Cost and Timeline for D-Class Medical Device Registration in Indonesia MOH

The cost and timeline for registering a D-class medical device in Indonesia with the Ministry of Health (MOH) and the National Agency of Drug and Food Control (BPOM) can vary depending on several factors, including the specific device, the completeness of the application, and BPOM's current workload. However, there are general guidelines you can expect in terms of both cost and time.

1. Cost of D-Class Medical Device Registration

The cost for registering a D-class medical device in Indonesia typically includes the following:

A. Registration Fee

• Registration fees for medical devices in Indonesia are determined by BPOM and can vary based on the device type and classification. For a D-class device, which is considered a low-risk device, the registration fee tends to be relatively low compared to higher-risk classes.
• As of recent information, the fee for registering a D-class medical device is typically around IDR 5,000,000 to IDR 10,000,000 (approximately USD 300 to USD 650). The exact fee will depend on BPOM's specific fee structure at the time of your application.

B. Additional Costs

In addition to the registration fee, there may be other associated costs, including:

• Local Authorized Representative/Distributor Fees: If you hire a local representative to manage the registration process, they may charge a fee for their services. These fees vary depending on the company and the complexity of the device but typically range from USD 1,000 to USD 5,000.
• Translation Fees: If your documents need to be translated into Indonesian, you may incur additional costs for certified translation services.
• Other Administrative Costs: These could include fees for obtaining a Certificate of Free Sale (CFS), ISO certifications, and other regulatory compliance documents.

C. Payment Method

• The registration fee is generally paid through BPOM’s e-Registration portal. The fee structure is clearly outlined during the registration process, and payment is made via the online system.

2. Timeline for D-Class Medical Device Registration

The timeline for registering a D-class medical device with Indonesia MOH typically depends on several factors, such as the completeness of the application, BPOM’s current workload, and any additional information requested. However, the general timeframe is as follows:

A. Estimated Timeline

• Initial Submission and Document Review: The review of documents by BPOM can take anywhere from 1 to 3 months. BPOM may request additional information or clarification during this period, which could extend the processing time.
• Approval and Issuance of Registration Certificate: After successful review, the approval process and issuance of the Registration Certificate can take another 1 to 2 months.
• Overall, the total time to register a D-class medical device in Indonesia is typically around 2 to 6 months, depending on the factors mentioned above.

B. Factors that Affect Timeline

• Completeness of the Submission: If the documents submitted are complete and accurate, the process will likely move faster. Incomplete or unclear applications will delay the review.
• BPOM’s Workload: BPOM processes many medical device registrations, so during peak times, the review process might take longer.
• Request for Additional Information: If BPOM requires further documentation or clarification, this can extend the timeline.

3. Tips to Expedite the Process

• Engage a Local Authorized Representative Early: Working with an experienced local representative or distributor can help ensure that your application is complete and complies with all Indonesian regulations. They can also help navigate any requests for additional information quickly.
• Prepare Complete and Accurate Documentation: Make sure all required documents (e.g., CFS, labeling, instructions for use, quality certifications) are correctly prepared and translated into Indonesian if necessary.
• Monitor BPOM’s e-Registration System: Regularly check the e-Registration portal for any updates or requests from BPOM to ensure you can address them promptly.

Summary:

• Cost:
  • Registration Fee: Around IDR 5,000,000 to IDR 10,000,000 (USD 300 to USD 650)
  • Other Costs: Local representative/distributor fees, translation fees, other administrative costs.
• Timeline: Typically takes around 2 to 6 months, depending on the completeness of the submission and BPOM’s workload.

By preparing thoroughly and engaging a reliable local representative, you can help ensure that your registration process proceeds as smoothly and efficiently as possible.