create a Medical Device Notification Enter the WAND User Name 5 digit Sponsor ID number and password Click Log In Login Sponsor Identification WAND User Name Password Forgot Your Password Enter your WAND User Name to receive your password WAND User Name Note If password has been lost or forgotten the password may be reset by typing the WAND User Name Sponsor ID into the Forgot Your Password box The new password will automatically be sent to the sponsor s WAND Administrator s email address If the sponsor has lost their Sponsor ID contact Medsafe for assistance at devices moh govt nz Verify the Sponsor Details Once logged into WAND the sponsor must verify the sponsor details Once these details have been verified the sponsor will then be able to access the WAND database Sponsor s Name Medsafe Address PO Box 5013 Wellington NEW ZEALAND Email gt John_Smith fake com Are these details correct C yes C No By clic
41. uct a recall action this should be done in compliance with the guidance printed in the Medsafe Uniform Recall Procedure for Medicines and Medical Devices This publication and further information about conducting recall action is available on the Medsafe website at the link below http www medsafe govt nz requlatory DevicesNew 8Recalls asp When communicating a recall action to users Medsafe recommends that sponsors direct their correspondence to the contacts detailed in the Medical Device Recall Contacts Directory The directory is downloaded from within the WAND website by clicking on the Hospital Recall Contacts entry located on the Menu on the left hand side of the homepage Information contained within the Directory is updated as contacts change so should only be downloaded at the time it is required Note The Directory should only be used following consultation with Medsafe regarding the conduct of a medical device recall action For further information about the Medical Device Recall Contacts Directory or about conducting a corrective action please contact recalls moh govt nz WAND User Guide Version 3 1 Page 46 of 47 WAND User Guide Version 3 1 Page 47 of 47
42. vice Please fix the following error s The GMDN indicates this product is either a Medicine or not a medical device Mandatory WAND User Guide Version 3 1 Page 32 of 47 Save the notification as a draft notification and contact Medsafe to discuss the product that is attempted to be notified to determine if the product is a medical device in New Zealand Draft notifications are stored in the Draft Notifications folder which may be accessed from the Menu on the left hand side of the screen WAND User Guide Version 3 1 Page 33 of 47 Step 5 Maintaining the Information in WAND Sponsors are required to keep the information entered into the WAND database correct and complete Regulation 8 of the Medicines Database of Medical Devices Regulations 2003 states that 1 Subclause 2 applies if any information recorded on the database in respect of a medical device or kind of medical device ceases to be accurate or complete whether because of a change of circumstances for example a change in the name of a manufacturer or sponsor or a lapse in any certification relating to the device or kind of device or otherwise 2 If this subclause applies the sponsor must within 10 working days of the information ceasing to be accurate or complete ensure that the Director General or any person who maintains the database on behalf of the Director General is notified of the correct details or the complete information a
43. vicesNew SponsorDetailsUpdateForm doc WAND User Guide Version 3 1 Page 13 of 47 Verify the Manufacturer s Address Before beginning any device notification verify that the manufacturer s details are recorded in the database To search for the manufacturer of the device to be notified select Manufacturer Search from the Menu at the left hand side of the screen Type the name of the manufacturer in the Search box and click Search Web Assisted Notification of Devices Search for an Existing Manufacturer Manufacturer Name A list will appear with all manufacturers and addresses with that name which are on the Medsafe database If the manufacturer is on this list proceed to notify the device by selecting Add a New Device from the Menu on the left hand side of the screen Refer Step 5d If the manufacturer is address is not listed in WAND select the Notify a New Manufacturer link located in the Menu on the left hand side of the screen and complete the Manufacturer Notification Form that appears Manufacturer Notification Form Sponsor s Name Medsafe Address PO Box 5013 Wellington NEW ZEALAND Email kimberly_bridgewater moh_govt nz Manufacturer Name Address City A Country lt Select gt gt Phone Email Note The address of the manufacturer MUST be the street address A postal address will NOT be accepted on this form When all the details hav
44. with the notification is complete and correct The declaration is made by checking the box next to I Agree on the final draft of the notification form before submitting to Medsafe Note A Notification will not be accepted without a valid declaration Part 1 of the Declaration is mandatory for all New Zealand sponsors Part 1 compulsory being a person authorised to make this application hereby certify that a devices of the kind in question are medical devices and b the kind of device is correctly classified according to the medical device classifications and c the notified device will only be recommended by the sponsor for use for its intended purpose and d the information included in or with the application is complete and correct In electronically submitting this application to Medsafe hereby declare that in relation to this medical device the information given in this application and the above statements on this declaration form are current and correct Part 2 of the Declaration is optional Part 2 optional being a person authorised to make this application certify that e devices of that kind comply with the essential principles listed in the WAND on line user guide or f l i have available sufficient information to substantiate that compliance with the essential principles or ii have procedures in place to ensure that such information can be obtained from the manufacturer within t
45. y to notify a device which is very similar to a previously notified device The difference may only be a changed GMDN code and sponsor s reference Instead of entering all the information in again a copy of the previous notification can be made and amended to produce a new notification The process for doing this is as follows 1 2 Log into WAND Search the current notifications listed on the Home Current WAND Notifications screen and locate the notification to be used to base the new notification on Open the notification by clicking on it 4 Scroll to the bottom of the notification Click on the Copy Device button Status Active v Return to Draft Copy Device Less Details Printer Friendly The screen will now change to the Draft Medical Device Notifications folder The first entry at the top of the table will be a copy of the original notification with the additional word clone at the end of the sponsor reference 7 Click on the draft reference to open the copied notification 8 Review the copied notification and make all necessary changes for it to apply to the new device Once all the information has been updated move to the bottom of the screen and change the notification status from Draft to Final 10 Complete the declaration s 11 Click on the Submit button to notify the device to the WAND database WAND User Guide Version 3 1 Page 31 of
Download Pdf Manuals
Related Search