Effective January 1st, 2025, ISO 13485 certificates accepted for HSA medical device dealer license applications would be those issued by SAC-accredited certification bodies.
BSI GROUP SINGAPORE PTE. LTD. has been diligently working on expanding our scope since receiving our accreditation from SAC in June 2023. We are pleased to inform you that our accreditation covers 5 main technical areas in full, with 2 currently under application*.
We are prepared to accept applications for technical areas that our accreditation currently covers:
- Non-Active Medical Devices
- Active Medical Devices (Non-implantable)
- Active Implantable Medical Devices (*devices for imaging, monitoring devices, devices for radiation therapy and thermo therapy)
- In Vitro Diagnostic Medical Devices (IVD)
- Sterilization Method for Medical Devices
- *Devices Incorporating/Utilizing Specific Substances/Technologies (*medical devices incorporating medicinal substances, medical devices utilizing tissues of animal origin, medical devices incorporating derivates of human blood, medical devices utilizing micromechanics, medical devices utilizing nanomaterials, medical devices utilizing biological active coatings and/or materials or being wholly or mainly absorbed, Medical devices incorporating or utilizing specific substances/technologies/elements, other than specified above)
- Parts or Services
Note: *Main/Technical areas under application.
The accreditation schedule for BSI Singapore (Certificate No. MDQMS-2023-07) can be found on SAC's official website.
Kindly note that applications falling within the scopes currently under application cannot be accepted at this time.
Should you have any inquiries about certification or seek further information about BSI Singapore Certification, don’t hesitate to reach out to us at info.sg@bsigroup.com. Kindly specify “SAC ISO 13485” in the subject of your email.
Yours sincerely,
Graeme Tunbridge
SVP Global Regulatory and Quality
Regulatory Services, BSI
