English — complete official PDF expression

OFFICIAL ANNOUNCEMENT AND SUBMISSION GUIDE SUBJECT: INTRODUCTION OF THE AUTOMATED RE-REGISTRATION ROUTE IN MeDC@St 2.0+ FOR STREAMLINED MARKET ACCESS AND CONTINUOUS SUPPLY OF MEDICAL DEVICES Dear All Medical Device Industry Stakeholders and Registrants, The Medical Device Authority (MDA) extends its highest regards to all valued stakeholders. This announcement serves to inform the industry that the MDA is officially introducing the new Automated Re-Registration Route within the MeDC@St 2.0+ platform, effective from 13th July 2026. Re-registration applications submitted on or after this date will be eligible for this streamlined pathway, while applications submitted prior to this date shall continue to follow the normal evaluation route. Please be advised that this announcement also serves as the operational user guide to provide comprehensive details on the eligibility requirements, implementation scope, and form modifications required for this new route. USER GUIDE: AUTOMATED RE-REGISTRATION APPLICATION IN MeDC@St 2.0+ 1. Introduction The Automated Re-Registration Route in MeDC@St 2.0+ enables eligible registration holders to renew their medical device registrations through an optimized, automated submission process. This route applies to medical devices that meet all eligibility criteria specified under the Medical Device Act 2012 (Act 737), its subsidiary regulations, relevant MDA guidance documents, and the requirements outlined in this announcement. 2. Eligibility & General Requirements Before initiating an automated re-registration application, the registration holder shall ensure strict compliance with the following criteria: • Licensing Status: The establishment must hold a valid Manufacturer License or Authorized Representative (AR) License. • No Pending Applications: No active Change Notification (CN) or Change of Ownership (COO) applications must exist for the device in MeDC@St 2.0+. • Validity Window: The current medical device registration certificate must be active and within one (1) year prior to its expiration date. Pre-Market Control Division I registration@mda.gov.my Page 1 of 21

• Conformity Assessment: The device must have been previously registered via either the Full Conformity Assessment or the Verification pathway, and the corresponding CAB certificate must remain valid. • Data Integrity: All registration data must reflect the latest information approved by the MDA. No unapproved changes are permitted unless explicitly specified in this announcement. • Registration Certificate Status: The device must not be subject to any active registration rejection, suspension, or cancellation status. Note: This user guide must be read in conjunction with the current edition of MDA/GD/0070 (Medical Device Registration Submission Guide for Conformity Assessment by Way of Verification Process and Submission of Application in MeDC@St). IMPLEMENTATION SCOPE & FORM REQUIREMENTS PART A: CLASS A MEDICAL DEVICES The table below outlines the re-registration requirements and regulatory expectations for each section of the Class A Medical Device Registration Form. The requirements and submissions shall be read together with the current edition of MDA/GD/0070. No. MeDC@St 2.0+ Re-Registration Required Information & Supporting Documents Application Form Requirement (Ref: Annex 3 of MDA/GD/0070) Section Name 1 Medical Device Non-editable System-generated from approved registration Classification record. 2 Product Status Non-editable System-generated from approved registration Determination record. 3 Medical Device Non-editable System-generated from approved registration General record. Information 4 Medical Device Non-editable System-generated from approved registration Grouping record. 5 Additional Non-editable System-generated from approved registration Requirements record. 6 Manufacturer Update Required Submit a valid and current QMS certificate [(e.g., Information ISO 13485, MDSAP Certificate, US FDA QMSR, Japan Ministerial Ordinance No. 169, or ISO 9001 (for empty gas cylinders only)]. Note: ONLY the QMS certificates specified above are accepted under the automated re-registration Pre-Market Control Division I registration@mda.gov.my Page 2 of 21

