In an effort to improve the quality of medical devices distributed in Indonesia, the Indonesian MOH has put in place stricter guidelines. According to the new Circular Letter 03, starting on July 1, 2024, it will now be required that Indonesian medical device distributors obtain a CDAKB certificate (Cara Distribusi Alat Kesehatan Yang Baik) before they can apply for marketing authorization. In addition, the Indonesian MOH issued Circular Letter 02 on September 9 stating that it will also be a necessity that all Indonesian medical device distributors will need a CDAKB certificate to display their products in Indonesia’s Electronic Catalogue (e-catalogue) – which is run by the Procurement Policy of the government and is the major buyer of devices in the country. This new policy, Circular 02 will begin on January 1, 2025.
For Indonesian medical device distributors who had already obtained market authorizations before Circular 03 was put in place and may not have a CDAKB certificate, Circular 02 will bar such distributors from the Indonesian e-catalogue. Long story short, to be in compliance in Indonesia for the sales and marketing of medical devices there, Indonesian distributors will need to closely follow these two new Circulars.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.