MALAYSIA: New Medical Device Database: Medical Device Authority Register (MDAR)
- 2020-12-23 02:21:33
MDA has announced a new search database, Medical Device Authority Register (MDAR).
MoreMDA has announced a new search database, Medical Device Authority Register (MDAR).
MoreMDA has come up with a new guidance document incorporating the 2019 published Medical Device Advertisement Regulation.
MoreWith Overseas Medical Equipment Technical Assistants (OMETA), Qualteh has held an online seminar about regulatory updates in ASEAN on 27th October, where we covered major updates in the Philippines, Thailand, and Malaysia.
MoreMalaysia Medical Device Authority (MDA) published a new circular letter on the policy implementation and enforcement for the refurbishment of medical device and effective immediately. The policy decision to ensure the safety and effectiveness of the refurbished medical devices itself.
MoreMDA has recently announced that it will no longer consider Notification of Special Access (Route A) applications to manage COVID-19 medical device shortage in the country.
MoreVentilators are recently allowed to be imported into the country under special access route, in light of THE COVID-19 emergency. Now, MDA has specified requirements to be followed for this special situation, to mitigate the risks that may follow.
MoreA new guidance document on this has been issued with the requirements to be followed: All orphaned, obsolete and discontinued medical device still in active use must now be notified with MDA.
MoreMalaysia makes efforts to keep the Covid-19 outbreak contained in the country. Medical Device Authority issued a few more important advisories.
MoreIn a latest announcement, MDA has announced that unregistered face masks shall henceforth be placed in the market via a Special Access route.
MoreEarlier in January 2020, MDA had released a revised Circular Letter No. 2 Year 2018, on the control of orphaned, obsolete and discontinued medical device healthcare and related facilities. There have been some revisions introduced to the definition of types of medical devices covered in this circular letter.
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