• 2022-04-27 11:27:43

In correspondence with the risk-classification implementation for recent period starting from mid-February 2021 onwards, Thailand Food and Drug Administration has ultimately publicized the Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device, which has been effective since 1st March 2022.

• 2022-04-27 11:16:17

NMPA has released a series of updated guidelines, which aim to guide registration applicants to prepare for medical device software and AI medical device registration in China. The 3 new guidelines regulate the technical reviewing requirements of medical device software and AI medical devices, while also elaborating on standardizing the cyber-security for medical devices.

• 2022-03-25 11:51:14

Software as Medical Device (SaMD) is rapidly developing and frequently updating its compatible hardware. In order to ensure the safety, performance, and quality of SaMD while keeping in line with international standards, TFDA has released a guideline regarding post-market change application of SaMD.

• 2022-02-18 08:22:55

Indonesia MoH has officially implemented a notification scheme for certain class A medical devices in the REGALKES system since 10th January 2022.

• 2022-02-18 08:10:07

Drug-device combination products that mainly function as medical devices (referred to as drug-device combination medical devices in this guideline) are expected to make prevention and treatment of diseases more effective, but may also lead to new technical concerns. Therefore, NMPA formulated two guiding principles to further guide the applicant's preparation for the registration application for drug-device combination medical devices, and to encourage the innovative development of such products.

• 2021-11-24 09:58:33

In an effort to combat the proliferation of unregistered/unnotified medical device products in various establishments and platforms, PFDA released the guidelines on the licensing of retailers of medical devices in the Philippines.

• 2021-11-24 08:44:32

With the implementation of Risk Classification under the new regulation, Thai FDA agreed to make an amendment to the evaluation expenses. The evaluation fee shall follow the new rates unless the applicant is eligible for a waiver or exemption.

• 2021-11-24 03:19:40

A golden opportunity has opened for manufacturers or importers to shorten the duration of Medical Device Registration of those under Class4 with Thailand FDA and HSA Singapore Regulatory Reliance.

• 2021-10-27 05:47:59

To protect human health and the environment from Persistent Organic Pollutants (POPs), Thai FDA agreed to abide by the Stockholm Convention. In order to establish control measures, they conducted a survey of products/manufacturing processes that utilize perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, and benzyl cyanide.

• 2021-09-29 00:18:14

Thailand’s Ministry of Public Health has recently approved the import permit exemption of 24 additional Sars-CoV-2 (COVID-19) related Medical Device(s), for donation purposes.