FDA PH Issues Guidelines on the Publishing of Package Insert and Patient Information Leaflet of Registered Drug Products in the Food and Drug Administration (FDA) Verification Portal System

Guidelines: A. Approved PI and PIL of all registered drug products shall be published by the FDA in the Verification …

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Singapore HSA Implements GMP Evidence for Drug Substance Manufacturers

As part of a continual regulatory enhancement to ensure the quality standard of therapeutic products supplied in Singapore, Singapore’s Health …

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Singapore HSA Revises Medical Device Adverse Events Reporting Guideline

Singapore HSA revised GN-05: Guidance on the Reporting of Adverse Events for Medical Devices with the following update: – Included …

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Singapore HSA Updates Medical Device Adverse Event Reporting Form

Singapore’s Health Sciences Authority (HSA) updated the Medical Device Adverse Event Reporting Form for Medical Device Dealers (MDAR1 Form). As …

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Singapore HSA Updates Health Supplement & Traditional Medicines Labelling Guideline

HSA updates GUIDELINES FOR LABELLING STANDARDS OF HEALTH SUPPLEMENTS AND TRADITIONAL MEDICINES including clarification on labelling requirements on the name …

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Singapore HSA Accepts MDSAP certification for Medical Device’s QMS Certification

Singapore HSA included Medical Device Singapore Audit Program (MDSAP) certification as one of the acceptable lists of Medical Device’s QMS …

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Singapore HSA Updates Advertisement Guidance for Therapeutic Products

Singapore’s Health Sciences Authority (HSA) updated EXPLANATORY GUIDANCE TO THE HEALTH PRODUCTS (ADVERTISEMENT OF SPECIFIED HEALTH PRODUCTS) REGULATIONS for Therapeutic …

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Singapore HSA Updates Guidance on the Risk Classification of IVD Medical Devices (GN-14)

Singapore’s Health Sciences Authority (HSA) has finalised the updated GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical …

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Malaysia MDA Updates on the Approach to Expired EC Certificate for New Registration and Re-registration of Medical Device

MDA has taken an approach to allow expired EC Certificates to be used for conformity assessment procedures due to the …

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