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.
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