• 2021-06-25 12:32:37

While the channel of distribution of a COVID-19 vaccine under the conditional approval scheme is rigorously controlled by the Thai FDA, a fast-track approval route was launched exclusively for more COVID-19 products even under the implementation of risk-classification regulation.

• 2021-05-22 07:03:29

As TFDA's Medical Device Act has come into force on May 1st, 2021, supporting measures and announcements following the Act have sprung up like mushrooms recently. This article provides a quick guide and introduction to each corresponding measure.

• 2021-05-22 04:20:30

PFDA shared the updated procedure for the issuance of special certification for COVID-19 test kits following recent guidance for minimum performance requirements of different types of COVID-19 Test Kits.

• 2021-05-22 03:37:21

The US Food and Drug Administration (FDA) has published a new policy in the Federal Register, to modify identifications of medical software in classification regulations. There are some software functions that would no longer be regulated by the FDA. The new policy is effective immediately from the date of publication.

• 2021-05-22 03:30:32

In line with the risk classification transition, the Thai FDA has withdrawn the Ministry of Public Health’s exemption notice on surgical gowns, isolation gowns/coverall, disposable surgical masks, and disposable surgical masks N95, under Special Registration Route. Manufacturers must now apply the procedure according to the recently released risk-based classification requirements consistent with the ASEAN MDD.

• 2021-05-22 03:15:45

Thai FDA has publicized a series of regulations for Listing Medical Device (Class 1), fulfilling the completion of the transition from policy-based classification to risk-based classification. This marked a milestone for both establishments and the Thai FDA team.

• 2021-04-20 03:47:45

The major impacts to TFDA's medical device regulations and fees are brought to you by Qualtech.

• 2021-03-22 06:21:15

After seeking for public and specialist opinions for a while. Finally, Thai FDA has announced the official-related announcements regarding a transition from policy-based classification to risk-based classification of medical devices.

• 2021-03-22 02:12:12

In the light of the continuing COVID-19 pandemic, PFDA announced FDA Circular 2020-024-A which extended the validity of Licences to Operate (LTOs) and Certificates of Product Registration/Notification (CPR/Ns) that are expiring from 01 January to 30 June 2021. In addition, PFDA released key documents/announcements affecting medical device transactions to PFDA

• 2021-02-22 01:59:49

Recently, PFDA has shared two key guidance to the industry and stakeholders. FDAC 2020-001A updates the list of registrable medical devices while FDAC 2021-002 discusses the full implementation of medical device registration as per AO 2018-0002. The new guidance will have immediate impact the regulatory requirement for medical devices prior importing and selling in Philippines.