The cost and time required for Class I medical device registration with the Indonesia Ministry of Health (MOH) depend on several factors, including the specific device, the complexity of the application, and the efficiency of the process. However, I can provide an estimated range based on typical registration processes:

1. Cost for Class I Medical Device Registration in Indonesia

• Registration Fees: The fees for registering a Class I medical device with the Indonesian Ministry of Health (MOH) are relatively low compared to higher-risk devices (Class II or III). However, the exact cost may vary depending on the type of device and the service fees charged by local representatives or registration agents.
• Estimated Fees: The fees typically range from IDR 1,000,000 to IDR 10,000,000 (approximately USD 65 to USD 650), though this can vary.
  • Local Representation Costs: If you are using a local authorized representative (AR), their service fees for handling the registration process could add additional costs. These fees can range from IDR 5,000,000 to IDR 15,000,000 (approximately USD 325 to USD 1,000) depending on the complexity of the registration and the local AR’s pricing structure.
  • Additional Costs: There may also be extra costs for document translation, labeling, and administrative services, which could add to the overall cost of registration.

2. Time Required for Class I Medical Device Registration

• Registration Timeline: For Class I devices, the process is typically faster than for higher-risk devices, but the timeline can still vary depending on factors such as document completeness and BPOM’s workload.
• Estimated Timeline: The registration process for Class I devices generally takes between 1 to 3 months (approximately 4 to 12 weeks).
  • Initial Review and Approval: After submitting the application through the e-RD system, BPOM usually takes 2 to 4 weeks to conduct the initial review and evaluate the submitted documents.
  • Possible Delays: Delays can occur if additional information is requested by BPOM or if there are issues with documentation (e.g., missing documents, incorrect translations). If everything is in order, the process tends to be quicker.

Summary

• Cost: Approximately USD 65 to USD 650 for registration fees, with additional costs for local representation and other services, potentially bringing the total to USD 1,000 or more.
• Time: Approximately 1 to 3 months, depending on document completeness, BPOM’s review process, and potential delays.

By ensuring that your application is complete and accurate, you can minimize delays and expedite the registration process. Working with an experienced local authorized representative can also help streamline the process.

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