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Thailand: New Registration Flow and Criteria for Supplements in Thailand

Leave a Comment / Regulatory updates, Thailand / By Kia UP

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 of documents according to the […]

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

Leave a Comment / Malaysia, Regulatory updates / By Kia UP

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 (Interpol) with the involvement of

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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

Leave a Comment / Regulatory updates, Vietnam / By Kia UP

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 prevention and control in emergency

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 Read More »

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

Leave a Comment / Regulatory updates, Vietnam / By Kia UP

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 assessment by the competent authority

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 Read More »

Indonesia: Substitution of Imported Medical Devices with Domestic Medical Devices in the sectoral e-Catalogue

Leave a Comment / Indonesia, Regulatory updates / By Kia UP

Indonesia’s government through the Ministry of Health continues to support the usage of locally manufactured medical devices, especially the ones purchased via e-Catalogue by national hospitals. This campaign is stated under Instruction President No. 2-year 2022, which instructs the Ministry of Health to update the policies in accelerating and increasing the use of locally manufactured

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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

Indonesia: Substitution of Imported Medical Devices with Domestic Medical Devices in the sectoral e-Catalogue

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