• 2020-06-11 10:06:42

PFDA issues FDA Circular No. 2020-016 to remind public that online sale of approved COVID-19 test kits is prohibited. Furthermore, the kits are for medical professional use only. PFDA urges law enforcement as well as the public to be vigilant regarding COVID-19 test kits in the market.

• 2020-06-11 10:00:48

Health Sciences Authority (HSA) is informed to the increased demands for medical products relevant to COVID – 19. Various establishments have considered 3D printing (3 – DP) to address the issue of limited supply of medical products.

• 2020-06-11 09:53:23

Health Sciences Authority (HSA) strengthens surveillance on different selling platforms to monitor health products with misleading claims to prevent, treat or diagnose COVID-19.; Warnings Issued to Over 1,600 Individual Sellers and Companies. HSA also urges public to be vigilant to report these products.

• 2020-06-11 09:48:40

NMPA publishes a clear guidance to regulate the raw material change in medical device. In this guidance, it points out three major changes on material component and how to perform the risk assessment on raw material change.

• 2020-06-11 09:41:54

NMPA drafts a new guidance document of human factors (Usability) for medical device, the Class II and Class III devices are applicable once implementation. Now NMPA seeks for public comment.

• 2020-06-11 09:36:28

A new online submission system has been implemented for one year, and NMPA notifies that the agents should renew the CA as soon as possible to ensure the certificate validity.

• 0000-00-00 00:00:00

Despite the effect of COVID-19 outbreak, ThaiFDA continued to perform at its best for the Medical device regulation reform update. Future regulation follows Risk- based Classification, while current regulation follows Policy- based Classification. Thai FDA Announced that Manufacturer and Importer must Proceed Medical Device to be Licensed Registration.

• 2020-05-14 09:43:07

The online event represents the second webinar in our 2020 series and will be held on June 17th, 2020 (Wednesday) at 11am (GMT+8). Shall this Webinar be of interest to you or one of your colleagues, please be sure to register under the following link (limited seats available).

• 2020-05-12 08:23:22

PFDA reminds the public to buy health products, including medical devices and supplies, only from online sellers with proper authorization/s. In a separate announcement, PFDA released a guidance for manufacturers of PPEs, ventilators and respirators during the COVID-19 pandemic.

• 2020-05-12 08:21:54

Ventilators are recently allowed to be imported into the country under special access route, in light of THE COVID-19 emergency. Now, MDA has specified requirements to be followed for this special situation, to mitigate the risks that may follow.