Indonesia Tightens Enforcement of Medical Device Licensing

With the implementation of Regulation No. 60, 2017 on February 1st, 2018 the Indonesia government tightened enforcement of medical device licensing requirements.

Formerly, compliance for imported medical devices was confirmed during the customs clearance process by Customs and Excise Department officials. Now the Ministry of Health is authorized to extend confirmation through inspection at medical device distributors (AKA, Post-Border monitoring).

Any devices without proper licensing may result in re-exportation or destruction at the importers expense. Further, distributors in possession of improperly licensed devices may have their Distribution License suspended.  The move is expected to increase compliance with the medical device registration requirements.

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