No. MeDC@St 2.0+ Re-Registration Required Information & Supporting Documents Application Form Requirement (Ref: Annex 3 of MDA/GD/0070) Section Name route. Submission of any other QMS certification shall require a CN application and approval by MDA prior to re-registration. 7 Pre-Market Update Required Optional: Submit updated pre-market clearance or Clearance / approval documentation, where available, to Approval support the re-registration application. 8 Labelling Update Required Submit the latest medical device labelling reflecting the assigned MDA registration number and AR information. Note: Any other labelling changes are not permitted under the re-registration process and shall be submitted through a CN application prior to re-registration. 9 Post-Market Update Required Submit updated Post-Market Surveillance (PMS) Surveillance and vigilance information in accordance with the (PMS) & Vigilance requirements specified in Annex 3 of MDA/GD/0070, including the latest available PMS records covering the preceding registration period. 10 Declaration of Update Required Submit an updated Declaration of Conformity Conformity (DoC) (DoC). PART B: CLASS B, C, AND D MEDICAL DEVICES The table below outlines the re-registration requirements and regulatory expectations for each section of the Class B, C and D Medical Device Registration Form. The requirements and submissions shall be read together with the current edition of MDA/GD/0070. No. MeDC@St 2.0+ Re-Registration Required Information & Supporting Application Form Requirement Documents (Ref: Annex 4 of MDA/GD/0070) Section Name 1 Medical Device Non-editable System-generated from approved registration Classification record. 2 Medical Device Update Required Updates are permitted only for registered General (Certain Fields) information not captured in the form during the Information initial registration. Permitted fields are: Pre-Market Control Division I registration@mda.gov.my Page 3 of 21

No. MeDC@St 2.0+ Re-Registration Required Information & Supporting Application Form Requirement Documents (Ref: Annex 4 of MDA/GD/0070) Section Name • Device Meant for Export Only; • Combination Product status (must be supported by NPRA AR/EL); • Formulation for devices containing active ingredients, poisons, or drugs (e.g., creams, gels, sprays, lubricants), as registered. All other fields are non-editable. 3 Medical Device Non-editable System-generated from approved registration Grouping record. 4 Common Update Required Updates shall be submitted for specific fields in Submission (Certain Fields) alignment with Annex 4 of MDA/GD/0070, Dossier Template including updated Clinical Evaluation Reports (CSDT) (CER) / Clinical Performance Reports (CPR), latest medical device labelling reflecting the assigned MDA registration number and AR information and latest risk analysis. Note: • For IVD cluster grouping, update the information in Section 3 in the MeDC@St 2.0+ application form. • Any other changes are not permitted under the re-registration process and shall be submitted through a CN application prior to re- registration. All other fields are non-editable. 5 Manufacturer Update Required Submit a valid and current QMS certificate (e.g., Information ISO 13485, MDSAP Certificate, US FDA QMSR, Japan Ministerial Ordinance No. 169). Note: ONLY the QMS certificates specified above are accepted under the automated re-registration route. Submission of any other QMS certification shall require a CN application and approval by MDA prior to re-registration. 6 Pre-Market Update Required Optional: Submit updated pre-market clearance or Clearance / approval documentation, where available, to Approval support the re-registration application. Pre-Market Control Division I registration@mda.gov.my Page 4 of 21

No. MeDC@St 2.0+ Re-Registration Required Information & Supporting Application Form Requirement Documents (Ref: Annex 4 of MDA/GD/0070) Section Name 7 Conformity Update Required Update Required if the current CAB certificate Assessment Body / Non-editable has expired, requiring the submission of a (CAB) recertification assessment from a registered CAB. Non-editable if the existing CAB certificate remains valid. 8 Post-Market Update Required Submit updated Post-Market Surveillance (PMS) Surveillance and vigilance information in accordance with the (PMS) & Vigilance requirements specified in Annex 4 of MDA/GD/0070, including the latest available PMS records covering the preceding registration period. 9 Declaration of Update Required Submit an updated Declaration of Conformity Conformity (DoC) (DoC). NOTE • Changes/updates to registered medical device information are prohibited during the re- registration process unless permitted under the sections identified above or within MDA/GD/0070. Any other changes shall be approved via the CN pathway prior to initiating the automated re-registration application. • MDA reserves the right to request additional information or conduct further regulatory review where deemed necessary. Pre-Market Control Division I registration@mda.gov.my Page 5 of 21

