SINGAPORE

New Consultation: Guidance on Change Management Program (CMP) for SaMD

The Medical Devices Cluster (MDC) has released a draft guidance document for the Change Management Program (CMP) specifically for Software as a Medical Device (SaMD).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 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, 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 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.

MALAYSIA

MDA Updates ASEAN Medical Device Classification Guidance

The Malaysian Medical Device Authority (MDA) has released revised guidance 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.

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 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.

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: Details on Health Canada's approval decisions for drugs and devices.
• Medical Devices Performance Reports: 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.
• For more information, contact the Medical Devices Directorate at: meddevices-instrumentsmed@hc-sc.gc.ca.

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