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QUESTION ANSWER Introduction What is a Change Notification? Change Notification application is meant to notify the Authority if there are any changes or proposed changes to any particulars provided in relation to the registration of medical device, and/or if there are any changes or proposed changes that may affect the safety, quality or efficacy of a registered medical device. How to apply for Change Notification? The application should be submitted online via Medcast 2.0+ system. The applicant should determine the correct Category for each change before submit the application online. Category How may I know the correct Category for Change to a registered medical device may be categorized into Category 1, Category 2 and Category 3. Please refer to my change(s)? section 5.3, Table 1 and Table 2 in the MDA/GD/0020 What If I still unable to determine the You may submit a request for confirmation on change notification category for registered medical device. Please refer correct category? Annex A in the MDA/GD/0020. This request need to be submitted by hardcopy to the Authority address together with the payment. Processing fee shall be paid through bank draft. What happened if my change(s) is Category 1 changes of medical devices that affect their safety and performance. The change(s) do not qualify for a categorized as Category 1? Change Notification. Please register the medical device with New Registration instead What happened if my change(s) is Category 2 are changes that require evaluation and endorsement from the MDA prior to categorized as Category 2? implementation of the change and before placing in the market. The change(s) can be notified and submitted through Medcast 2.0+ What happened if my change(s) is Category 3 changes may be implemented immediately upon submission of complete categorized as Category 3? documents. The change(s) can be notified and submitted through Medcast 2.0+ What happened if my change(s) are The implementation of changes are according to the category of cahnges. The change(s) can be notified and submitted categorized as Category 2 and Category 3? through Medcast 2.0+ Can I combine the change(s) under Yes, you may combine any changes under Category 2 and Category 3 under one application. There is no limitation for Category 2 and Category 3 under one the changes to be selected for one medical device application?

Can I combine change(s) for more than one Yes, you may combine change(s) for two up to 50 medical devices in on application.However the change(s) of each medical device to be submitted as one medical device must be similar change(s) and the change(s) only subject to the certain change(s) allowed as below; application? Category 2 5.5.1 Change in Manufacturing Facility, Process and Quality Management System (QMS) (a) All changes to manufacturing and/or sterilisation facilities with no changes to the manufacturing and/or sterilisation processes. Category 3 5.6.1 Change in Manufacturing Facility, Process and Quality Management System (QMS) (a) All changes to certificates for manufacturing and sterilisation facilities that i) involves an update of certificate QMS (for manufacturer); OR; ii) change in scope of the QMS certification which affect the registered medical device (that is not due to safety, and/or performance of the medical device) OR; iii) involves a cancellation of QMS scope on the certificate for any of the multiple existing manufacturing facilities that is related to the registered medical device (that is not due to safety, and/or performance of the medical device), OR; iv) involves the change in conformity assessment body with no change in scope of the certification, OR; v) involves the expansion of scope of the QMS certification which does not affect the registered medical device. Category 3 5.6.4 Changes to Registered Medical Devices Registration Information (c)All changes in the manufacturer information that only- Involve changes in manufacturer’s name and address, OR (ii) Involve changes in the manufacturing site’s name only. With no changes in the manufacturing site’s address Changes arising from the EU MDR/IVDR

My regsitered medical device(s) has been European Union (EU) is one of MDA reference regulatory agencies commonly referenced in abridged evaluation route impacted due to EU’s recent regulatory for medical device registration. With that trasition, the related changes will impact existing registered medical framework transition to Medical Devices devices, especially IFU and labels. Please refer to Table 3 in the MDA/GD/0020. Regulation (MDR) and IVD Regulation (IVDR). Do I need to notify the changes For changes that do not fall within the covered scope and criteria in the Table 3, approach as prescibed in Table 1 and arised from that transition to the Table 2 in the MDA/GD/0020. Authority? Turn-around time What is turn-around time for an Please refer to Table 5 in the MDA/GD/0020. application? Can I submit new application of change The Medcast 2.0+ system will not allow for another submission of a new change notification application for the same notification if there is a pending change medical device, when there is a pending change notification application. The pending application needs to be notification application in the system? completed before submitting a new change notification application. If the registered medical device has As the re-registration application is available to be applied prior one year to the expiry date, the applicant is advise to achieved the re-registration timeline and proceed with Change Notification application fist in order to notify the change to the Authority before submit for re- some changes need to be implemented to registration. However, for the medical device that has past the expiry date are not applicable to apply for Change the medical device, should the medical Notification application, since the medical device registration is expired. For this situation, the applicant is advise to device proceed with Change Nitification proceed for Re-registration application with application first or Re-registration application? Fee / Payment What is the fee apply for this type of All submission of notification of changes shall be accompanied with a fee as per the Table 3 in the MDA/GD/0020. application? What is the payment method allow for the FPX and Bank Draft type of application?