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


Non-electromedical Sterile

All product types

Sterilization test based on FI VI


Continuous Ventilator
Infusion Pump
Syringe Pump

Electrical Safety Test and Product performance test

Non-electromedical Sterile


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


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.



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

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

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