BSI has been awarded ISO 13485 accreditation by SAC

Date: 12 July 2023

In Singapore, local medical devices companies are required to be licensed by the Health Sciences Authority (HSA) to manufacture, import or supply by wholesale. ISO certification represents a pre-requisite to obtain HSA license for manufacturers, importers and wholesalers.

Certification is performed by 3rd party Certification Bodies (CBs) which must be accredited by the Singapore Accreditation Council (SAC) for the following reasons:

  • To ensure consistency and quality in the certification process across various CBs
  • To ensure the ISO13485 certification locally is in line with international medical device regulatory principles

From 1 January 2025, only ISO 13485 issued by SAC accredited Certification Bodies will be accepted for Medical Devices license applications in Singapore.

We are pleased to inform you that on 5 June 2023, BSI was awarded accreditation in the field of Medical Devices Quality Management System - ISO 13485:2016 with Singapore Accreditation Council (SAC). 
The accreditation covers the following scopes:


Main Technical Area(s)

Technical Area(s)

Non-Active Medical Devices

General non-active, non-implantable medical devices

Non-active implants

Devices for wound care

Non-active dental devices and accessories

Non-active medical devices other than specified above

Active Medical Devices (Non-implantable)

General active medical devices

Active (non-implantable) medical devices other than specified above

Active Implantable Medical Devices

General active implantable medical devices

Sterilisation Method for Medical Devices

Ethylene oxide gas sterilization (EOG)

Moist heat

Aseptic processing

Radiation sterilization (e.g., gamma, x-ray, electron beam)

Low temperature steam and formaldehyde sterilization

Thermic sterilization with dry heat

Sterilization with hydrogen peroxide

Sterilization method other than specified above

Parts or Services

Raw materials



Calibration services

Distribution services

Maintenance services

Transportation services

Other services

​​​A list of SAC accredited CBs for MDQMS (i.e., ISO13485) can be found on SAC’s website. This list will be updated upon addition of new accredited CBs. ​​

We encourage you to submit your application as soon as possible to be able to maintain your license with HSA to manufacture, import or supply medical devices in Singapore.

For certification enquiry or further information on BSI Singapore Certification, please visit our dedicated webpage or contact us at

Yours sincerely,
Graeme Tunbridge, BSI SVP Regulatory and Quality
Regulatory Services