RE-REGISTRATION FLOWCHART The process flow below outlines the system logic execution for the Automated Re-Registration Route: Start No Check General Eligibility End Parameters Yes Create a Re-registration Application in the MeDC@St 2.0+ Update the Form based on the requirements stated in Part A and Part B Submit a complete application Payment of Application Fee as per Fifth Schedule of MDR 2012 Payment of Registration Fee as per Fifth Schedule of MDR 2012 Issuance of Registration Electronic Certificate Complete and listed in the MDAR Thank you. For further information and inquiries, please contact: Pre-Market Control Division Medical Device Authority (MDA) Ministry of Health (MoH) Level 5, Prima 9 (Block 3547) Prima Avenue II, Persiaran APEC 63000 Cyberjaya, Selangor Darul Ehsan Date: 10th July 2026, Revision 2 Pre-Market Control Division I registration@mda.gov.my Page 6 of 21

FREQUENTLY ASKED QUESTIONS (FAQs) General Information and Eligibility 1. What is the Automated Re-Registration Route? The Automated Re-Registration Route is a streamlined pathway within the MeDC@St 2.0+ platform that allows eligible registration holders to renew their medical device registrations automatically, without undergoing the standard evaluation route. 2. When does this new route take effect? The official implementation date is 13 July 2026. Re-registration applications submitted before this date will continue to be processed through the standard evaluation route. 3. Who is eligible to use this route? To qualify, the registration holder must meet all of the following criteria: • Hold a valid Manufacturer Licence or Authorized Representative (AR) Licence. • Have no active or pending Change Notification (CN) or Change of Ownership (COO) applications for the device in MeDC@St 2.0+. • Hold a current registration certificate that is active and within one (1) year prior to its expiration date. • The device must have been previously registered via Full Conformity Assessment or Verification. • Hold a valid Conformity Assessment Body (CAB) certificate. • The device registration must not be under rejection, suspension, or cancellation status. • All information submitted must reflect the latest records approved by the MDA. 4. Will the current automated re-registration approach continue to apply to recently registered devices? The current approach under MeDC@St 2.0+ is implemented to facilitate a smoother re-registration process and reduce administrative burden for registration holders, while ensuring that the registration information remains current and compliant with the applicable regulatory requirements. This approach will continue to be reviewed by MDA as part of the ongoing improvement of the registration process. A similar approach is also planned to be Pre-Market Control Division I registration@mda.gov.my Page 7 of 21

implemented under MeDC@St 3.0, as shared with industry during the MDA– Industry Engagement Session on MeDC@St 3.0. Any future updates or changes to the re-registration process will be communicated by MDA through the appropriate channels. 5. When can an establishment submit an Automated Re-Registration application through MeDC@St 2.0+? The Automated Re-Registration function is available within one (1) year before the expiry date of the current medical device registration certificate. Establishments may submit the re-registration application during this period, subject to the applicable eligibility requirements. 6. How does MeDC@St 2.0+ determine whether a medical device is eligible for the Automated Re-Registration Route? Based on the eligibility criteria established for the Automated Re-Registration Route, the MeDC@St 2.0+ system will identify and allow eligible registered medical devices to undergo the Automated Re-Registration process. Under the current MeDC@St 2.0+ system limitation, there is no separate selection option labelled “Automated Re-Registration”. The applicable streamlined process is triggered based on the eligibility criteria and the information provided in the re-registration application. 7. Will MeDC@St provide an automatic reminder or notification when the CAB certificate expires or requires updating after re-registration? Under the current MeDC@St 2.0+ system, there is no automated reminder or notification to alert establishments regarding the expiry or renewal of the CAB certificate, or the need to submit a Change Notification (CN). Registration holders are responsible for monitoring the validity of their conformity assessment documents and ensuring that the latest approved information is maintained throughout the validity period of the medical device registration. Enhancements to include system notifications and reminders will be considered as part of the development of MeDC@St 3.0. 8. What is the maximum file size for documents uploaded during automated re-registration? The maximum file size for each uploaded document is 30 MB. Pre-Market Control Division I registration@mda.gov.my Page 8 of 21

