• 2024-05-07 09:28:59

The Medical Device Authority (MDA) announced the cancellation of the Circular exempting the registration of Covid-19 Test Kits from the Compliance Assessment Process by the Compliance Assessment Body (CAB). The MDA Circular No. 1/2022 states the exemption of the compliance assessment process by the Compliance Assessment Body (CAB) under Section 7 of the Medical Devices Act 2012 (Act 737) for the registration of COVID-19 test kits under Section 5 of Act 737 either for self-use or for professional use.

• 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).

• 2023-08-23 05:30:31

Effective July 1, 2023, COVID-19 diagnostic tests for professional use and self-test kits that were previously authorized under the Pandemic Special Access Route (PSAR) should now be registered through full-fledged product registration. In addition, validation requirement documents for each product type for professional use only and self-test kits were also issued by HSA.

• 2023-04-25 01:51:22

The Indonesia Ministry of Health issues circular letter no HK.02.02/E/359/2023 that regulates new requirements for the labelling of Rapid Diagnostic Antigen COVID-19 Nasal Swab Method with Self-Testing Claim.

• 2023-01-19 06:07:49

In order to support the supply of antigen testing reagents for COVID-19, NMPA has made related announcements.

• 2022-02-18 09:04:53

Health Sciences Authority (HSA) issued a list of COVID – 19 test kits that are authorized for professional use. These kits have been given authorization under the Pandemic Special Access Route (PSAR) because Professional Use Only (PUO) kits have been designated as “emergency medical devices”.

• 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.

• 2021-09-29 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.

• 2021-08-26 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.

• 2021-06-25 12:15:56

The Indonesian Ministry of Health announced that Approved Import Rapid Diagnostic Test of Antigen Covid-19 (RDT-Ag) which have not fulfil WHO Emergency Used Listing (EUL) recommendations, US-FDA Emergency Used Authorization (EUA) recommendations, or European Medicine Agency (EMA) recommendations and Approved Local Rapid Diagnostic Test of Antigen Covid-19 (RDT-Ag) which is not tested by Standard of National Institute of Health Research and Development of the Ministry of Health or an independent institution designated by the Ministry of Health are directed to conduct validation tests at laboratories that have been appointed by the Ministry of Health. This is stipulated on an announcement on February 15, 2021.