• 2022-03-25 11:56:37

Recently, TFDA has announced an update in the Quality Management System (QMS) application required documents for manufacturers in the US, Puerto Rico, or Guam. Considering the establishment inspection timeline, for manufacturers without EIR within 3 years, audit report issued under MDSAP could be provided instead.

• 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 10:22:35

2021 saw some new regulations being introduced by the TGA, especially on reclassified medical devices, software and increased effort on safe post market vigilance. Let’s take a look at what awaits the Australia medical device regulatory landscape in 2022.

• 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 09:49:19

With the continuing pandemic, PFDA relaxes its regulation for the manufacture of medical oxygen and the expiry of the special certifications for imported COVID-19 test kits. However, certain conditions must be met to be eligible for these exemption or extension.

• 2021-11-24 09:26:58

As we approach the end of the year, Thai FDA published a renewal guideline for licensed and notified medical device manufacturing and importation licenses that will be expired on 31 December 2021. To continue to engage in their respective activities, manufacturers and importers shall comply with this guideline within 1st October to 31st December 2021.

• 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 03:29:49

To increase access examination involved in the diagnosis of SARS infection (COVID -19 Antigen self-test kits), Thai FDA announced to unlock and embrace the online selling of COVID -19 Antigen Self-Test Kits.