• 2022-09-27 07:58:07

Effective since 6th July 2022, Indonesia's Ministry of Health has issued Ministry of Health Decree number HK.01.07/MENKES/1258/2022 concerning Substitution of Imported Medical Devices with Domestic Medical Devices in the Electronic Catalog / e-Katalog of the Health Sector that implement the freeze/ unfreeze mechanisms.

• 2022-07-26 11:17:42

To make sure vigilance is compiled among related stakeholders, MHLW announced important reminders on hazard prevention measures based on research and surveys conducted.

• 2022-06-29 01:53:45

NMPA has made 3 important announcements on issuing the List of Medical Devices Prohibited from Contract Manufacturing (No. 17 of 2022), the Quality Agreements of Contract Manufacturing Medical Devices (No. 20, 2022), and on Matters Concerning the Implementation of the <Measures for the Supervision and Administration of the Production of Medical Devices> and the <Measures for the Supervision and Administration of the Operation of Medical Devices> (No. 18 of 2022), which have been summarized in our article below.

• 2022-05-26 13:49:52

Screening and inspection of the importation of medical devices are being carried out at the main entry points of malaysia. This is one of the mechanisms to curb the activities of importing medical devices without a valid license, registration or authorization.

• 2021-11-24 09:49:19

With the continuing pandemic, PFDA relaxes its regulation for the manufacture of medical oxygen and the expiry of the special certifications for imported COVID-19 test kits. However, certain conditions must be met to be eligible for these exemption or extension.

• 2021-10-27 07:25:14

Recently, MOH has introduced regulations for a total of seventeen COVID-19-related medical device categories, along with their submission dossiers and routes. Specifically, there are seven selective cases that can applied for fast approval. This circular also includes regulation on Import of medical device in view of COVID-19 prevention for purposes of aid.

• 2021-09-29 02:11:24

MDA wants to advise any organization interested to import and distribute the Covid-19 Self-Test Kit for the Malaysian market to apply through the Conditional Approval Application with MDA.

• 2021-09-29 00:18:14

Thailand’s Ministry of Public Health has recently approved the import permit exemption of 24 additional Sars-CoV-2 (COVID-19) related Medical Device(s), for donation purposes.

• 2021-08-26 12:58:20

In July, MOH released two Official Dispatches as guidance on registration routes and document preparation to import SARS-CoV-2 IVD medical devices and biologicals, especially SASR-CoV-2 Antigen Rapid Test Kit (RTK).

• 2021-08-26 11:57:56

The MDA has published new guidelines for temporary conditional approval for the COVID-19 self-test kit (COVID-19 RTK), which explains the application procedure and requirements that need to be followed by the establishment.