Indonesia has strong economic growth, an expanding middle class, and an urbanizing population. Western diseases are becoming more prevalent, providing further opportunities to Western medical device manufacturers. However, the growing healthcare market has led to increased government oversight. Companies wishing to conduct business in Indonesia must understand the medical device approval process and regulatory compliance necessary for access to the expanding market.
Pacific Bridge Medical’s regulatory consultants can help you register your medical device and get your product through Indonesian regulatory complexities to ensure rapid compliance with all regulations.
To continue reading about Indonesia’s medical device registration regulations and approval process, click on the following questions.
Which regulatory bodies in the Indonesian government are responsible for medical device registration in Indonesia?
The primary government agency in charge of regulations for medical devices and pharmaceuticals is the National Agency of Drug and Food Control (NA-DFC). This agency is also in charge of pre-market evaluation, standardization, legislation and GMP certification.
In Indonesia, are medical devices required to be registered before they can be sold?
Yes, medical devices require registration before they can be sold in Indonesia.
What are the different regulatory classifications for medical devices?
Medical devices in Indonesia are classified into 3 risk classes:
- Class I: Low Risk
- Class II: Moderate Risk
- Class III: High Risk
What does the registration pathway look like for each regulatory classification?
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:
- 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.
- 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.
- Timeline – If the application is complete, the total process generally takes about 6-12 months.
What are the document requirements for registration in Indonesia?
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:
- An introduction on the medical device, unique features, its intended uses, indications for use, and an outline of the CSDT content
- Commercial marketing history
- Intended uses and indications in labeling
- List of regulatory approval or marketing clearance obtained
- Status of any pending request for market clearance
- Important information in regards to performance and safety
The CSDT generally must include:
- Relevant essential principals and methods used to demonstrate conformity
- Essential principles and evidence of conformity
- Device description (features, intended use, indications, instructions for use, contraindications, warnings, precautions, potential adverse affects, other relevant specifications, etc.)
- Pre-clinical studies
- Device labeling
- Risk analysis
- Manufacturer Information
Is local testing (type testing/sample testing) required for registration?
Local testing will most likely not be required for registration in Indonesia.
Are clinical studies required for registration?
Clinical studies may be required for registration, but in most cases foreign clinical data is accepted.
Is approval in the Country of Origin required for registration?
Approval in the Country of Origin will most likely not be required for registration in Indonesia.
Contact us today for a free consultation with our Indonesia medical device regulation experts regarding Indonesia medical device registration for your product.
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