• 2024-06-20 05:49:36

In a significant step towards regional harmonization, the Hong Kong MDD announced on 2 April 2024, that they now recognize marketing approvals for Class II, III, and IV medical devices issued by Singapore's Health Sciences Authority (HSA) This means manufacturers with existing HSA approvals can now use them to support their applications for registration in Hong Kong, potentially saving significant time and resources.

• 2021-08-30 01:11:33

The Medical Device Division (MDD) 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” by providing marketing approval from China's National Medical Products Administration (NMPA) and Korea's Ministry of Food and Drug Safety (MFDS).

• 2021-05-22 04:28:32

On April 20, 2021, Malaysia Medical Device Authority (MDA) published a revision list of Medical Device-Drug-Cosmetic Interphase (MDDCI) products. MDA has classified they regulated medical device and combination products that primary intended use of the device and the primary mode of action is to be used as a medical device.

• 2020-05-06 05:18:20

The draft guidance on labeling is catered to provide a comprehensive information on medical device and IVD use among patients and/or end-users. The Guidance is expected to take effect after 15 days following its official publication.

• 2020-02-13 06:02:57

It has been earlier established that Medical Device Authority (MDA) and National Pharmaceutical Regulatory Agency (NPRA) of Malaysia will start to regulate drug-medical device and medical device-drug combination products together, starting July 1st, 2019.