• 2024-10-10 08:07:48

The FDA launched the Voluntary Malfunction Summary Reporting (VMSR) program in 2018 to streamline the malfunction reporting process for medical device manufacturers. This initiative enhances the FDA's capacity to effectively monitor a diverse array of devices.

• 2024-09-17 02:22:43

The Thai FDA has announced significant regulatory changes to accelerate the approval process for medical device manufacturing and importation. Effective June 6, 2024, these changes aim to reduce redundancy in documentation without compromising product safety or quality. This streamlined approach is expected to foster innovation, attract foreign investment, and enhance Thailand's position as a regional healthcare hub.

• 2023-12-26 02:01:02

FDA is issuing a guidance in relation to Section 506J of Federal Food, Drug, and Cosmetic Act. In which manufacturers are required to promptly notify the FDA, whether during or prior to a Public Health Emergency (PHE), of any permanent discontinuance or interruption in the production of specific devices.

• 2023-10-20 06:31:20

Recently, TFDA has announced an amendment to the classifications of medical devices. The scopes and identifications of several medical device classifications have been updated to provide more specific and clearer instructions. Among these, the risk level of 3 classifications has been re-determined and there are 11 new additional classifications.

• 2023-09-27 05:49:24

The FDA has introduced the Customer Relation Management Information System (CRMIS), a digital platform that enables stakeholders and the public to submit inquiries and follow-ups. The system began on August 28, 2023, and will run until November 30, 2023, as part of the FDA's commitment to improving public health services and IT infrastructure.

• 2023-05-24 07:15:51

The applicable expedited route from the Thai FDA supplies much-needed clarity for manufacturers, allowing them to better forecast the potential impact on timelines and costs for certain products. The selection of expedited routes allows applicants to comply according to their medical device approval status.

• 2023-04-24 09:37:45

On March 31, 2023, PFDA has once again extended the application period for one more year for medical device products that were previously considered non-registrable, which currently fall under AMDD risk class B-D. PFDA cites the risk of disrupting the supply chain that may negatively impact the quality of the healthcare system in the country.

• 2023-03-27 08:27:31

Thai FDA announces 'Thailand FDA - WHO Collaborative Registration Procedure (CRP) for in vitro diagnostics (IVDs)', an expedited medical device registration program aimed at reducing the time required for manufacturers and importers to register their products. The program officially commenced on December 28, 2022, onward.

• 2023-03-27 08:22:41

The US FDA starts to launch the so-called "eSTAR" Pilot with Health Canada. The eSTAR is an interactive medical device submission process and is expected to likely become the main path regarding medical device submissions for 510(k) and De novo registrations in the near future.

• 2023-02-23 01:23:58

Thai FDA has published a guidance, which aims to assist the justification status of Software as Medical Device (SaMD) as well as its risk classification for Thai FDA registration.