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 …

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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 …

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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 …

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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 …

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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 …

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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: …

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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 …

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Vietnam Ministry of Health Updates Guideline on Registration of Drug and Medicinal Materials

Circular 08/2022/TT-BYT (Circular stipulating the registration of DRUG, Medicinal materials) was issued on 5th September 2022 and will be implemented …

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MDA Malaysia Releases Information on Harmonised Classification of Medical Devices in ASEAN

The Malaysian Medical Device Authority (MDA) has released the first edition of the guidance document on harmonised classification of regulations …

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