August 2023

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Singapore: HSA Updated Medical Device Product Registration Guidance Documents and Related Templates

The Health Sciences Authority (HSA) of Singapore has revised guidance documents and templates pertaining to medical device product registrations. The key updates are as follows: Apart from requirements of registration under Health Products Act, local supply and use must comply with other legislations such as Private Hospitals and Medical Clinics Act, Healthcare Services Act, Professional […]

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Malaysia’s Medical Devices Market: US$3.27B Projected Revenue in 2023!

The medical devices market in Malaysia is poised for significant growth, driven by advancements in healthcare infrastructure and increasing healthcare expenditure. With a projected revenue of US$3.27 billion in 2023, the industry is witnessing a dynamic shift, attracting attention from both local and international players. Cardiology Devices Leading the Market Among the various segments within

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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

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 for procurement of goods and

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 Read More »

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

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 the highlights of the guidance

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

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 Medical Device, including in vitro

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

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 (SRD). This SRD technologies includes

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

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 and released, effectivity would be

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

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 approved and released, effectivity would

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

Indonesia’s Halal Regulation Update

On 27 June 2023, the Ministry of Health (MoH) of Indonesia invited relevant stakeholders to gather input on the Draft Guidelines for Halal Manufacturing Practices for Drugs, Biological Products, and Medical Devices, as well as the Inclusion of Information on the Origin of Ingredients for Medical Devices. Andaman Medical Indonesia was amongst those who were

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Indonesia: e-Catalogue Opening Submission for Maintenance and Repair Services for Healthcare Facilities

On 20 July 2023, the Ministry of Health (MoH) Indonesia invited stakeholders to a Socialization of e-Catalogue Opening Submission for Maintenance and Repair Services for Healthcare Facilities via Zoom meeting. Indonesia MoH Bureau of Procurement of Goods and Services announced the opening submission for maintenance and repair services for Healthcare Facilities and share the requirements

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