September 2024 brings several medical device regulatory developments in Singapore, new ASEAN classification guidance in Malaysia, imminent UDI implementation in Colombia, and more.
The Medical Devices Cluster (MDC) has released a draft guidance document for the Change Management Program (CMP) specifically for Software as a Medical Device (SaMD).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.
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.
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:
Additional updates:
Learn more about HSA Singapore Medical Device Registration.
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:
Learn more about MDA Malaysia Medical Device Registration.
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:
Learn more about INVIMA Colombia Medical Device Registration.
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.
Request reports:
Learn more about CDMR Canada Medical Device Registration & Approval.
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The IVDR transition includes structured processes IVD manufacturers must follow to engage with Notified Bodies. Many IVD manufacturers are interacting with Notified Bodies for the first time and must understand what is required to ensure a successful partnership. In this article, Dr. Oliver Eikenberg clarifies what manufacturers must prepare and when to engage a Notified Body for IVDR CE Marking.
Class D IVD manufacturers face fast-approaching IVDR transition deadlines, though some are more familiar with the regulatory process. In this article, Dr. Oliver Eikenberg discusses the difference between "new" and "old" Class Ds, and regulatory logistics they need to consider during the transition process.
Your IVD's intended purpose determines its classification, clinical evidence requirements, and clinical applications under the IVDR. Device companies will need a more robust intended purpose to fulfill IVDR criteria. In this article, Dr. Oliver Eikenberg explains the role of the intended purpose in IVDR compliance.
