HSA has included “ISO 13485:2016” in defining the projected useful life of a medical device.
Product owners may refer to ISO 13485:2016 – Medical devices – A practical guide, for some
read more...HSA has included “ISO 13485:2016” in defining the projected useful life of a medical device.
Product owners may refer to ISO 13485:2016 – Medical devices – A practical guide, for some
read more...HSA has specified “ISO 14155 – Clinical Investigation of Medical Devices for Human Subjects” in GN-20: Guidance on Clinical Evaluation, as a benchmark to the industry that clinical investigations are
read more...Laboratory Developed Tests (LDTs) are in vitro diagnostic tests (IVDs) that are:
• developed and manufactured within a licensed clinical laboratory and solely for use within the same laboratory where it
Philippines FDA issues Circular No. 2022-008 on 27th September 2022, aims to provide guidelines on the abridged processing of applications for registration of medical devices with product approval issued by
read more...On October 14th, China’s National Medical Products Administration (NMPA) announced an extra 80 to 160 days extension for the submission of drug supplementary dossiers to China’s Center for Drug Evaluation
read more...Hong Kong’s Pharmacy and Poisons Board reviewed the requirements of the list of reference countries for the registration of pharmaceutical products containing new chemical or biological entity (NCE).
Effective 1st November
read more...The State Drug Regulatory Authorities overseas, responsible for the assessment of manufacturing standards according to GMP principle, have postponed the assessment of manufacturers located inside and outside the authority’s country
read more...From 1st November 2022, all medical devices under the closed list of high-risk implantable published in HSA’s guidance document GN-36: Guidance on Medical Device UDI System, that are to be
read more...This Circular is issued on 5 Sept 2022, effective on 1 Nov 2022, and replaced the current guideline Circular 08-2010/TT-BYT dated 26 Apr 2010. Vietnam Ministry of Health stipulates in
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