The time cycle for applying for D-class medical device registration in Indonesia typically involves several phases, and the overall processing time can vary based on the complexity of the application and the completeness of the documentation. However, for D-class (low-risk) devices, the process is generally faster compared to higher-risk classes. Here is a breakdown of the expected timeline and the steps involved in the review process:

Time Cycle for D-Class Medical Device Registration in Indonesia MOH:

1. Preparation Phase:

   • Timeframe: 1 to 3 weeks
     This phase involves preparing the necessary documentation, including:
   • Product details (name, intended use, classification).
   • Technical file (safety, performance data, testing).
   • ISO certification (if applicable).
   • Labels and instructions for use (in Indonesian).

   This stage can vary depending on how quickly the manufacturer or distributor can gather the required documents. Foreign manufacturers need to engage a local representative or distributor to help with the application process.

2. Submission Phase:

   • Timeframe: 1 to 2 weeks
     After the documents are ready, the application is submitted through the e-Registration system. This is a relatively quick step, as it involves filling out forms online and uploading the necessary files.

3. BPOM Review and Evaluation:

   • Timeframe: 3 to 6 months
     The majority of the processing time occurs during this review phase. For D-class devices, the review process is typically quicker than for higher-risk devices, but the exact time can depend on several factors:
   • Completeness and accuracy of the submitted documents.
   • The complexity of the device itself.
   • BPOM’s current workload and the volume of applications.

   If BPOM requires additional documentation or clarification, the process could be delayed.

4. Issuance of Registration Certificate:

   • Timeframe: 1 to 2 weeks after review approval
     Once the BPOM review is complete, and if the device is approved, the registration certificate is issued. This certificate is the official confirmation that the device can be marketed in Indonesia.

5. Post-Approval Activities (if applicable):

   • Once registered, the device can be imported and distributed in Indonesia. The post-market surveillance and adverse event reporting must be carried out by the local distributor.

Review Process for D-Class Medical Device Registration:

During the review phase, BPOM will carry out several evaluations to ensure the device meets Indonesian medical device standards and regulations. The review process includes:

1. Document Completeness Check:

• BPOM will first ensure that all required documents are submitted. Missing or incomplete documents can delay the process.
• Documents to review:
  • Product name, description, and intended use.
  • Manufacturer details (including certificate of free sale or equivalent).
  • Performance data, safety reports, and relevant test results.
  • Labeling in Indonesian language, including instructions for use (IFU).

2. Technical and Safety Evaluation:

• BPOM will evaluate the technical aspects of the device to ensure it is safe and performs as intended. This includes:
  • Review of biocompatibility and performance testing results (if applicable).
  • Ensuring the device adheres to local and international quality and safety standards (such as ISO 13485 or similar certifications).
  • Confirmation that the device does not present significant risks to health based on its intended use and classification as D-class (low-risk).

3. Labeling Compliance Review:

• BPOM will check that the labels and instructions for use (IFU) are compliant with Indonesian regulations, including:
  • Indonesian language requirements.
  • Inclusion of safety warnings, contraindications, and usage instructions.
  • Regulatory marking, including registration number and any necessary certifications.

4. Conformity to Indonesian Regulatory Standards:

• BPOM will verify that the device complies with the Indonesian Medical Device Act and associated regulations, particularly for:
  • Quality management systems (e.g., ISO 13485 certification).
  • Post-market surveillance and reporting systems (especially if adverse events occur).
  • Compliance with local standards or international equivalence (e.g., CE mark or FDA approval, if applicable).

5. Additional Requirements (if applicable):

• Local Representative Requirements: If the manufacturer is foreign, BPOM will verify that the local distributor or representative is officially registered and has the legal authority to handle the registration and importation process.
• Risk Assessment: Even for low-risk D-class devices, BPOM may request a basic risk assessment to ensure the device does not pose any unforeseen safety concerns.

Additional Notes on the Review Process:

• Clarification Requests: If BPOM identifies gaps or issues in the documentation, they will issue a request for clarification. This could extend the timeline by a few weeks, depending on how quickly the applicant can provide the necessary information.

• International Certifications: If the device has already been certified in other major markets (e.g., FDA, CE mark, or Japan PMDA), BPOM may expedite the review process by leveraging existing data to ensure compliance with Indonesian standards. However, local testing may still be required, depending on the device's nature.

Typical Total Time Cycle:

• Total time from application submission to registration: 3 to 6 months (for D-class devices).

  The timeline can vary depending on the completeness of the application, the specific type of device, and the current workload of BPOM. It's important to ensure that all documentation is thorough and accurate to minimize delays.

Summary of Key Steps in the Process:

1. Preparation Phase (1 to 3 weeks): Gather all necessary documents (technical file, certificates, labeling).
2. Submission to BPOM (1 to 2 weeks): Submit the registration application through the e-Registration system.
3. BPOM Review and Evaluation (3 to 6 months):
   • Completeness check.
   • Technical and safety evaluation.
   • Labeling review.
   • Compliance with regulatory standards.
4. Issuance of Registration Certificate (1 to 2 weeks after approval).
5. Post-Market Surveillance: Ongoing reporting as required.

The process is generally straightforward for low-risk devices, but it’s important to ensure thorough preparation to avoid delays. Regularly checking the status of your application in BPOM's e-Registration system can help manage expectations during the review period.