{SPECIAL ARTICLE} Indonesian medical device regulation overview

In this report, below items related to registration of medical device in Indonesia are explained.

Regulation to be applied for medical device in Indonesia. Classification of medical device and production certificates in Indonesia Common Submission Dossier Templates (CSTD) for each Medical Device Class The registration procedure, labelling and special requirements for some product.

 

Indonesia has been regulating Medical device since 1991 to ensure safety, quality, performance/efficacy, affordable and appropriateness of medical device and to avoid risk of medical device, to reduce cost of public health care and ultimately to ensure patient safety.

 

Distributor and manufacturer who already decided to enter Indonesian market has to follow all related regulations on medical device registration. The government agency in charge of regulations for medical devices and pharmaceuticals are the National Agency of Drug and Food Control (NA-DFC) or locally known as BPOM and Ministry of Health, division on Directorate General of Pharmaceuticals and Medical Devices. These agencies are also in charge of pre-market evaluation, standardization, legislation and GMP certification.

 

BPOM is an independent non departmental government institution who coordinated by Ministry of Health Republic of Indonesia (MOH RI) but have a responsibility towards President. BPOM will give recommendation to MOH RI while MOH RI will issue a license.

 

Only a company which has the distribution license (locally known as IPAK) issued by the MOH as well as marketing authorization, can import medical devices. It is important to note that there can be only one legal importer and distributor for one product in Indonesia. Additionally the filing to MOH RI can be done via an e-registration online system which makes the process simple and efficient. The Registration import medical device license has a validity of minimum 2 years and maximum 5 years.…