Cost and Timeline for B-Class Medical Device Registration in Indonesia (MOH/BPOM)

The cost and timeline for registering a B-class medical device in Indonesia with the Ministry of Health (MOH) and BPOM can vary depending on several factors, such as the type of device, the complexity of the registration process, and the need for additional testing or inspections. Below is a general overview of the costs and timelines involved:

1. Cost of Registration

The registration fee for a B-class medical device in Indonesia typically consists of the following components:

• Registration Fee: BPOM charges a fee for processing the registration of medical devices. The fee depends on the class of the device, with B-class devices generally costing less than C- and D-class devices.

  • The approximate cost for B-class medical device registration is typically IDR 1,000,000 to IDR 3,000,000 (approximately USD 65 to USD 195).
  • The exact fee will be confirmed during the application process in the BPOM e-Registration portal, as fees may change or vary depending on specific device categories.

• Other Costs:

  • Local Representative Fees: If you appoint a local authorized representative (required for foreign manufacturers), there may be additional costs for their services.
  • Translation Fees: Documents must be translated into Bahasa Indonesia, which may incur additional costs for professional translation services.
  • Testing Fees: If BPOM requires performance testing, clinical trials, or local inspections, these may involve additional costs for testing at accredited labs.
  • Certification Costs: If the device requires certificates like ISO 13485 (Quality Management System) or a Free Sale Certificate, these certifications may also come with associated costs.

2. Timeline for Registration

The timeline for the registration of a B-class medical device in Indonesia can range from several weeks to a few months, depending on the complexity of the device and the efficiency of the submission. Here’s an approximate breakdown of the timeline:

a. Submission and Documentation Review:

• Once you submit the application through the BPOM e-registration portal, the initial review of documents typically takes 2 to 4 weeks.
• BPOM will review the product’s safety, labeling, and performance information. If the submission is complete, BPOM will begin the evaluation process.

b. Additional Testing or Inspection (if required):

• Local Testing: If BPOM requests local testing or inspection, this can add time to the process. Testing typically takes 4 to 8 weeks depending on the device type and testing facility.
• Manufacturing Facility Inspection: If an inspection is required for the manufacturing facility (especially for foreign manufacturers), this can add 2 to 4 weeks.

c. Final Approval and Issuance of Registration Certificate:

• After the BPOM review and testing phase (if applicable), final approval and issuance of the Surat Izin Edar (SIE), the registration certificate, usually takes 2 to 4 weeks.
• Total Timeline: The entire process for B-class medical device registration typically takes about 2 to 4 months from the submission of the application to receiving the registration certificate, assuming all documents are complete and no major issues arise.