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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.

WRITTEN BY

For further information, please contact:

Winnie Yamashita Rolindrawan – SSEK,
winnierolindrawan@ssek.com

Winnie Yamashita Rolindrawan - SSEK. Winnie Yamashita Rolindrawan holds a Bachelor of Laws in economic law from the University of Indonesia and a Master of Science in communications management. She also earned an LL.M. and a Business Law Certificate from UC Berkeley.

Winnie Yamashita Rolindrawan received her Bachelor of Laws in economic law from the University of Indonesia in 2002. In 2007, she earned her Master of Science from the Faculty of Social and Political Sciences at the same university, majoring in communications management. In 2016, Winnie received her Master of Laws (LL.M.) from the University of California, Berkeley, School of Law, where she also earned a Business Law Certificate from the Berkeley Center for Law and Business.

Winnie joined SSEK in 2007 and has represented major domestic firms and multinational companies in a variety of transactions. She has worked on numerous projects involving M&A, financial services and fintech, data privacy, pharmaceuticals and healthcare, corporate and commercial matters, foreign investment, e-commerce, and real estate and property (particularly hotels).

Her projects in the fintech sector include acting as Indonesian counsel to Didi Chuxing in the acquisition of a substantial stake in Grab Inc., a transaction valued at over US$1 billion, and acting as lead Indonesian counsel to Mastercard as the lead investor in the series B funding round of Digiasia, an Indonesian fintech startup. Winnie advises clients on all aspects of fintech and payment systems (including e-money, remittances, payment gateways and switching), from obtaining the relevant licenses to cross-border fintech M&A transactions and navigating complex regulatory, legal and commercial challenges to ensure compliance with the relevant fintech and payment system regulations of Indonesia’s Financial Services Authority (OJK) and Central Bank (Bank Indonesia).

In the healthcare sector, Winnie has represented pharmaceutical companies, including manufacturers and distributors, in providing practical solutions for their day-to-day operations, corporate and commercial contracts, and specific regulatory issues.

Prior to joining SSEK, Winnie worked at another prominent corporate law firm in Jakarta, where she was involved in various capital market transactions including IPOs, bond issues and rights issues. She helped handle several debt restructuring projects involving the Indonesian Bank Restructuring Agency (IBRA), an independent government agency established in response to the Indonesian financial crisis.

Winnie was also an associate procurement expert for an Asian Development Bank-Indonesian Ministry of National Development Planning (Bappenas) project, where she developed and drafted model national procurement documents.

Winnie is a licensed attorney and a member of the Indonesian Advocates Association (Peradi). She participated in the 2014 Academy of American and International Law, sponsored by the Southwestern Institute for International and Comparative Law in Dallas, Texas.

Having spent her childhood in Hamburg, Germany, she speaks German in addition to English and her native Indonesian.

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