9. What should an establishment do if it decides not to proceed with re- registration? If the establishment decides not to proceed with the re-registration application, no further action is required for the automated re-registration process. However, the establishment shall ensure that the medical device registration remains valid if the device continues to be placed on the Malaysian market 10. Does automated re-registration require manual evaluation by an MDA officer? No routine manual evaluation is conducted. Eligible applications are processed through automated system validation based on the prescribed requirements. 11. Will the application be automatically approved upon submission, or can MDA provide comments or request additional information? The re-registration process is automated. If the application fulfills all eligibility criteria and the required updates/documents specified under the Automated Re- Registration Route, the system will perform an automated validation during the application process. 12. Which existing guidance documents apply to this process? This FAQ and the Automated Re-Registration Guide must be read in conjunction with the latest edition of MDA/GD/0070 (Medical Device Registration Submission Guide for Conformity Assessment by Way of Verification Process and Submission of Application in MeDC@St). 13. Who can I contact for further inquiries? Inquiries may be directed to the Pre-Market Control Division via email: registration@mda.gov.my CAB Certificate & Conformity Assessment 1. What is the role of CABs under the Automated Re-Registration Route? The role of CABs remains unchanged. CABs continue to be responsible for conducting conformity assessments and issuing the relevant conformity assessment certificates in accordance with the applicable regulatory requirements. Pre-Market Control Division I registration@mda.gov.my Page 9 of 21

2. Is the registration holder required to maintain a valid CAB certificate? Registration holders are responsible for ensuring that the conformity assessment status of their medical devices remains valid throughout the validity period of the registration certificate. During Re-Registration Submission: If the CAB certificate has expired at the time of submission, the registration holder must provide an updated recertification assessment certificate issued by a registered CAB directly into the application form. If the CAB certificate remains valid, the field will remain non- editable. Post-Registration (MeDC@St 2.0+): For devices successfully re-registered through the Automated Re-Registration Route MeDC@St 2.0+, registration holders are not expected to submit an updated CAB Certificate and Report through CN at this time to reflect the renewal of an expired CAB Certificate. The latest CAB Certificate and Report shall be retained by the registration holder and made available to MDA upon request. Future Updates (MeDC@St 3.0): The MDA is developing functionalities that will allow CABs to upload conformity assessment certificates and reports directly into the system. Further announcements will be made once the operational procedures have been finalized. 3. How long must the CAB Certificate remain valid when submitting an automated re-registration application? For the Automated Re-Registration Route, it is sufficient that the CAB Certificate is valid at the time of application submission. There is currently no prescribed minimum remaining validity period for the CAB Certificate. As long as the registration holder holds a valid CAB Certificate on the date the re-registration application is submitted through MeDC@St 2.0+, the eligibility requirement relating to CAB certification is considered fulfilled. 4. Can an application proceed through automated re-registration if the CAB is no longer registered or active, but the product verification certificate remains valid? The application may proceed through the Automated Re-Registration Route, provided that the CAB Certificate issued by the CAB remains valid at the time of re-registration. 5. How does MDA monitor the validity of the CAB Certificate throughout the registration validity period? Continued compliance is maintained through various regulatory controls, including post-market surveillance and vigilance activities, change notification Pre-Market Control Division I registration@mda.gov.my Page 10 of 21

