In September 2023, Indonesia’s Ministry of Health (MoH) published Circular Letter Number HK.02.02/E/1721/2023 concerning Post-Market Testing of Medical Devices, recommending independent post-market testing to be done by distributor license owners on circulated products, ensuring that products continue to meet safety and quality requirements.
The self-conducted post-market testing should be carried out periodically, at least once every 2 years, conducted by an accredited test laboratory, and reported to the MoH’s Directorate of Medical Device Supervision through their website. 

Post-market testing of the medical devices can be done voluntarily by the distributor license owners. Products that have submitted independent post-market test results within qualifications will be rewarded and will receive a priority benefit, considered as top-selection products in the e-Katalog. Those who have passed the post-market Evaluation process will also be listed and published on the Directorate of Medical Device Supervision website.

Medical devices that are a priority for independent post-market testing are listed in the table below:

Medical Device Group	Product Type	Testing
Non-electromedical Sterile	All product types	Sterilization test based on FI VI
Electromedical	USG Continuous Ventilator Infusion Pump Syringe Pump	Electrical Safety Test and Product performance test
Non-electromedical Sterile	Condoms	Test appearance, dimensions, density, explosive power, Leakage
Non-electromedical Sterile (products with needles)	Disposable Syringe IV Cannula IV Catheter Wing Needle Fistula Needle IV Set with needle	Sterility test
		Syringe sharpness test
Non-electromedical Sterile	Sterile Gauze	Sterility test
		Fluorescence Test
IVD	RDT HIV RDT Syphilis RDT Hepatitis RDT Dengue	Sensitivity Test, Specificity Test and Post Market Test (Physical and Functional Test)

*Note: The samples taken are not leftover samples or samples that are in the production facility storage warehouse.

 

 

References:
Circular Letter Number HK.02.02/E/1721/2023 concerning Post Market Testing of Medical Devices

22^nd September 2023 Socialization of Medical Device Post-Market Testing Circular YouTube Live Recording

22^nd September 2023 Socialization Materials - Mechanism for Implementing Independent Post Market Tests for Business Actors