Regulatory updates Archives

Vietnam: Vietnam’s Ministry of Health and Ministry of Finance issues New Circular Regulations that benefits Medical Device Industry and Draft Regulation pertaining to exporting and importing MD with HS Code

August 16, 2023

The Ministry of Health of Vietnam issued several new regulations that took effect from July 1st, 2023. The following is the summary of how the regulations may have affected the provision of medical devices in the Vietnamese Market. Circular No. 14/2023/TT-BYT stipulated the order and procedures for formulating bidding packages

Singapore: Fifth Revision of Singapore’s Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices

August 14, 2023

The Health Sciences Authority of Singapore (HSA) has revised the GN-02: Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices as of 31 July 2023. This guidance will be applicable to any entity who performs manufacturing, importing, and supplying by wholesale of the medical devices. The following are

Malaysia: MDA Invites for Public Feedback on draft of First Edition Guidance Importation of Medical Device for Personal Use

August 14, 2023

Medical Device Authority (MDA) has released a draft guidance document titled ‘Importation of Medical Device for Personal Use’ for public review and feedback. The guidance document will be applicable to all home use medical devices that fall within the definition of a medical device, as defined in MDA/GD/0006: Definition of

Indonesia: Ministry of Communication and Informatics (Kominfo) proposed changes on the standards for Telecommunication Equipment and/or Equipment Short Distance Telecommunications Devices

August 8, 2023

On 13 July 2023, The Ministry of Communication and Informatics (Kominfo) issued a draft regulation concerning Technical Standards for Telecommunication Equipment and/or Equipment Short Distance Telecommunications Devices. The proposed guidelines will revoke several regulations including SDPPI regulation no 161 Year 2019, the main reference in the registration of Short-Range Devices

Thailand: Thai FDA released a draft Ministry of Public Health Announcement on the Quality System to Produce Medical Devices B.E.

August 7, 2023

In the interest of consumer protection and to ensure the quality, efficiency, and safety of medical device production, the Thai FDA released a draft public health announcement and guideline to establish a quality system for producing medical devices on 19 July 2023. Should the final announcement and guideline be approved

Thailand: Thai FDA released a draft Ministerial Announcement on the Quality Management System for Importing or Selling Medical Devices, B.E.

August 7, 2023

In the interest of consumer protection and to ensure the standardized quality, efficiency, and safety of importing or selling medical devices, the Thai FDA released a draft announcement and guideline on the Quality Management Systems for Importing and Selling Medical Devices on 19 July 2023. Should the final announcement/guideline be

Regulatory Updates

Regulatory Updates

Vietnam: Vietnam’s Ministry of Health and Ministry of Finance issues New Circular Regulations that benefits Medical Device Industry and Draft Regulation pertaining to exporting and importing MD with HS Code

Singapore: Fifth Revision of Singapore’s Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices

Malaysia: MDA Invites for Public Feedback on draft of First Edition Guidance Importation of Medical Device for Personal Use

Indonesia: Ministry of Communication and Informatics (Kominfo) proposed changes on the standards for Telecommunication Equipment and/or Equipment Short Distance Telecommunications Devices

Thailand: Thai FDA released a draft Ministry of Public Health Announcement on the Quality System to Produce Medical Devices B.E.

Thailand: Thai FDA released a draft Ministerial Announcement on the Quality Management System for Importing or Selling Medical Devices, B.E.

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Regulatory Updates

Regulatory Updates

Vietnam: Vietnam’s Ministry of Health and Ministry of Finance issues New Circular Regulations that benefits Medical Device Industry and Draft Regulation pertaining to exporting and importing MD with HS Code

Singapore: Fifth Revision of Singapore’s Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices

Malaysia: MDA Invites for Public Feedback on draft of First Edition Guidance Importation of Medical Device for Personal Use

Indonesia: Ministry of Communication and Informatics (Kominfo) proposed changes on the standards for Telecommunication Equipment and/or Equipment Short Distance Telecommunications Devices

Thailand: Thai FDA released a draft Ministry of Public Health Announcement on the Quality System to Produce Medical Devices B.E.

Thailand: Thai FDA released a draft Ministerial Announcement on the Quality Management System for Importing or Selling Medical Devices, B.E.

Countries

Categories

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

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Main Pages

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E-mail Address

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