# Weekly Regulatory News: Sep 3-9, 2024 ## SINGAPORE ### New Consultation: Guidance on Change Management Program (CMP) for SaMD The Medical Devices Cluster (MDC) has released a [draft guidance](https://www.hsa.gov.sg/announcements/consultation-on-guidance-on-change-management-program--cmp--for-samd/) document for the Change Management Program (CMP) specifically for Software as a Medical Device (SaMD). This guidance outlines regulatory requirements and the process for submitting CMPs, offering a new optional pathway within HSA's Premarket Product Registration and Change Notification (CN) systems. It also introduces the concept of pre-specified changes. Stakeholders are invited to provide their feedback on the draft during the consultation period from 26 August 2024 to 21 October 2024. ### NextGen MD Initiative: Streamlined Registration for Next-Generation Medical Devices The [NextGen MD Initiative](https://www.hsa.gov.sg/announcements/webinar-on-nextgen-md-initiative/) simplifies the registration process for next-generation medical devices, allowing applicants to leverage previously submitted data. This initiative applies to Class B, C, and D devices (excluding MD-drug combinations) and focuses on enhancing the registration efficiency for devices with similar characteristics to their predecessors. **Eligibility**: Next-gen devices must share the same product type, validation data (biocompatibility, sterilization, and shelf-life), and other identical criteria compared to the registered device. Only devices registered via the FULL or ABRIDGED route are eligible. **How to Apply:** Submit the "NextGen MD Form" along with the regular registration to [hsa\_md\_info@hsa.gov.sg](mailto:hsa_md_info@hsa.gov.sg), referencing the job application number. **Effective Date:** This opt-in initiative starts on 1 July 2024. ### Regulatory Updates for Therapeutic Product Registration (Effective 1 Aug 2024) The Health Sciences Authority (HSA) has introduced [several key updates](https://www.hsa.gov.sg/announcements/regulatory-updates-for-therapeutic-product-registration--effective-1-aug-2024-/) aimed at improving regulatory efficiency and clarity for therapeutic product registration, effective from 1 August 2024. **Key changes include:** 1. New Evaluation Milestone Tool: A tool to estimate key evaluation timelines for NDA, GDA, and MAV-1 applications. 2. Cloud-Based Submission (EasiShare): A new option for dossier submission through EasiShare, alongside existing methods. 3. Post-Approval Change Guidelines: A list of changes that no longer require notification to HSA, including product labelling changes for e-labelling. 4. Patent Declaration Updates: Changes in the Health Products Regulations with revised patent forms now available. 5. Swissmedic as a Reference Agency: Swissmedic is added as a reference agency for product evaluation. **Additional updates:** - GMP compliance requirements for chemical drug substance manufacturers will be mandatory from 1 October 2024. - Implementation timelines for the eCTD platform have been extended, with regular progress updates. **Learn more about** [**HSA Singapore Medical Device Registration**](https://www.pureglobal.com/markets/singapore)**.** ## MALAYSIA ### MDA Updates ASEAN Medical Device Classification Guidance The [Malaysian Medical Device Authority (MDA)](https://www.pureglobal.com/glossary/malaysia-mda) has released [revised guidance](https://www.regdesk.co/mda-revised-guidance-on-asean-classification-overview/) on classifying medical devices under the ASEAN Medical Device Directive (AMDD). This update standardizes classification across ASEAN countries, helping manufacturers and authorized representatives comply with regional regulations. **Key points:** - Devices are classified from Class A (low-risk) to Class D (high-risk). - Includes detailed annexes for specific device classifications. - Annual updates ensure alignment with the latest regulatory and technological changes. **Learn more about** [**MDA Malaysia Medical Device Registration**](https://www.pureglobal.com/markets/malaysia)**.** ## COLOMBIA ### Colombia to Implement Unique Device Identifier (UDI) for Medical Devices and IVDs Starting 2024 Updated: Aug 24, 2023 Colombia is set to implement the [Unique Device Identifier (UDI) system](https://www.esebip.com/post/unique-device-identifier-udi-for-mds-and-ivds-to-be-implemented-in-colombia-as-from-2024) for medical devices (MDs) and in-vitro diagnostics (IVDs) beginning in 2024. The UDI system ensures clear identification and traceability of devices on the market. **Key deadlines:** - **By Feb 8, 2024:** UDI-DI must be provided for Class III MDs and IVDs. - **By Aug 8, 2025:** UDI-DI must be submitted for Class IIb MDs and Class II IVDs. - **By Feb 8, 2026:** UDI-DI for Class IIa, Class I MDs, and Class I IVDs. **Learn more about** [**INVIMA Colombia Medical Device Registration**](https://www.pureglobal.com/markets/colombia)**.** ## CANADA ### Medical Device Reports and Publications Medical devices, as defined by the Food and Drugs Act, include a range of health instruments for treatment, diagnosis, and disease prevention. Access reports and publications related to medical devices here. - [Summary Basis of Decision](https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/summary-basis-decision.html): Details on Health Canada's approval decisions for drugs and devices. - [Medical Devices Performance Reports](https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medical-devices.html): Metrics on pre-market review processes, including submission and licensing timelines. **Request reports:** - For quarterly (2020-2024) or annual (2018-2024) reports, email: [publications@hc-sc.gc.ca](mailto:publications@hc-sc.gc.ca). - For more information, contact the Medical Devices Directorate at: [meddevices-instrumentsmed@hc-sc.gc.ca](mailto:meddevices-instrumentsmed@hc-sc.gc.ca). **Learn more about** [**CDMR Canada Medical Device Registration & Approval**](https://www.pureglobal.com/markets/canada)**.** [Canonical page](https://www.pureglobal.com/news/weekly-regulatory-news-6)