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INDONESIA:  New Guidance on Procedures for Withdrawal and Destruction of Non-conforming Medical Devices – July, 2021

INDONESIA: New Guidance on Procedures for Withdrawal and Destruction of Non-conforming Medical Devices – July, 2021

  • 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.

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INDONESIA: Further Validation Test Needed for Some Approved Rapid Diagnostic Tests of Antigen Covid-19 in Indonesia – June, 2021

INDONESIA: Further Validation Test Needed for Some Approved Rapid Diagnostic Tests of Antigen Covid-19 in Indonesia – June, 2021

  • 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.

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INDONESIA: Government Regulation No. 39/2021 regarding Halal Product Implementation is released – May, 2021

INDONESIA: Government Regulation No. 39/2021 regarding Halal Product Implementation is released – May, 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.

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INDONESIA: Further Validation Test Needed for Some Approved Rapid Diagnostic Tests of Antigen Covid-19 in Indonesia

INDONESIA: Further Validation Test Needed for Some Approved Rapid Diagnostic Tests of Antigen Covid-19 in Indonesia

  • 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.

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INDONESIA: Vaccine and Pharmaceutical (medical) Storage / Refrigerator No Longer Considered as Medical Devices

INDONESIA: Vaccine and Pharmaceutical (medical) Storage / Refrigerator No Longer Considered as Medical Devices

  • 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.

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