News

THAILAND: Food and Drug Administration Announcement Regarding the Document Preparation for Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device Manufacturing / Import License Renewal – October, 2020

THAILAND: Food and Drug Administration Announcement Regarding the Document Preparation for Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device Manufacturing / Import License Renewal – October, 2020

  • 2020-10-19 09:48:24

Food and Drug Administration has announced sets of documentation required for Licensed Medical Device Manufacturing / Import License Renewal and Notified Medical Device Manufacturing / Import License Renewal that will expire in December 31st, 2020.

More
USA: New Exemption List for Class II Products – September, 2020

USA: New Exemption List for Class II Products – September, 2020

  • 2020-09-15 09:09:58

After a lengthy discussion, the U.S. Food and Drug Administration (FDA) released the final determination of the exempt list for the premarket notification (510 k). The exemption list is immediately in effect after July 22nd, 2020. We summarize the Agency's final determination information from the FDA for you.

More
THAILAND: Ministry of Public Health Announces Medical Device Definitions that Manufacturer and Importer Must Proceed Medical Device to be Notified Registration – September, 2020

THAILAND: Ministry of Public Health Announces Medical Device Definitions that Manufacturer and Importer Must Proceed Medical Device to be Notified Registration – September, 2020

  • 2020-09-15 08:44:25

Thailand’s Ministry of Public Health has announced a set of medical device definition for manufacturers and importers to follow when registering their medical device according to risk-based classification, to gradually endorse the transition of Thailand away from policy-based classification.

More