• 2021-08-01 16:18:48

The Ministry of Finance has issued a new regulation on Tariffs for the Public Service Halal Products Certification Agency at the Ministry of Religion. It regulates the price range for halal certification that will be applied to goods circulated in Indonesia such as medical devices containing animal derivatives.

• 2021-08-01 16:05:20

The Indonesian Ministry of Health has issued new guidance on Withdrawal and Destruction of Non- Conformity Medical Devices. It describes the types, criteria, roles and responsibilities, classifications, and procedures for withdrawing medical devices from circulation. It is hoped to assist manufacturers, importers, and distributors in better managing post-market activities such as the withdrawal of medical devices in Indonesia.

• 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.

• 2021-05-22 06:38:30

The Indonesian government has issued regulation no. 39/2021 concerning the implementation of the halal product assurance sector. This will make medical devices containing animal derivatives expected to have halal certification with the following timeline: Class A is enforced starting on 17 October 2026, Class B is on 17 October 2029, and Class C is on 17 October 2034. While for Class D the implementation date hasn't been decided yet.

• 2021-05-22 05:31:34

The Indonesian Ministry of Health has issued guidance on reporting of Adverse Events (in Indonesia: Kejadian Tidak Diinginkan/ KTD). The guidance book explains the types of adverse events (KTD) that must be reported to the Ministry of Health and the reporting period.

• 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.