• 2024-12-16 05:25:54

The FDA has introduced the Safety and Performance-Based Pathway, offering an alternative route for device clearance by focusing on performance criteria rather than direct comparison to a predicate device. This approach simplifies submissions by emphasizing established safety and performance standards, ensuring effectiveness while reducing regulatory complexities.

• 2024-04-03 09:01:31

Enforced from January 5, 2025, the official gazetting of the 'Good Criteria and Practice for Importing and Selling of Medical Devices 2023', marks a significant milestone in Thailand's medical device regulations.

• 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.

• 2022-12-27 07:40:22

Indonesia Halal Assurance Agency have issued Decree of Head of BPJPH Regulation Number 133 of 2022 concerning Procedures for Requesting Data Amendment on Halal Certificates. This regulation outlines the types of amendment allowed and the procedures for amendment application in Halal certificates.

• 2022-12-27 07:16:43

On November 2nd, Japan's Ministry of Health, Labor and Welfare announced an amendment in the Approval Criteria for dental implants.

• 2021-08-02 06:20:55

Consistent with the new guidance published in February 2021 governing the risk- classification, technical documentation requirements, fee schedule and transition plan for medical device registration, respectively announced for medical device manufacturing and importation exemption for certain medical under Medical Device Act 2008 Section 27 (1). The announcement aims to balance medical device distribution brought about by the significant changes in regulation.

• 2021-08-02 06:08:16

Thai FDA released an update on the criteria, methods, and conditions for Licenses Withdrawal and Failure. This also includes the use of the term Listing to refer to Class I Medical Device.

• 2020-02-21 06:54:34

Changing some information after device approved can be done through amendment which has shorter timeline for approval. However, not all of the changes in the device can apply for amendment. Indonesia Ministry of Health elaborate specific criteria for the type of changes that can be reported as amendment to MoH.

• 2020-07-31 09:31:11

The announcement aims to set a standard and to ensure the direction for the authority in performing an evaluation of HIV screening kit by self-test application.

• 2020-07-31 09:20:55

Thailand FDA is expedient to have amend Announcement regarding the criteria for Full Evaluation and Concise Evaluation dated on October 4, 2019. This amendment aims to be appropriate and consistent with the current situation of the expanding medical device industry.