requirements, re-registration processes, establishment licence renewals, audits, inspections, and enforcement activities. Manufacturers and establishments are responsible for ensuring that the conformity assessment evidence, including the CAB Certificate, remains valid and applicable throughout the medical device lifecycle. Information obtained through post-market surveillance activities, complaint investigations, audits, inspections, or other regulatory activities may prompt MDA to verify the continued validity and applicability of the CAB Certificate. Where MDA becomes aware of any suspension, withdrawal, expiry, or non-compliance relating to the CAB Certificate, appropriate regulatory actions may be taken in accordance with the Medical Device Act 2012 (Act 737) and its subsidiary regulations 6. Can a newer CAB Certificate be uploaded before the existing certificate expires? A newer CAB Certificate may be voluntarily uploaded before the existing certificate expires under Section 4.0 (CSDT), Document 9 – Miscellaneous (MISC). 7. What documents are required for CAB assessment under automated re- registration? The requirements for CAB assessment should be read together with MDA/GD/0070 and other applicable MDA guidance documents. 8. Are CSDT and test reports still required to be submitted to the CAB? The requirements for the Automated Re-Registration Route should be read together with MDA/GD/0070 and other applicable MDA guidance documents. The requirements for the submission of the relevant documents to the CAB are as specified in MDA/GD/0070. 9. If the CAB Certificate expires after the medical device has been re- registered, is re-certification with the CAB required? Registration holders are responsible for ensuring that the conformity assessment status of their medical devices remains valid throughout the validity period of the registration certificate. An updated CAB Certificate and Report should be obtained before the expiry of the existing CAB Certificate to ensure the continued validity of the conformity assessment status. Pre-Market Control Division I registration@mda.gov.my Page 11 of 21

For devices that have successfully undergone Automated Re-Registration in MeDC@St 2.0+, registration holders are not expected to submit an updated CAB Certificate and Report through CN at this time solely to reflect the renewal of an expired CAB Certificate. This approach considers the interim nature of the Automated Re-Registration Route in MeDC@St 2.0+ and the current system limitations of the CN functionality. Accordingly, following the approval of an Automated Re-Registration application, registration holders may retain the latest CAB Certificate and Report in their records and make them available to the Authority upon request 10. If a Change Notification (CN) for a manufacturer change has been approved, but the CAB Certificate still bears the previous manufacturer's name, is a new CAB review required before automated re-registration? A new CAB review is not required because the CAB Certificate reflects the previous manufacturer's name, provided that the CN has been approved by MDA and the CAB Certificate remains valid. MDA can verify the approved changes and application history through the MeDC@St system. Registration holders should ensure that the Automated Re- Registration application reflects the latest information approved by MDA and that the CAB Certificate is valid. 11. If the CAB Certificate is still valid at the time of submission but expires before payment is completed, will the application proceed? The CAB Certificate must be valid prior to and at the time of submission of the Automated Re-Registration application. The application may proceed subject to successful completion of the required submission and payment steps. 12. Should an establishment wait for the renewed CAB certificate before submitting a re-registration application Establishments should plan the CAB certificate renewal and re-registration timelines to ensure the application is submitted before the existing registration expires. Eligible applications under the Automated Re-Registration Route are processed through automated system validation, reducing the time required for re-registration. However, a valid certificate of conformity is still required at the time of submission. Establishments are advised to allow sufficient time for the CAB certificate renewal and re-registration process to avoid any lapse in registration. Pre-Market Control Division I registration@mda.gov.my Page 12 of 21

13. Which Change Notification category should be used to update the validity of a CAB Certificate? Under the current MeDC@St 2.0+ process, an updated CAB Certificate and Report does not need to be submitted through a Change Notification (CN) to reflect the renewal of an expired CAB Certificate for devices that have successfully undergone Automated Re-Registration. The latest documents should be retained and made available to MDA upon request. A newer CAB Certificate may also be voluntarily uploaded before the existing certificate expires under Section 4.0 (CSDT), Document 9 – Miscellaneous (MISC). Under MeDC@St 3.0, updates to the CAB Certificate and Verification Report will be submitted through the Change Management – Update for Re-Registration pathway. The updated documents will be uploaded directly into the system by the CAB. Further details will be communicated before MeDC@St 3.0 implementation. 14. If the CAB Report and Certificate are still valid in MeDC@St 2.0+, do they need to be re-uploaded during automated re-registration? If the existing CAB Certificate and Report remain valid, they do not need to be re- uploaded for automated re-registration. Registration holders are responsible for ensuring that the conformity assessment status of the medical device remains valid throughout the validity period of the registration certificate. An updated CAB Certificate and Report should be obtained before the existing certificate expires. For devices successfully re-registered through the Automated Re-Registration Route in MeDC@St 2.0+, the updated CAB Certificate and Report do not need to be submitted through CN solely due to the renewal of an expired certificate. The latest documents should be retained and made available to MDA upon request. A newer CAB Certificate may also be voluntarily uploaded before the existing certificate expires under Section 4.0 (CSDT), Document 9 – Miscellaneous (MISC) in MeDC@St 2.0+. Pre-Market Control Division I registration@mda.gov.my Page 13 of 21

