Updates

Singapore: Minor Update on GN-06: Guidance on Distribution Records

In line with GDPMDS, HSA Singapore also published minor updates of guidance document entitled GN-06 R3 Guidance on Distribution Records on 01 Nov 2022 which assist product owners on the determination of projected useful life of the medical device. Projected useful life of a medical device is dependent on various factors such as technical, legal, commercial and etc. Product owners are encouraged to reference ISO 13485:2016 – Medical devices – A practical guide when deciding medical device’ lifetime.

You can read the full amended guideline here.

If you have any queries, please get in touch or click the button below.

Sign up for our regulatory roundup delivered once a month to your inbox



Scroll to Top

Stay Ahead in Southeast Asia's Medical Device Market!

Subscribe to our Newsletter

Be the first to receive essential updates on regulatory changes, market trends, and industry insights from us!

Contact Us