Singapore HSA Updates GN-06: Guidance on Distribution Records for Medical Devices
HSA has included “ISO 13485:2016” in defining the projected useful life of a medical device. Product owners may refer to …
Singapore HSA Updates Medical Device Guidance GN-20: Guidance on Clinical Evaluation
HSA has specified “ISO 14155 – Clinical Investigation of Medical Devices for Human Subjects” in GN-20: Guidance on Clinical Evaluation, …
Singapore HSA Publishes New Regulatory Guidelines for Laboratory Developed Tests (LDTs)
Laboratory Developed Tests (LDTs) are in vitro diagnostic tests (IVDs) that are: • developed and manufactured within a licensed clinical …
Philippines FDA Publishes Circular on The Abridged Processing of Medical Devices Registration With Approval by The NRA of Any ASEAN Member Country
Philippines FDA issues Circular No. 2022-008 on 27th September 2022, aims to provide guidelines on the abridged processing of applications …
China NMPA Extends Drug Submission Time for Supplementing Materials
On October 14th, China’s National Medical Products Administration (NMPA) announced an extra 80 to 160 days extension for the submission …
Hong Kong DOH Updates the List of Refence Countries for Registration of Pharmaceutical Products
Hong Kong’s Pharmacy and Poisons Board reviewed the requirements of the list of reference countries for the registration of pharmaceutical …
Thailand FDA Implements GMP Clearance Temporary Process During COVID-19 Pandemic
The State Drug Regulatory Authorities overseas, responsible for the assessment of manufacturing standards according to GMP principle, have postponed the …
Singapore HSA to Commence Phase 1 Implementation of Unique Device Identification (UDI) System
From 1st November 2022, all medical devices under the closed list of high-risk implantable published in HSA’s guidance document GN-36: …
Vietnam Ministry of Health Updates Guidance Report of Bioavailability/Bioequivalence for Drug Registration
This Circular is issued on 5 Sept 2022, effective on 1 Nov 2022, and replaced the current guideline Circular 08-2010/TT-BYT …