Regulatory updates Archives

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

Exhibition with delegates visiting booths

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

September 9, 2022

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

Thailand: New Registration Flow and Criteria for Supplements in Thailand

August 25, 2022

The Medical Device Control Division, Thai Food and Drug Administration (Thai FDA) of the Ministry of Public Health issued an announcement on the new registration flow and criteria for the supplements effective from 1 August 2022. It involves 2 (two) steps as follows: Step 1: Screening to check the completeness

Malaysia: Enforcement Activities Carried Out By The MDA During The Participation In The Pangea XV 2022 Operation

August 24, 2022

The Medical Devices Authority (MDA) has joined Operation Pangea XV from June 22 to July 05, 2022, which is a worldwide campaign operation to carry out large-scale enforcement actions against the sale of counterfeit and illicit medicines and medical products. This operation is coordinated by the International Criminal Police Organization

Laboratory technician processing PCR C*vid-19 tests

Vietnam: Ministry of Health issues Circular No. 06/2022/TT-BYT: List and issuance of registration numbers of medical devices intended for COVID-19 pandemic prevention and control in emergency cases

August 12, 2022

With the emergence of COVID-19 pandemic, the Ministry of Health is continuing its effort to control the epidemic by adjusting its regulations. On August 1, 2022, the Ministry of Health has issued Circular No. 06/2022/TT-BYT defining the list and issuance of registration numbers of medical devices intended for COVID-19 pandemic

Doctor in hazmat ppe checkin patients temperature

Vietnam: Ministry of Health issues Circular 05/2022/TT-BYT: Regulating in detail the implementation of some articles of Decree 98/2021/ND-CP on Management of Medical Devices

August 10, 2022

On August 1, 2022, the Vietnamese Ministry of Health issued Circular 05/2022/TT-BYT, regulating in detail the implementation of some articles of Decree 98/2021/ND-CP on Management of Medical Devices. This circular contains the following details: A. Supplement the list of in vitro diagnostic medical device that is not subject to quality

Regulatory Updates

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

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

Thailand: New Registration Flow and Criteria for Supplements in Thailand

Malaysia: Enforcement Activities Carried Out By The MDA During The Participation In The Pangea XV 2022 Operation

Vietnam: Ministry of Health issues Circular No. 06/2022/TT-BYT: List and issuance of registration numbers of medical devices intended for COVID-19 pandemic prevention and control in emergency cases

Vietnam: Ministry of Health issues Circular 05/2022/TT-BYT: Regulating in detail the implementation of some articles of Decree 98/2021/ND-CP on Management of Medical Devices

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