• 2024-09-17 05:40:30

NMPA issued a notice that administrative paperwork for some registration matters will become electronic versions starting June 1, 2024.

• 2024-09-17 02:03:36

The Minister of Finance promulgated Circular 43 /2024/TT-BTC dated June 28, 2024, which lowered fees to alleviate difficulties and support production and business activities.

• 2024-07-30 03:35:49

The Medical Device Authority (MDA) announced the applications for medical device re-registration must be submitted online using MeDC@St 2.0+, in accordance with the Guidelines for Re-Registration of Registered Medical Devices (MD/GL/08). One year prior to the certificate expiration date, the system will display a re-registration option enabling the establishments to submit their applications.

• 2024-06-20 06:05:56

Centre for Medical Device Evaluation, NMAP (CMDE) has made an announcement, on adjusting the management of digital certificate (CA certificates), aiming to fulfil the needs of current certificates management.

• 2024-03-01 08:59:50

The CMDE has compiled the medical device registration review guideline catalog published from 2007 to 2023.

• 2023-11-20 01:38:47

The Medical Device Authority (MDA) announced on November 28th that the implementation of a fully electronic medical device registration certificate will start on November 1, 2023. MDA will only issue an electronic registration certificate for applications approved after November 1, 2023.

• 2023-09-27 06:46:28

The Medical Device Authority (MDA) announced transitional period on July 14th for the registration of Covid-19 test kits, which the registration applications would be subjected to the compliance assessment procedure conducted by the compliance assessment body (CAB).

• 2023-09-27 06:13:09

The Philippine Food and Drug Administration (PFDA) released the 2023 edition of the citizen charter, including updates related to the Center for Device, Radiation Health, and Research (CDRRHR).

• 2023-09-27 05:38:54

The Minister of Finance promulgates Circular 44/2023/TT-BTC dated June 29, 2023, and Circular 59/2023/TT-BTC dated August 30, 2023, to adjust administrative fees in the health sector.

• 2023-08-23 06:00:06

The Medical Device Authority's (MDA) approach to expired EC Certificates for New Registration and Re-Registration of Medical Devices has been loosened. In line with Directives 90/385/EEC and 93/42/EEC, MDA recognizes the EC Certificate (CE Marking) as one of the approved types of conformity assessment procedures by way of verification process for the purpose of medical device registration in Malaysia.