The costs and timelines for registering Class II medical devices with the Indonesian Ministry of Health (MOH) through BPOM can vary based on several factors, including the complexity of the device, whether it requires additional testing or inspections, and the efficiency of the registration process. Below are some general guidelines:

1. Registration Costs

The registration fees for Class II medical devices are subject to change, and it’s important to verify the latest information from BPOM or through your local authorized representative. However, typical costs include:

• Application Fee: BPOM charges a fee for the registration process, which may vary depending on the type of device and the complexity of the documentation. The cost typically ranges between IDR 5,000,000 to IDR 15,000,000 (approximately USD 300 to USD 1,000).
• Factory Inspection Fee: If a factory inspection is required (e.g., for locally manufactured devices or high-risk devices), there may be additional fees. The cost of a factory inspection can range from IDR 10,000,000 to IDR 20,000,000 (approximately USD 600 to USD 1,300).
• Translation Fees: All documentation, including labels, instructions for use, and technical files, must be translated into Bahasa Indonesia. Translation costs can vary but generally range from IDR 1,000,000 to IDR 3,000,000 (approximately USD 60 to USD 200).
• Consulting/Agent Fees: If you work with a local regulatory consultant or agent to manage the process, their service fees may range from IDR 10,000,000 to IDR 50,000,000 (approximately USD 600 to USD 3,200), depending on the scope of work.

2. Timelines

The timeline for registering a Class II medical device with BPOM typically varies from 3 to 6 months, depending on several factors:

• Initial Review: Once BPOM receives the application, the initial review of the documentation typically takes 1 to 2 months. This period involves checking the completeness of documents, evaluating product safety and effectiveness, and verifying that all regulatory requirements are met.

• Technical Evaluation: After the initial review, BPOM will conduct a technical evaluation, which usually takes 2 to 3 months. The timeline can be affected by the complexity of the device, whether additional testing or information is required, and BPOM’s current workload.

• Factory Inspection: If BPOM requires a factory inspection, this can add additional time to the process. Depending on the availability of inspection slots and the location of the manufacturer, this could delay the process by 2 to 4 weeks or longer.

• Registration Certificate Issuance: After BPOM completes the review and evaluation, the Registration Certificate (Surat Tanda Pendaftaran, STP) is typically issued within 1 to 2 weeks if all requirements are satisfied.

3. Renewal and Ongoing Costs

• Registration Validity: The registration certificate is valid for 5 years from the date of issuance.
• Renewal: After 5 years, a renewal application must be submitted, which involves additional fees and a new round of documentation review. This process can take 3 to 4 months.