Indonesian Health Ministry Enforces Stricter Supervision of Good Distribution Practices for Medical Devices

To strengthen the supervision of medical devices distributed in Indonesia and to ensure that medical devices that have received a Marketing Authorization (Izin Edar) meet the safety, efficacy, and quality requirements, the Ministry of Health (“MOH”) has committed to stricter enforcement of Good Distribution Practices for Medical Devices (Cara Distribusi Alat Kesehatan yang Baik or “CDAKB”).

CDAKB Certificate Requirement

This commitment was underlined with the issuance of Circular Letter No. FR.03.01/E/884/2024 dated May 11, 2024, by the Director General of Pharmaceuticals and Medical Devices (“Circular Letter 03”). Circular Letter 03 requires medical device distributors to obtain a CDAKB certificate as a prerequisite to apply for a Marketing Authorization for medical devices, effective as of July 1, 2024.

While a CDAKB certificate has always been required for medical device distributors, it was not expressly regulated that the distributors were required to obtain a CDAKB certificate before applying for a Marketing Authorization. With the issuance of Circular Letter 03, it is now clear that the MOH will not issue Marketing Authorizations to medical device distributors without a CDAKB certificate.

To further ensure the implementation of CDAKB, the MOH issued Circular Letter No. HK.02.02/E/1753/2024 dated September 9, 2024 (“Circular Letter 02”). Circular Letter 02 stipulates that a CDAKB certificate is a requirement for medical device distributors to be able to display their medical devices in the Electronic Catalog managed by the Government Goods/Services Procurement Policy Agency (Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah or “LKPP”) (the “E-Catalog”). This requirement will be effective as of January 1, 2025.

Conclusion

Although Circular Letter 03 may not be effective in enforcing the CDAKB certificate requirement for medical device distributors that have already obtained Marketing Authorizations, Circular Letter 02 will effectively bar existing distributors that have obtained Marketing Authorizations but do not have a CDAKB certificate from distributing their medical devices through the LKPP’s E-Catalog system. Such distributors will be required to obtain a CDAKB certificate prior to offering their products in the E-Catalog.

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Liability for Digital Health Products and Services in Indonesia

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