Document Submission & Updates 1. Where should supporting documents that cannot be updated in the permitted sections be uploaded? Any supporting documents that are not permitted to be updated under the designated sections of the Automated Re-Registration Route, and which do not affect the safety and performance of the medical device, shall be submitted as follows: ● For Class B, C and D: under Section 4.0 of the CSDT, Document 9 (MISC). ● For Class B IVD Cluster Section 3.0 Grouping > CSDT > MISC ● For Class A: under Section 10 – Declaration of Conformity (DoC), under "Any Additional Information". The registration holder shall ensure that the registered information is updated and maintained in accordance with the applicable regulatory requirements. 2. Can pre-clinical reports, such as biocompatibility, stability, or validation reports, be updated during the Automated Re-Registration Route? Updates or amendments to pre-clinical reports are not permitted under the designated sections of the Automated Re-Registration Route, as such changes may require further regulatory evaluation by MDA. Any update or amendment to pre-clinical reports must be submitted through the appropriate Change Notification (CN) application for MDA’s review and assessment. As stated in the announcement, any updates to registered medical device information are prohibited during re-registration unless permitted under the designated sections of the application form and MDA/GD/0070. 3. Should the previous version of a document be removed when an updated document is uploaded in MeDC@St? The registration holder should remove the previous version of the document and retain only the latest updated version in MeDC@St. This is to ensure that the information submitted reflects the latest approved and applicable documentation for the registered medical device. 4. Can automated re-registration be completed without document submission if there are no changes? The Automated Re-Registration Route still requires the submission of relevant information and documentation based on the applicable regulatory requirements. Pre-Market Control Division I registration@mda.gov.my Page 14 of 21

5. Is the CSDT required to be updated or resubmitted during automated re- registration? The CSDT is not required to be updated for re-registration. The latest applicable CER, risk analysis and labelling shall be updated and maintained as part of the supporting documentation, where applicable. Any changes that affect the registered information or require regulatory assessment must be submitted through the appropriate CN and approved by MDA before re-registration. 6. Can a commitment letter be submitted if the updated CER, CPR or Risk Analysis is not yet available at the time of re-registration? The registration holder must submit the latest applicable information and supporting documents during the re-registration application. The CER, CPR and Risk Analysis, where applicable, should be updated to reflect the current status of the medical device. A commitment letter is not a substitute for the required updated documentation. The registration holder is responsible for ensuring that all information and supporting documents submitted for re-registration are complete and up to date. 7. Can information or documents be updated after submitting an automated re-registration application? Only designated fields may be updated during automated re-registration. Any changes outside these permitted fields must obtain prior approval through a CN application before initiating the re-registration process. 8. Can automated re-registration proceed if the CE Certificate is no longer available but the existing CAB Certificate is still valid? Pre-market approval documentation is a voluntary supporting document for the Automated Re-Registration application. The Automated Re-Registration application may proceed provided that the existing CAB Certificate remains valid and the device continues to meet the eligibility requirements. However, as the manufacturer has discontinued the use of the CE marking for the device, the registration holder shall submit a CN application prior to re- registration to update the relevant labelling information, including the removal of the CE marking symbol where applicable. 9. Can additional pre-market approval information that was not previously declared in MeDC@St be submitted during re-registration? Additional pre-market approval information that was not previously declared may be submitted as supporting documentation for the re-registration application. Pre-Market Control Division I registration@mda.gov.my Page 15 of 21

