The Medical Device Authority (MDA) has published the Third Edition of MDA/GD/0063: Harmonised Borderline Products in ASEAN, which outlines product categories that fall within or outside the scope of medical device regulation across ASEAN member states.
This guidance serves as a key reference to determine whether a product is regulated as a medical device or non-medical device, based on intended use, mode of action, and ASEAN consensus. The update supports consistent regulatory decisions, market clarity, and alignment with the ASEAN Medical Device Directive (AMDD).
The extensive Annex A now lists over 200 products, ranging from cosmetics, disinfectants, dental items, software, wearables, and surgical accessories, and defines each product’s regulatory classification.
Access the Guidance Document:
Third Edition of MDA/GD/0063 – Harmonised Borderline Products in ASEAN
Key Highlights
Expanded List of Harmonised Borderline Products
- Discussed in the 5th–14th AMDC Technical Committee meetings.
Enhanced Classification Rationale
- Includes considerations such as mode of action and combination product status.
Clarification of Overlapping Categories
- Clarifies the classification of products that frequently fall between medical device, drug, cosmetic, or consumer product categories.
Establishment of Annual Update Mechanism
- Sets the foundation for regular updates based on current ASEAN regulatory decisions.
Revision History
- Initial Release: August 2022
- Rev 2: December 2023
- Updated classification list based on 4th–10th AMDC Technical Committee (AMDTC) decisions.
- Rev 3 (Current): 13 June 2025
- Added decisions from the 9th–14th AMDC Technical Committee meetings
- Full Annex A now includes 210 borderline product listings
- Clarified regulatory status for combination products and common consumer goods
Implications to Clients
Incorrect classification may result in registration rejections, enforcement actions, or unnecessary regulatory burden. Clients are encouraged to consult the updated guidance to ensure accurate product classification and compliance with ASEAN member state requirements.
Effectivity
The updated guidance is effective from 13 June 2025.
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