ILHAM HIDAYATTULAH

“While the new post-market in-country testing is only advisory, there are benefits to doing so.”

Ilham Hidayattulah
Principal Consultant
Asia Actual Indonesia

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Indonesia to Require Post-Market In-Country Testing of Medical Devices

Published on: October 11th, 2023

Indonesia’s Ministry of Health announced that as of September 22, 2023, certain medical devices will require post-market in-country product testing. While the Ministry of Health explained that initially there is no compulsion to carry out the testing currently, there are rewards for doing so.

Details of In-Country Testing

License holders are expected to carry out local, post-market testing of devices in Indonesia to ensure the products continue to meet defined standards of safety, quality and benefits. This testing is required at least every two years in an accredited testing laboratory and the results must be reported to the Ministry of Health Directorate of Medical Device Supervision electronically.

Benefits of In-Country Testing

Although the new testing requirement will not initially be enforced, there will be benefits to doing so. If a company decides to do in-country testing in Indonesia, the Ministry of Health will list the product on the Supervision Directorate portal and prioritize the product in the e-Katalog (AKA eCatalogue).

Issues with New Testing Rules

Indonesia’s Ministry of Health announced draft guidance on July 21, 2023, that certain medical devices would require post-market testing within Indonesia to ensure products continue to meet safety, quality and benefit requirements independently. They allowed commentary on the announcement through September 22, 2023.

While seeking input on the new regulations for in-country post-market testing, several parties brought up issues with the regulations. For instance, requiring testing every two years in-country will incur greater costs for license holders and/or manufacturers. Furthermore, many manufacturers are of the opinion that this testing should be performed by local authorities and not be a burden to the license holder.

Additionally, many distributors do not have stock in inventory to carry out testing of certain large products, such as CT scanners. Even if the manufacturer does have the required inventory, the tested products are likely to be considered “used goods”, which means they will not be able to be sold.

Medical Devices Requiring Post-Market In-Country Testing

The proposed list of devices that would need to be tested within Indonesia is below.

Types of Devices Test
1.       Ultrasound

2.       Continuous Ventilator

3.       Infusion Pump

4.       Syringe Pump

·         Electrical Safety Test and Performance test

·         IEC 60601 Electrical Safety Test for medical devices

·         Test product performance for medical devices that use batteries

5.       Condom ·         Test appearance

·         Dimensions

·         Density

·         Explosiveness

·         Leakage

6.       Disposable syringes

7.       IV cannula

8.       IV catheter

9.       Wing needle

10.   Fistula needle

11.   Infusion set with needle

·         Sterility test

·         Test the sharpness of the syringe

12.   Sterile gauze ·         Sterility test

·         Fluorescence test

13.   HIV RDT test

14.   RDT Syphilis test

15.   RDT Hepatitis test

16.   Dengue RDT test

·         Fluorescence Test

·         Sensitivity Test, Specificity Test and Post Market Test (Physical and Functional Test)

17.   Implanted devices

(Risk Class C and D)

·         Biocompatibility test (genotoxicity, cytotoxicity, sensitization)

·         ISO 10993 Biological Evaluation of Medical Devices

18.   Sterile devices ·         FI Sterilization Test VI
19.   Medical Device Software ·         IEC 62304 Medical Device Software – software life cycle processes

Laboratories Accredited for Post-Market Testing of Medical Device Products in Indonesia

A list of the accredited laboratories in Indonesia that can perform post-market testing was provided by the Ministry of Health.

