• 2023-03-27 08:52:43

PFDA presented a draft of the updated guidelines on obtaining a special permit for restricted use of unregistered drug and medical device products. In addition to previous patient conditions laid out by previous regulations, this new guidance widens the product scope to vaccines and the diseases to include those that may result in the patient's permanent disability.

• 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.

• 2023-02-23 02:05:29

In order to supervise medical device registrants taking the responsibilities for medical device quality and safety, NMPA has issued the so-called "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety".

• 2023-02-23 01:45:57

A pilot run for new requirements on the procurement of medical devices by the Department of Health (DH) will be implemented with effect from 1st October 2022. Under the pilot run, medical devices purchased by Department of Health should preferably be listed under MDACS.

• 2023-02-23 01:35:01

The Medical Device Authority (MDA) published the First Edition Guideline Document “How To Submit An Application For Registration Of A Refurbished Medical Device” (MDA/GL/10) on January 11, 2023. The MDA created this guidance document to assist the industry and healthcare professionals in their efforts to comply with the Medical Device Act (Act 737) and its regulations.

• 2023-02-23 01:28:49

A consultation window for framework and implementation of the Cybersecurity Labelling Scheme for Medical Devices [CLS(MD)] was announced to be open for the public from January 23 to March 3, 2023.

• 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.

• 2023-02-22 11:03:38

According to US FDA's review request for devices, the digital therapy device to reduce sleep disturbance for psychiatric conditions, and the prognostic tests for assessment of liver-related disease progression, will require special control (Class II). Thus, in the future, the US FDA will refer to the class II level to review these two kinds of devices.

• 2023-01-19 06:04:35

The NMPA drafted the <Announcement on the Third Batch of Implementation of the UDI of Medical Devices (Draft for Comment)> and is now soliciting opinions publicly.

• 2023-01-19 01:28:15

As we are easing into the first quarter of 2023, we are thus simultaneously entering into the last phase of Thai FDA grace period regarding the transition to the risk-classification approach. Thus, Thai FDA has published a summary of the medical device categories on their official website instructing medical device registration via Full CSDT submission and Partial 2 Submission route.