10. Can the updated ISO 13485 Certificate issued to a contract manufacturer be submitted directly during automated re-registration? Where the ISO 13485 Certificate is issued to the contract manufacturer rather than the legal manufacturer, the updated QMS documentation must first be submitted through a Change Notification (CN) application for MDA’s review and assessment. Once the updated QMS information has been approved by MDA, the registration holder may proceed with the Automated Re-Registration application Note: Failure to comply with these requirements may constitute a breach of the regulatory requirements under Act 737 and may result in enforcement action being taken by the Authority. 11. Can an updated QMS Certificate with only a renewed validity period be submitted directly during re-registration? If the only change is the renewal of the QMS Certificate validity, with no changes to the certification scope, certification body, legal manufacturer, manufacturing site or other registered particulars, the updated certificate may be submitted as part of the re-registration application. A separate CN is not required to update the certificate validity. However, if the QMS update affects the registered information, the appropriate Change Notification (CN) must be submitted and approved before proceeding with re-registration. The change management approach for QMS updates will be implemented under MeDC@St 3.0. For the Automated Re-Registration Route in MeDC@St 2.0+, updates remain subject to the current system capabilities and permitted editable section. 12. Is a declaration of no adverse incidents acceptable if there are no post- market issues? An updated PMS report shall be submitted. Where there are no reported adverse incidents, FSCAs, recalls, or other post-market issues, a declaration letter confirming the absence of such issues may be provided as supplementary evidence. Pre-Market Control Division I registration@mda.gov.my Page 16 of 21

13. Can UDI information be updated during automated re-registration? A dedicated UDI field is not currently available in MeDC@St 2.0+. The UDI field will be available under MeDC@St 3.0. For voluntary updates of UDI information under the current system, the registration holder may update the relevant device identifier information under the List of Configuration, where applicable. Any changes to the registered information shall subsequently be submitted through a CN application in accordance with the applicable requirements. 14. Can discontinued models be removed from the Medical Device Grouping during automated re-registration? The Medical Device Grouping section is not editable under the Automated Re- Registration Route. Any changes to the registered grouping, including the removal of discontinued models, must be submitted through the Change Notification (CN) process and approved by MDA before proceeding with re- registration. Change Notification (CN) & Changes to Registered Information 1. Are CN approval letters and previously approved CN documents required for automated re-registration? CN approval letters and the documents approved under the respective CN applications are not required to be submitted for automated re-registration. MDA is able to verify the approved changes and application history through the MeDC@St system where a CN application has been submitted and approved. The registration holder only needs to ensure that the re-registration application reflects the latest information approved by MDA. 2. Can a Change Notification (CN) be submitted while an automated re- registration application is being processed? A related CN application cannot be submitted concurrently with the automated re- registration application. Where a CN is required, it must be submitted and approved before proceeding with re-registration. Pre-Market Control Division I registration@mda.gov.my Page 17 of 21

3. If the regulatory status changes in a recognised country due to a commercial decision, is a Change Notification (CN) required before automated re-registration? The registration holder must submit a CN application before re-registration to update the relevant labelling information, including removal of the CE marking symbol, where applicable. The Automated Re-Registration application should reflect the latest information approved by MDA. 4. If a Change Notification (CN) is not completed before the registration expires, can a new registration application be submitted? A new registration application can be submitted. However, it will be processed as a new application and will generate a new registration number that is not linked to the previous registration record. Please note that if the changes fall under Category 1, a new registration is required. 5. If a Change Notification (CN) is submitted to update the labelling/IFU, can the intended use also be updated during re-registration? The intended use fields are non-editable under the Automated Re-Registration Route. Any changes to the intended use resulting from IFU or labelling changes must be submitted and approved through the appropriate CN application before initiating re-registration. 6. Can non-reportable labelling changes be updated during automated re- registration? For the purpose of the Automated Re-Registration Route, registration holders may update labelling information that reflects the latest approved information, including non-reportable labelling updates, where applicable. However, any labelling changes that constitute a reportable change under the applicable CN requirements shall continue to be submitted through the appropriate CN application for MDA’s review and approval prior to being reflected in the registration information. 7. If updated labelling has already been submitted and approved through a Change Notification (CN), does it need to be re-uploaded during automated re-registration? Any labelling changes that constitute a reportable change under the applicable CN requirements shall be submitted through the appropriate CN application for MDA’s review and approval prior to being reflected in the registration information. For the purpose of the Automated Re-Registration Route, registration holders may update labelling information that reflects the latest approved information by MDA. Pre-Market Control Division I registration@mda.gov.my Page 18 of 21