Laboratory Products Test Parameters Test Method
1.    Airlangga Non-electromedical sterile Sterility Farmakope Indonesia VI
Tahun 2020
2.    Balai Besar Teksti (BBT) Medical Mask Bacteria Filtration Efficiency (BFE)

Differential Pressure

Microbial Cleanliness (Bioburden)

SNI EN 14683:2019+AC:2019 SNI 8489:2018
3.    BBLK Jakarta Non-Electromedical Sterile Sterility Farmakope Indonesia VI Tahun 2020
Medical Mask Bacteria Filtration Efficiency (BFE)

Differential Pressure

Microbial Cleanliness (Bioburden)

SNI EN 14683:2019+AC:2019 SNI 8489:2018
In Vitro Diagnostic Medical Devices Sensitivity and Specificity Depending on the product
Post-market Functional/Conformity Tests (RDT HIV, Syphilis, Dengue NS-1, Malaria, Hepatitis B, Covid-19) Post-market Testing Standards for Rapid Diagnostic Test (Rdt) Products, Indonesian Ministry of Health, 2022
4.    BBLK Surabaya In Vitro Diagnostic Medical Devices Sensitivity and Specificity Depending on the product
Post-market Functional/Conformity Tests (RDT HIV, Syphilis, Dengue NS-1, Malaria, Hepatitis B, Covid-19) Post-market Testing Standards for Rapid Diagnostic Test (Rdt) Products, Indonesian Ministry of Health, 2022
5.    BPFK Jakarta Electromedical Devices Electrical Safety Test SNI IEC 60601-1:2014+ Performance Test
6.    Genetech Non-Electromedical Sterile Sterility Farmakope Indonesia VI Tahun 2020
Medical Mask Bacteria Filtration Efficiency (BFE)

Differential Pressure

Microbial Cleanliness (Bioburden)

SNI EN 14683:2019+AC:2019 SNI 8489:2018
Syringe Needle Sharpness Test (needle friction, Needle fixing) ISO 7864:2016 4.11 Annex D
7.    Intertek Medical Mask Bacteria Filtration Efficiency (BFE)

Differential Pressure

Microbial Cleanliness (Bioburden)

SNI EN 14683:2019+AC:2019 SNI 8489:2018
8.    Klinik FKUI In Vitro Diagnostic Medical Devices Sensitivity and Specificity depending on the product
Post-market Functional/Conformity Tests (RDT HIV, Syphilis, Dengue NS-1, Malaria, Hepatitis B, Covid-19) Post-market Testing Standards for Rapid Diagnostic Test (Rdt) Products, Indonesian Ministry of Health, 2022
9.    Lab Mikobiologi In Vitro Diagnostic Medical Devices Sensitivity and Specificity depending on the product
Post-market Functional/Conformity Tests (RDT HIV, Syphilis, Dengue NS-1, Malaria, Hepatitis B, Covid-19) Post-market Testing Standards for Rapid Diagnostic Test (Rdt) Products, Indonesian Ministry of Health, 2022
10.  Lab UNPAD In Vitro Diagnostic Medical Devices Sensitivity and Specificity depending on the product
Post-market Functional/Conformity Tests (RDT HIV, Syphilis, Dengue NS-1, Malaria, Hepatitis B, Covid-19) Post-market Testing Standards for Rapid Diagnostic Test (Rdt) Products, Indonesian Ministry of Health, 2022
11.  Saraswanti Indo Non-Electromedical Sterile Sterility Farmakope Indonesia VI Tahun 2020
Medical Mask Bacteria Filtration Efficiency (BFE)

Differential Pressure

Microbial Cleanliness (Bioburden)

SNI EN 14683:2019+AC:2019 SNI 8489:2018
Syringe Needle Sharpness Test (needle friction, Needle fixing) ISO 7864:2016 4.11 Annex D
12.  Sucofindo Non-Electromedical Sterile Sterility Farmakope Indonesia VI Tahun 2020
13.  ULP FF Universitas Non-Electromedical Sterile Sterility Farmakope Indonesia VI Tahun 2020

Get Help with In-Country Testing Requirements with Asia Actual

For now, this requirement will be advisory and not enforced. However, Asia Actual expects that enforcement will begin in earnest at a later date. Our experts in Jakarta will monitor the situation and are happy to discuss the issue with clients.

Find out more about in-country testing requirements from the Indonesia Ministry of Health through Asia Actual. Our expert team in Jakarta is monitoring the situation closely and is in contact with officials regularly for clarification on new regulations, processes and costs for license holders. Contact us today for more information.

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