September 2022

Monkeypox IVD test

Guideline for Registration of Orthopoxvirus (Monkeypox) IVD Test Kits by MDA

MDA has released a new guideline document for the registration of Orthopoxvirus (Monkeypox) IVD Test Kits, entitled “Guideline for Registration of Orthopoxvirus (Monkeypox) IVD Test Kits” (MDA/GL/09), First Edition” dated September 2022. The guidance document entails the registration requirements, registration process flow, classification, evaluation timeline, application and registration fees of Orthopoxvirus (Monkeypox) IVD Test Kits. …

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Pharmacists in chemist

Guidelines on the Use of the Food and Drug Administration e-Services Portal System for License to Operate (LTO) Application of Retailers of Medical Devices

On September 9, 2022, the Philippines FDA issued FDA Circular No 2022-007 that provides guidelines on the use of the FDA e-Services Portal System for the LTO Application of Medical Device Retailers. The FDA e-Services Portal System has been developed and updated to provide a streamlined online platform for FDA Authorization applications to include LTO …

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75% Alcohol swabs

Transfer of Product Registration of Alcohol Swab with 70% Isopropyl Alcohol from Centre for Device Regulation, Radiation, Health, and Research (CDRRHR) to Centre for Drug Regulation Research (CDRR)

On September 6 2022, The Philippines FDA issued FDA Advisory No. 2022-1576 to transfer the product registration of alcohol swab with 70% isopropyl alcohol from the CDRRHR to the CDRR. Alcohol swab with minimum concentration of 70% isopropyl alcohol are within the jurisdiction of the CDRR under Household Remedy Products. With the issuance of FDA …

Transfer of Product Registration of Alcohol Swab with 70% Isopropyl Alcohol from Centre for Device Regulation, Radiation, Health, and Research (CDRRHR) to Centre for Drug Regulation Research (CDRR) Read More »

New compliance rules

MDA Released Two New Guidance Documents on Harmonized Risk Classification of Medical Devices and Borderline Products in ASEAN

On September 5th 2022, the MDA released two First Edition Guidance Document: “Harmonized Classification of Medical Devices In ASEAN” (MDA/GD/0062) and the First Edition Guidance Document: “Harmonized Borderline Products in ASEAN” (MDA/GD/0063). These guidance documents are mostly concerned with: Harmonized list of risk classification of medical devices including in-vitro diagnostic (IVD) medical devices based on …

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Exhibition with delegates visiting booths

Minor Update To Guidance For Importation Of Unregistered Medical Devices For Exhibition In Singapore

The Health Sciences Authority (HSA) Singapore published a minor update to guidance document, GN-32 GUIDANCE FOR IMPORTATION OF UNREGISTERED MEDICAL DEVICES FOR EXHIBITION IN SINGAPORE Rev 5. This update is to inform exhibitors intending to import unregistered medical devices for exhibition to submit the Form 32: Application for Importation of Unregistered Medical Devices for Exhibition, …

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