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
Regulatory News
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 for registration of medical devices with product approval issued by
read more...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 of drug supplementary dossiers to China’s Center for Drug Evaluation
read more...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 products containing new chemical or biological entity (NCE).
Effective 1st November
read more...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 assessment of manufacturers located inside and outside the authority’s country
read more...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: Guidance on Medical Device UDI System, that are to be
read more...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 dated 26 Apr 2010. Vietnam Ministry of Health stipulates in
read more...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 on 20 Oct 2022, replacing the current guideline Circular 32/2018/TT-BYT
read more...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 involving medical devices in ASEAN countries in August 2022.
Annex A
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