As part of the larger Post Market Surveillance (PMS) activity in the Philippines, the Food and Drug Administration (FDA) issued a draft on the Guideline for The Recall of Health Products. The main goal of the issuance of this draft guideline is to update the previously issued FDA Circular No.
The Ministry of Public Health (MOPH) of Thailand issued a draft guidance specifying information that should be displayed on a sign at the production, import, or sale site of certain types of medical devices. It is mentioned in the draft guidance that the sign shall include: The name and surname
The Ministry of Public Health (MOPH) in Thailand issued a draft guidance specifying on three types of medical devices that require a production, import, or sale controller, such as: Viscous products for use in eye surgery Silicone breast implants for implantation in the body Hyaluronic acid injections for the correction
To ensure the standardized quality, efficiency, and safety of importing or selling medical devices, which is in the interest of consumer protection, it is appropriate to establish a Quality Management System for Importing or Selling Medical Devices. This announcement shall become effective after 1 year from the date of publication
The Ministry of Public Health (MOPH) in Thailand issued a draft guidance on criterions, procedures, and conditions for the production of medical devices that are exempt under Section 27(8) B.E. 2008. The key points of the draft guidance are as follows: 1. Production of medical devices by a government agency
On 31 December 2023, the Ministry of Health (MoH) of Vietnam temporarily froze the online system for the submission of class C and D medical devices. The DMEC website is currently under maintenance starting 01 January 2024 in order to implement the CSDT in accordance with Decree 07/2023/NĐ-CP amending some articles of
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