Fees, Timeline and Registration Certificate 1. What are the required fees? Fees are prescribed under the Fifth Schedule of the Medical Device Regulations 2012 and the Medical Device Regulations (Amendment) 2025. Device Classification Application Fee Registration Fee Class A RM 500 RM 750 Class B RM 250 RM 1,000 Class C RM 500 RM 2,000 Class D RM 750 RM 3,000 Combination Product RM 750 RM 5,000 2. How are the application and registration fees charged under automated re- registration? The application fee and registration fee are issued through two separate invoices. The registration fee invoice is generated after payment of the application fee and successful system validation. Upon successful submission of the re-registration application, an invoice for the application fee will be generated. Once the application fee has been paid and the application successfully passes the system validation process, a separate invoice for the registration fee will be generated. The re-registration certificate will only be issued upon successful payment of the registration fee and completion of the required system processes. 3. What is the expected processing time after payment for issuance of the electronic registration certificate and publication in the MDAR? There is currently no prescribed regulatory or operational processing timeline. After successful submission, payment of the application fee and successful system validation, the registration fee invoice will be generated. The electronic re- registration certificate will be issued after successful payment of the registration fee and completion of the required system processes. 4. Can the application fee be refunded if the automated re-registration application is unsuccessful? The application fee is non-refundable as it is imposed for the processing of the application. Pre-Market Control Division I registration@mda.gov.my Page 19 of 21

5. Does the evaluation timeline differ between Class A and Class B, C and D medical devices? No specific difference in evaluation timeline is prescribed. Processing depends on the applicant’s successful completion of the required submission and payment steps. 6. What is the validity period of the registration certificate? The medical device registration certificate is valid for a period of five (5) years. 7. What is the validity start date of the re-registration certificate? The validity period of the re-registration certificate will continue from the expiry date of the previous registration certificate, provided that the application fee is paid before the expiry of the existing registration certificate. 8. What registration number will be assigned upon re-registration? The registration number will remain unchanged from the previous registration certificate. If a new registration number is generated during the re-registration process, this is considered a system error. Establishments experiencing this issue should contact the MeDC@St Helpdesk and provide the relevant application details for rectification. Medc@St 3.0 & Future System Enhancements 1. When will MeDC@St 3.0 be officially implemented? MeDC@St 3.0 is currently under development, with the core modules targeted for rollout in December 2026. Further announcements will be made by MDA before official implementation. 2. How will documents uploaded under MISC on a voluntary basis be transferred to MeDC@St 3.0? MeDC@St 3.0 operates on a new system architecture. While standard/matching data fields will be migrated from MeDC@St 2.0+, documents uploaded under fields not captured in the current system may not migrate automatically. Applicants may be required to re-upload or re-enter specific information upon the launch of MeDC@St 3.0. MDA will provide guidance to ensure a smooth transition. Pre-Market Control Division I registration@mda.gov.my Page 20 of 21

3. May I confirm whether the same processflow for re-registration will be followed inMedCast 3.0 after its launch? The current workflow in MeDC@St 2.0+ is an interim route. While the core concept of a streamlined re-registration pathway will be maintained, MeDC@St 3.0 will feature an updated workflow incorporating dedicated Change Management (under MDA/GD/0072) and CAB module integration. Revision History • Initial Release: 6th July 2026 • Revision 1: 10th July 2026 – Added FAQ • Revision 2: 14th October 2026 – Updated FAQ Pre-Market Control Division I registration@mda.gov.my Page 21 of 21