In an effort to oversee the quality of Medical Devices and Household Health Supplies (PKRT) in accordance with Law No. 17 of 2023 on Health, the Indonesian Ministry of Health issued Circular Letter No. HK.02.02/E/2379/2023 on December 5. This circular presents a list of accredited testing laboratories for medical devices and PKRT that have received SNI ISO/IEC 17025:2017 accreditation. The availability of these laboratories aims to support the assurance of quality for medical devices and PKRT through both pre-market and post-market testing, including domestic products.

List of Accredited Laboratories

To ensure that medical devices and PKRT meet the established safety, quality, and efficacy requirements, it is crucial to rely on accredited testing laboratories. The list of accredited testing laboratories, provided in Appendix 2 of the circular, offers comprehensive information about laboratories that have achieved SNI ISO/IEC 17025:2017 accreditation. This accreditation covers the scope of testing for medical devices and/or PKRT.

Benefits of Laboratory Network

License holders, as key stakeholders, can utilize this list of laboratories to ensure that their products have undergone rigorous testing in accordance with applicable standards. Pre-market and post-market testing will help guarantee the safety and quality of products, including domestic offerings. This network of laboratories is an integral part of efforts to monitor and enhance the quality of health products.

Regular Updates

It is important to note that the list of laboratories, along with information related to products, types of testing, and testing methods, will be updated regularly. These updates will occur in line with the ongoing strengthening of the laboratory network for medical devices and PKRT. This ensures the information remains relevant and can accommodate the latest developments in the health sector.

Contact Us for More Information

For further inquiries, please refer to the source: SURAT EDARAN TENTANG DAFTAR JEJARING LABORATORIUM PENGUJIAN ALAT KESEHATAN DAN PERBEKALAN KESEHATAN RUMAH TANGGA TERAKREDITASI SNI ISO/IEC 17025:2017.