Before applying for Class C medical device registration in Indonesia through the Ministry of Health (MOH) and BPOM, you should make several critical preparations to ensure that the process runs smoothly and that your device meets all necessary regulatory requirements. Below are the key preparatory steps:

1. Understand the Classification and Regulatory Requirements

• Determine the Exact Classification: Ensure that your device is correctly classified as Class C according to BPOM’s classification system. Class C medical devices are those that pose moderate to high risk to patients but are not as critical as Class D (which involves the highest risk).
• Review BPOM Guidelines: Familiarize yourself with the latest BPOM regulations and guidelines, such as Regulation No. 27 of 2017, which outlines the registration process for medical devices, including Class C devices.

2. Confirm the Manufacturer’s Legal Status

• Manufacturer Information: Ensure that your company is legally established and that the manufacturer’s details (including the manufacturing license, business registration, and address) are documented and up-to-date.
• Authorized Representative (if applicable): If you are a foreign manufacturer, identify an authorized representative or local distributor in Indonesia who will act on your behalf for regulatory purposes. They must be registered with BPOM as an official importer of medical devices.

3. Ensure Compliance with Manufacturing Standards

• Good Manufacturing Practices (GMP): Make sure your manufacturing facility complies with GMP for medical devices. BPOM requires proof of compliance with GMP as part of the registration process, and foreign manufacturers must provide GMP certificates from the regulatory authority in their home country (e.g., FDA or EMA certifications).
• ISO Certifications: If your device is subject to ISO certifications such as ISO 13485 (Quality Management for Medical Devices) or ISO 14971 (Risk Management), ensure that these certifications are current and available for submission.

4. Prepare Required Technical Documentation

Prepare the following key documents as part of your registration application:

• Device Description: A detailed description of the medical device, including its intended use, principle of operation, and classification.
• Device Labeling: Ensure that your device labeling complies with BPOM’s labeling requirements. Labels should include device name, manufacturer information, serial number, usage instructions, and any warnings or precautions.
  • Labels and instructions must be in Bahasa Indonesia.
• Risk Management Documentation: Prepare a Risk Management Plan (ISO 14971) that outlines how the device’s risks are identified, evaluated, and mitigated.
• Clinical Data (if applicable): For Class C devices, you may need to submit clinical trial data or performance data that supports the device’s safety and efficacy. Ensure the data is compiled in accordance with ISO 14155 (Clinical Trials for Medical Devices).
• Technical File: This should include:
  • Device specifications.
  • Design and manufacturing processes.
  • Materials used (especially for biocompatibility).
  • Test reports (e.g., sterilization validation, electrical safety).
• Compliance with Standards: Provide evidence that your device complies with international standards such as ISO 13485, ISO 14971, and ISO 10993 (for biocompatibility testing, if applicable).
• Foreign Regulatory Approvals: If the device has been approved or registered in other countries (e.g., the FDA, EMA, or TGA), include these approvals or certifications as part of your submission.

5. Prepare Documentation for Importation (If Applicable)

• Authorized Importer: If you are a foreign manufacturer, ensure that the importer or distributor in Indonesia is registered with BPOM and has the necessary approval to import medical devices.
• Import License: Your importer should have the relevant import license issued by BPOM. They must submit this license when applying for registration.
• Customs Documentation: Ensure that all necessary customs documentation for importing the medical device is in order. This includes import permits and customs declarations.

6. Prepare for Clinical Evaluation (if necessary)

• Clinical Evaluation Reports: If required, ensure that a clinical evaluation or clinical trial report is prepared to demonstrate the device's safety and efficacy in real-world settings. This might include clinical data, studies, or performance validation reports.
• Ensure that clinical trials or evaluations comply with ISO 14155 and local regulations. If the device has already been used in other markets with acceptable results, these studies might suffice, but always check with BPOM for specifics.

7. Prepare a Local Representative

• Authorized Representative: If you are not located in Indonesia, you will need to appoint a local authorized representative (or distributor) who will serve as the official point of contact for BPOM.
• The authorized representative will be responsible for submitting the registration application, handling regulatory inquiries, and ensuring post-market compliance.

8. Prepare for Post-Market Surveillance (PMS)

• Post-Market Surveillance Plan: BPOM requires that companies have a Post-Market Surveillance (PMS) plan in place. This includes monitoring the device’s performance after it reaches the market to ensure it remains safe and effective.
• Adverse Event Reporting: Ensure that your company has a system for reporting any adverse events or device malfunctions to BPOM in accordance with local regulations. Prepare the necessary documentation for incident reporting if the device causes harm or malfunction.

9. Familiarize with BPOM’s Submission Platform

• BPOM uses an online platform called e-Registration for the submission of medical device applications. Make sure that your company profile is set up on the system and that you are familiar with the submission process. This will involve uploading various documents, paying registration fees, and tracking the status of your application.
• Ensure that the online system is regularly checked for any updates or requests for additional information from BPOM.

10. Plan for Registration Fees

• Registration Fees: Be prepared for registration fees that may be required when submitting your application to BPOM. Fees typically depend on the classification of the device and can vary. Ensure that the correct fee is paid at the time of submission.

11. Prepare for Possible BPOM Inspections

• BPOM may conduct inspections of your manufacturing facility, especially if you are a foreign manufacturer, to verify compliance with GMP and other regulatory standards. Ensure that your facility is ready for any potential audits or inspections.
• Make sure that your quality management system (QMS) and other records are up-to-date and available for review.

12. Understand the Timeline

• The process of medical device registration in Indonesia can take several months. Ensure that your company has adequate resources to handle the regulatory process, including time for document preparation, review cycles, and responses to any inquiries from BPOM.
• Be prepared for a long lead time and potential delays due to additional information requests or clarifications needed by BPOM.

Summary Checklist of Preparations:

1. Ensure correct classification of your device (Class C).
2. Review BPOM regulations and guidelines (Regulation No. 27 of 2017).
3. Verify GMP compliance and ISO certifications (if applicable).
4. Prepare technical documentation (e.g., device description, labeling, risk management plans, clinical data).
5. Ensure importation and distribution arrangements are in place, including having an authorized representative.
6. Prepare for clinical evaluations and clinical trials (if required).
7. Create a post-market surveillance plan and establish an adverse event reporting system.
8. Register on BPOM’s e-Registration platform and familiarize yourself with the submission process.
9. Plan for registration fees and ensure they are paid at the time of submission.
10. Prepare for BPOM inspections of the manufacturing facility.
11. Understand the timeline and plan resources accordingly.

By preparing all of these elements before applying for Class C medical device registration in Indonesia, you will be well-positioned to navigate the regulatory process successfully. If you need help with any specific part of the process or documentation, feel free to ask!

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