Regulatory updates Archives

Philippines: The Philippines FDA Amended FDA Circular No. 2021-025 Entitled, “Guidelines for Application of Authorizations at the Food and Drug Administration in Light of the Extended State of Public Health Emergency”

October 10, 2022

The Philippines FDA Amended FDA Circular No. 2021-025 Entitled, “Guidelines For Application Of Authorizations At The Food And Drug Administration In Light Of The Extended State Of Public Health Emergency” The Philippines FDA Amended FDA Circular No. 2021-025 Entitled, “Guidelines For Application Of Authorizations At The Food And Drug Administration

Malaysia: MDA Issued Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027)

October 2, 2022

On September 23 2022, the MDA has announced the release of the Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027). This guidance document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737)

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

September 29, 2022

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

Philippines: 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

September 14, 2022

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

Philippines: 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)

September 14, 2022

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.

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

September 12, 2022

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

Regulatory Updates

Philippines: The Philippines FDA Amended FDA Circular No. 2021-025 Entitled, “Guidelines for Application of Authorizations at the Food and Drug Administration in Light of the Extended State of Public Health Emergency”

Malaysia: MDA Issued Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027)

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

Philippines: 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

Philippines: 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)

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

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Regulatory Updates

Philippines: The Philippines FDA Amended FDA Circular No. 2021-025 Entitled, “Guidelines for Application of Authorizations at the Food and Drug Administration in Light of the Extended State of Public Health Emergency”

Malaysia: MDA Issued Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027)

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

Philippines: 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

Philippines: 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)

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

Countries

Categories

Sign up for our regulatory roundup delivered once a month to your inbox

Main Pages

Address

E-mail Address

Phone Number

Main Pages

Address

E-mail Address

Phone Number

Stay Ahead in Southeast Asia's Medical Device Market!

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