Medical Device Registration in Indonesia

The primary government agency in charge of regulations for medical devices and pharmaceuticals is the Ministry of Health (MoH). This agency is also in charge of pre-market evaluation, standardization, legislation and GMP certification.

Yes, medical devices require registration before they can be sold in Indonesia.

These classifications are based on the level of risk associated with the use of medical devices to patients, users, or other parties:

1. Class A: Low risk
2. Class B: Moderate risk
3. Class C: Moderate to high risk
4. Class D: High risk

To prepare for integrating with the ASEAN medical products regulatory system, Indonesia has introduced a new online medical device registration system and now requires the Common Submission Dossier Template (CSDT). Device distributors and manufacturers apply for distribution licenses, production licenses and product registration through the online portal — which is now integrated with the Indonesian customs database. The steps of the registration pathway are as follows:

1. Obtain Distributor’s License – Companies that want to sell their devices in Indonesia must have both a distributor’s license and a product license before their products can enter Indonesia or be sold. Government regulations require a local distributor — either a domestic distributor or a local office.
2. Apply for Medical Device Registration – After a device company has received the distributor’s license from the MOH, the company must then apply for product licenses.
3. Timeline – If the application is complete, the total process generally takes about 6-12 months.

Product registration applications for medical devices must be prepared in the format set out in the CSDT document. An executive summary including the following must be provided with the CSDT:

1. An introduction on the medical device, unique features, its intended uses, indications for use, and an outline of the CSDT content
2. Commercial marketing history
3. Intended uses and indications in labeling
4. List of regulatory approval or marketing clearance obtained
5. Status of any pending request for market clearance
6. Important information in regards to performance and safety

The CSDT generally must include:

1. Relevant essential principals and methods used to demonstrate conformity
2. Essential principles and evidence of conformity
3. Device description (features, intended use, indications, instructions for use, contraindications, warnings, precautions, potential adverse affects, other relevant specifications, etc.)
4. Pre-clinical studies
5. Device labeling
6. Risk analysis
7. Manufacturer Information

Local testing will most likely not be required for registration in Indonesia.

Clinical studies are required for Class C and D medical devices.

Approval in the Country of Origin will most likely not be required for registration in Indonesia.