• 2020-05-05 08:05:23

HSA requires Class A devices to be listed in SMDR database prior to importation and selling in Singapore. GN-22 includes this list of Class A medical devices of which an item was recently revised by HSA.

• 2020-05-05 07:53:33

HSA introduced evaluation routes to hasten the registration of high-risk devices. GN-15 contains the details of each routes. The latest update for GN-15 (version 7.2) improves the criteria for class B devices to undergo Immediate Class B Registration (IBR) Evaluation Route.

• 2020-05-05 07:40:26

HSA uses post market monitoring in ensuring the safety of medical devices entering the Singapore market. GN-10 guides manufacturers on the steps in reporting hazards to these medical devices. HSA released version 3.5 of GN-10 with minor revisions last January 2019.

• 2020-05-06 05:36:45

Using the available digital technologies, HSA is seeking to improve their Post Market Surveillance mechanism via Field Safety Corrective Action (FSCA) reporting. Last March 2019, has introduced OSCAR, their new Online System which will serve as a one-stop platform for FSCA.

• 2020-05-05 07:10:38

With more and more medical device manufacturers engaging into the AI field, China government has started to draft related guidance document to support these firms in building up feasible regulatory strategic plans for their products employing deep learning technologies.

• 2020-05-05 06:52:56

Due to a number of queries received from manufacturers concerning which category would their products fall under, NMPA has drafted a list of principles which aims to help applicants categorize their antimicrobial-containing medical device products.

• 2020-05-05 06:46:09

NMPA releases the registration approval power to other NMPA branch to enhance the foreign medical device access to China market. This action brings more opportunities for the foreign manufacturers to get product license and enter China market.

• 2020-05-05 06:40:46

MDA has issued a new guidance document on how to bring in special-access devices for specific purposes into Malaysia. MDA defines special access medical device as medical device for the use of medical practitioners in emergency situations or in the event that conventional medical treatment has failed, is unavailable or unsuitable.

• 2020-05-05 06:26:29

MDA has issued a draft guidance document for getting an exemption for export-only medical devices from registration requirement. This draft is open for public comment and the official document is expected to be released soon.

• 2020-05-05 06:04:25

Regarding the implementation of the Digital Signature system which began on 14 February 2019, the Indonesian Ministry of Health determines the format of Labelling Material Design documents uploaded for product registration .