February 2024

Andaman Medical Regulatory Affairs Update Philippines

Philippines: PFDA Released Draft Regulation on Extension of Regulatory Flexibility for Non-Registrable Class B, C and D Medical Devices

During the harmonization to ASEAN requirements, PFDA aims to prevent a negative impact on the supply of medical devices by issuing past provisions FC No. 2021-002A, FC No. 2021-002B, and FC No. 2021-002C (valid until Mar 31, 2024) which provide regulatory flexibility to all Class B, C, and D medical devices that are not included […]

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Andaman Medical Regulatory Affairs Update Vietnam

Vietnam: Amendment and Supplementation of Several Articles of Decree 96/2023/NĐ-CP Regarding Medical Device Management

On 30 December 2023, the Authority of Vietnam issued Decree 96/2023/NĐ-CP detailing several articles of the Law on Medical Examination and Treatment. Furthermore, Article 147 of this Decree has amended and supplemented some articles of Decree 98/2021/NĐ-CP regarding “Medical Device Management.” The highlighted amendments and supplementations to the articles of Decree 98/2021/ND-CP are as follows:

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Andaman Medical Regulatory Affairs Update Malaysia

Malaysia: MDA Releases Guidance Document MDA/GD/0067: Enhancing Post Market Information Exchange for ASEAN Member States

The Medical Device Authority (MDA) has released Guidance Document MDA/GD/0067, First Edition, titled “Post Market Information Exchange for ASEAN Member States“, to assist the industry and healthcare professionals in complying with the Medical Device Act (Act 737) and its associated regulations. The development of the Guideline on Medical Device Post Market Information Exchange for ASEAN

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Malaysia: MDA Released Guidance Document MDA/GD/0066: Importation of Medical Device for Personal Use

The Medical Device Authority (MDA) of Malaysia has released Guidance Document MDA/GD/0066, First Edition, titled “Importation of Medical Device for Personal Use”, to support the industry and healthcare professionals in their efforts to comply with the Medical Device Act (Act 737) and its associated regulations. This guidance serves as a comprehensive resource for individuals intending

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Andaman Regulatory Affairs Update Singapore

Singapore: New Revision of the Medical Devices Product Classification Guide

On 24th January 2024, the Health Sciences Authority (HSA) of Singapore issued Revision 10 of the “GN-15 Guidance on Medical Device Product Registration”. The highlighted key update, especially for the evaluation routes of Immediate Class B Registration (IBR condition 1) and Expedited Class C Registration (ECR-1), is as follows: Removal of marketing history in Singapore as

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Regulatory Affairs Update Thailand

Thailand: Draft Guidance on the Temporary Storage of Medical Devices Outside Its Specified Location in the Certificate or License

The Ministry of Public Health (MOPH) of Thailand issued a draft guidance on the Temporary Storage of Medical Devices Outside the Location Specified in the Establishment Registration Certificate, Licenses, Notification Licenses, and Listing Certificates. The key points of the draft guidance are as follows: 1. Storage of medical devices outside its specified location as mentioned

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Andaman Regulatory Affairs Update Thailand

Thailand: Draft for the Announcement of Requirements for Selling of Medical Devices

The Ministry of Public Health (MOPH) issued a draft announcement pertaining to the criterions, procedures, and conditions for selling of medical devices in the Thai market. The following are the key points from the draft announcement: Certain medical devices must only be sold to consumers who have obtained a prescription from a healthcare professional. The

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Regulatory Affairs Update Thailand

Thailand: Draft Announcement for the Production or Sale of Medical Devices Exempted under Section 27 (2) (3) and (4)

The Ministry of Public Health (MOPH) of Thailand issued a draft announcement for the production or sale of medical devices exempted under section 27 (2), (3), and (4), with key points as follows: A. Requirements for production of medical devices for sterilization in hospitals: 1. Sterilization Area: Three designated areas: Dirty Zone (used equipment), Clean

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