On September 22, 2023, the Ministry of Health of Indonesia held a socialization event regarding the Circular Letter on Post-Market Testing of Medical Devices Number HK. 02.02/E.VI/948/2023. This event aimed to deepen understanding and facilitate dialogue related to policies that have a significant impact on the medical device industry in Indonesia.

Post-Market Testing Policy: Prioritizing Safety and Product Quality

On July 21, the Ministry of Health announced a policy requiring post-market testing for medical devices. This policy is necessary to ensure that medical devices available in the market meet established safety, quality, and efficacy requirements. Key points in the announcement include:

Responsibility of License Holders
License holders are expected to conduct post-market testing on products in circulation to ensure that these products continue to meet safety, quality, and efficacy requirements independently.

Periodic Testing
Post-market testing will be conducted periodically, at least once every two years, and must be performed in accredited testing laboratories. The results of the testing must be reported electronically to the Ministry of Health through the Directorate of Medical Device Supervision.

Significance of Test Result Reports
Reports on post-market testing results will serve as the basis for consideration in the selection process of products to be included in the electronic catalog (e-catalog).

Considerations and Challenges in Implementing Post-Market Testing

The Director of Medical Device Supervision explained that this testing is essentially a recommendation and not an absolute requirement. The implementation of testing by companies after products enter the market raises several considerations. Some view it as an effective method for ensuring product quality, while others are concerned about the additional burden on license holders. If testing must be conducted every two years, it will undoubtedly impact the additional operational costs for license holders.

One significant challenge is the post-market testing that must be conducted by license holders for large products such as CT Scans. Most distributors do not keep a large stock of these products, and even if available, after testing, the products are likely to become used goods.

Reward from the Ministry of Health

The Ministry of Health stated that while there is no absolute obligation to conduct this testing, as a reward, they will recognize and list products on the Directorate of Supervision portal and prioritize them in the e-catalog. However, there are still many questions from participants regarding the mechanisms for freezing and unfreezing products in the e-catalog that will be applied with the introduction of post-market testing.

Conclusion: Need for Thorough Consideration

The Ministry of Health will evaluate the announcement made on July 21, taking into account the questions and input from various parties. The final decision regarding the implementation of post-market testing will have a significant impact on the development of the medical device industry in Indonesia and thus needs careful consideration.

To find out what tests are required for your products, please contact us. By reaching out to us, you will receive professional guidance on post-market testing relevant to your products, as well as the best solutions to meet all necessary requirements. We are ready to help you maintain the quality and safety of your products in today’s competitive health market.