Mar 17, 2021

The Medical Devices Branch of Singapore’s Health Sciences Authority (HSA) has announced, in a webinar held on March 2, that it intends to only issue dealer licenses to companies that can provide either 1) a Medical Device Single Audit Program (MDSAP) certificate, or 2) an ISO 13485 certificate from a third-party certification body (CB) accredited by the Singapore Accreditation Council (SAC). The new requirement is to take effect on January 1, 2025.

SAC accreditation for certification bodies issuing ISO 13485 certificates will no longer be voluntary

CBs in Singapore issuing ISO 13485 certificates for local medical device regulatory purposes may currently opt into the SAC accreditation program, and two CBs have already done so. Starting in 2025, accreditation will be required by the HSA instead of being voluntary. The HSA will observe and assess the performance of CBs during audits. It was stated in the webinar that the assessment program will resemble the process already in use for CBs issuing Good Distribution Practice for Medical Devices (GDPMDS) certification.

The HSA intends to provide local medical device dealers (including manufacturers, importers, and wholesalers) with a three-year-long transition period (2022-2024) before the new requirement takes effect. The agency advises dealers to switch to an SAC-accredited CB for recertification if their current CB does not secure accreditation before the next recertification audit taking place during the transition.

The stated purpose of the new requirement is to ensure that ISO 13485 certification in Singapore aligns with international medical device principles. Globally, regulators are moving toward leveraging ISO 13485 certification from equivalent regulators in other countries. More details are provided in the slides accompanying the presentation.

New classification guide will help to determine whether a product constitutes a medical device

The HSA also announced the publication of the draft document, “Medical Devices Product Classification Guide,” which is intended to help determine whether a product is classified as a medical device. The guide focuses on the following product types:

  • products with a medical-related purpose,
  • general purpose products,
  • assistive technology products,
  • products for sports, physical fitness, and general health, and
  • personal protective equipment (PPE).

Consultation for this document will run from March 15 to April 15. Instructions for submitting comments are provided in the announcement.

More information about Singapore HSA medical device regulations from Emergo by UL:

Author

  • Timothy Herr

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