• 2020-09-15 09:26:39

In Vietnam, the fees for processing applications for license to sell and import medical devices will be reduced 30% from July 8th 2020 to December 31th 2020.

• 2020-09-15 09:16:21

PFDA released updated new normal guidelines in relation to PFDA transactions during the quarantine period. These documents will repeal the previously released FDA Circular No. 2020-006 and its amendments.

• 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.

• 2020-09-15 09:06:00

PFDA created a new portal for the Radiation Regulation Division (RRD) which will be utilized for the online transactions for radiation facilities.

• 2020-09-15 08:58:35

Thailand’s Ministry of Public Health has announced the medical devices that are exempted form compliance with certain control measures under Section 6 (18) of the Medical Device Act B.E. 2551.

• 2020-09-15 08:54:58

Ministry of Public Health has made an announcement regarding the Declaration Form for Importer to declare when import all the listed medical device that comply with the standards in 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.

• 2020-09-15 06:53:41

Ministry of Public Health has made 2 additional announcements regarding the Standards of Medical Device that manufacturer or importer must comply to in 2020.

• 2020-09-15 06:44:21

Singapore remains one of the most important medical device hubs in the Asian region, growing to be on par with developed first world nations. With the medical technology industry being one of the major driving forces for the country’s booming economy, in this edition of QT Analysis, we delve deep into the reasons why it is a MedTech Giant in Asia and how you shouldn’t miss out on the great business opportunities it offers.

• 2020-09-15 06:35:40

MDCG has published a guidance for notified bodies on the use of MDASP audit reports in surveillance audit carried out under MDR/IVDR. For those with similar or equivalent requirements, positive QMS conformity result might lead to a reduction of the focus on covered aspect.