• 2021-04-26 01:41:13

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.

• 2021-02-22 01:36:27

The Indonesian Ministry of Health has stated that Vaccine and Pharmaceutical (medical) Storage / Refrigerator products are no longer considered medical devices locally. This is stipulated on an announcement on January 19, 2021. Therefore, Vaccine and Pharmaceutical (medical) Storage / Refrigerator can be freely sold in Indonesia without getting Medical Device Marketing Authorization Certificate from MoH.

• 2021-01-19 03:20:16

Indonesia's Ministry of Health has explained about the scenario of "Double Agent" at a seminar that was held recently. "Double Agent" is the term used to refer multiple authorizations for the one product brand originated from the same Principal or Manufacturer to the several Medical Device Distributors.

• 2020-11-26 03:47:29

In 2020, National Public Procurement Agency (in Indonesia known as LKPP) has opened E-katalog registration for domestic medical device products and several medical products for handling Covid-19. Due to the Covid-19 pandemic, there are several stages in the E-katalog registration process which is carried out online, namely verification / clarification process. However, the price negotiation stage is still carried out face to face. There is also a possibility that e-katalog registration for imported medical products will be opened around this year.

• 2020-08-11 05:46:22

The Indonesian Ministry of Health has published a guidebook for Grouping of Medical Devices and In Vitro Diagnostic Devices recently. Indonesia has 6 types of grouping, namely: Single, System, Family, IVD Test Kit and IVD System.

• 2020-08-11 05:46:22

The Indonesian Ministry of Health has issued a guidebook, which will be explained the flow of medical device services specifically for medical and household health supplies used for handling Covid-19.

• 2020-06-16 07:02:42

COVID-19 outbreak causes the need for medical devices to be in very high demand. Therefore, IAPI (Association of Indonesian Procurement Experts) together with PERSI (Association of Hospitals throughout Indonesia) has provided an emergency medical equipment information system to handle the procurement and donation throughout Indonesia.

• 2020-06-16 05:58:49

Ministry of Finance Decree ( PMK-34/PMK.04/2020) stated that import of goods for the purposes of handling the COVID-19-related medical products are granted with customs and / or excise and taxation facilities. Applicant could apply the exemption through INSW website (http://www.insw.go.id/). This policy is started from 17 April 2020 until further date set by The National Disaster Mitigation Agency (BNPB).

• 2020-04-14 02:16:06

MOH has stopped enforcing the depkes.go.id domain on all Ministry of Health websites. Thus, will be replaced by the kemkes.go.id domain.

• 2020-03-16 06:38:53

Ministry of Health has issued a Circular letter number HK.02.02 / VI / 1465/2019 about withdrawal and elimination of medical devices that contain mercury from the market. This circular letter is addressed to Head of medical devices manufacturer and Head of medical device distributor in throughout Indonesia. They need to take several actions to help the withdrawal and elimination process of medical devices that contain mercury.