On 21 April 2025, the Directorate General of Pharmaceuticals and Medical Devices of the Ministry of Health of Indonesia issued a new Circular Letter updating the approved list of laboratories for testing medical devices and health supplies under the SNI ISO/IEC 17025:2017 standard.
The updated regulation is detailed in Circular Letter Number HK.02.02/E/673/2025.
Key Highlights
The updated list, attached in Appendix 2 (referred to as “Lampiran 2” in the attached Circular Letter), includes the following changes:
- Addition of testing laboratories newly accredited under SNI ISO/IEC 17025:2017,
- Expansion of testing scopes in several registered laboratories, and
- Revisions to the nomenclature of certain laboratory names.
This list may be continuously updated in line with ongoing efforts to strengthen the testing laboratory network. It is intended to support relevant stakeholders, particularly license holders, in ensuring the safety and quality of medical devices and household health supplies through both pre-market and post-market testing.
Implications to Clients
Clients intending to conduct product testing may refer to this updated list of testing laboratories.
Effective Date
Effective immediately
Attachment
- [Circular Letter Number HK.02.02/E/673/2025 (Bahasa Indonesia)] – No English translation available
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