Bryan Gilburg - China

“Manufacturers using chemicals included in the list will need to submit annual usage reports to the TFDA.”

Bryan Gilburg

Managing Director

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Sources and Links

The Thai FDA Updates List of Chemical Pollutants

Published on: August 25th, 2021

Manufacturers Will Need to Report Usage of Certain Chemicals

As chemical pollutants become a growing concern, The Thai FDA has released a document to have medical device regulations comply with the Stockholm Convention on Persistent Organic Pollutants. This announcement establishes rules for gathering reports on chemical substances usage, indicated in the chart below. The full announcement can be found here.

If any of these chemicals are used, the amount of usage should be reported to the Thai FDA at mdregulation@fda.moph.go.th beginning September 2021.

CAS No. 335 -67-1 Perfluorooctanoic acid (PFOA
CAS No. 3825-26-1 Ammonium Perfluorooctanoate
CAS No. 334-95-5 Sodium Perfluorooctanoate
CAS No. 2395-00-8 Potassium Perfluorooctanoate
CAS No. 335-93-3 Silver Perfluorooctanoate
CAS No. 335-66-0 Perfluorooctanoyl Fluoride
CAS No. 376-27-2 Methyl Perfluorooctanoate
CAS No. 3108-24-5 Ethyl Perfluorooctanoate

Come Grow with Us

Asia Actual has offices in Bangkok, and throughout Southeast Asia, staffed by experienced, bilingual regulatory and commercial professionals to address any questions or provide support.  Please contact us if you need regulatory support in the region.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.

Blog Posts

China to Implement New Electrical Safety Standards for Medical Devices

An updated China-specific electromedical safety standard (BG 9706.1-2020) that was announced back in February of 2020 will come into full effect on May 1, 2023.

Taiwan FDA Launches New ePortal for Medical Device Applications

The Taiwan FDA has implemented the premarket E-Submission Portal aimed at making it easier for manufacturers to submit their applications

Vietnam’s MOH Holds Conference on Price Declaration

The conference was held to provide clarity to the Price Declaration process and announce the establishment of a new online portal for license holders to declare prices. This comes as many provincial health services, including Ninh Binh and Dak Nong, have not been able to purchase medical products since January 1, 2022.