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).
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JAPAN: PMDA strengthens cooperative relationships with Asian countries – June, 2020
- 2020-06-16 08:03:29
PMDA has announced of organizational restructuring of Office of International Programs, aiming strengthening of cooperative relationship with Asian countries.
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MALAYSIA: MDA has Issued a detailed guidance on handling obsolete and discontinued medical devices – May, 2020
- 2020-05-12 08:20:00
A 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.
More JAPAN: PMDA takes further steps to speed up clinical development of COVID-19 product – May, 2020
- 2020-05-12 08:06:46
In order to tackle the threat of COVID-19, PMDA takes some measures to speed up the development of medical products for COVID-19. Now, timeline for clinical trials are shortened and IRB meeting are allowed to be held in unconventional ways.
More MALAYSIA: MDA issues advisory notices, in light of Covid-19 outbreak - April, 2020
- 2020-04-14 08:36:06
Malaysia makes efforts to keep the Covid-19 outbreak contained in the country. Medical Device Authority issued a few more important advisories.
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HONGKONG: Continuance of trial to accept marketing approval obtained from the Korea MFDS regarding MDACS - April, 2020
- 2020-04-14 01:28:54
The Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP) to prove their medical device conform the “Essential Principles of Safety and Performance of Medical Devices” .
More HONGKONG: Continuance of trial to accept marketing approval obtained from the National Medical Products Administration for listing application of medical devices under the Medical Device Administrative Control System (MDACS) - March, 2020
- 2020-03-16 06:42:41
The Medical Device Division will continue the trial to study the feasibility for Local Responsible Persons (LRP),the trial will last until 31 December 2020 for a limited number of listing applications of Class II/III/IV general medical devices.
More MALAYSIA: MDA allows distribution of unregistered face masks via special notification route – March, 2020
- 2020-03-16 06:31:12
In a latest announcement, MDA has announced that unregistered face masks shall henceforth be placed in the market via a Special Access route.
More MALAYSIA: MDA revised guideline on how to apply for medical device registration under medical device act 2012 (Act 737) – May, 2019
- 2020-05-06 05:10:35
In a recently issued revised guideline on How to Apply for Medical Device Registration Under Medical Device Act 2012 (Act 737), MDA specified that it can drop an ongoing application from MeDC@St system if it exceeds a 90 days stop-clock-time and any new applications which do not conform to requirements specified will be rejected, non-refundable.
More MALAYSIA: Launch of new MDA portal and MDA feedback management system (MDA FEMES) – May, 2019
- 2020-05-06 03:06:32
MDA has launched a new web-portal, replacing the old one and a new Feedback Management System (FEMES). These new web-portal and FEMES system have been introduced to provide better information delivery and take note of customer feedbacks more effectively.
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