• 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.

• 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 06:28:50

PFDA published the list of Value Added Tax (VAT) Exempted Medical Devices affected by the Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act. CREATE Act affects tax and other financial implications for corporations most especially for pharmaceutical and medical device importers, manufacturers, and distributors.

• 2021-09-28 23:56:41

This year, the Philippine Food and Drug Administration (PFDA) has released key registration guidelines that will significantly impact prospective medical device importers/distributors. In this article, we will give you an overview that can serve as your roadmap to navigate these regulatory changes. Read through to know a few other important announcements from PFDA.

• 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.

• 2021-08-02 06:20:55

Consistent with the new guidance published in February 2021 governing the risk- classification, technical documentation requirements, fee schedule and transition plan for medical device registration, respectively announced for medical device manufacturing and importation exemption for certain medical under Medical Device Act 2008 Section 27 (1). The announcement aims to balance medical device distribution brought about by the significant changes in regulation.

• 2021-08-02 06:16:13

Thai FDA progressively issues series of guidelines to enhance the new medical device act. This month will be focusing on the latest requirement on medical device manufacturing, importation, and distribution records or report preparation.