After applying for Class II medical device registration with the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control) in Indonesia, manufacturers and authorized representatives must comply with various regulations and requirements during the application process and post-registration phase. Compliance with these rules is essential to avoid delays, ensure the smooth approval of the device, and maintain regulatory adherence in the market. Below are the key regulations and requirements that must be followed after submitting your application:

1. Regulatory Framework and Key Regulations

The regulatory framework for medical device registration in Indonesia is governed by several key regulations and guidelines. You must ensure that all activities comply with the following:

a. Regulation of the Minister of Health (PMK) No. 62/2017

This regulation outlines the requirements for medical devices in Indonesia, including:

• Registration Procedures for medical devices.
• Classification of medical devices (Class I, II, III, etc.) and the corresponding registration requirements.
• Requirements for clinical trials, technical documents, and post-market surveillance.

b. BPOM Regulation No. 27/2017

This regulation provides the specific requirements for registering medical devices with BPOM, including:

• Document Submission requirements.
• The technical documentation needed to support the registration.
• Evaluation Process by BPOM before approval.

c. BPOM’s Good Manufacturing Practice (GMP) Guidelines

Manufacturers must adhere to the GMP guidelines to ensure their devices are produced under controlled conditions and comply with regulatory standards for safety, quality, and consistency.

d. BPOM's Adverse Event Reporting Requirements

Once the device is on the market, manufacturers or their authorized representatives must follow the adverse event reporting requirements as outlined by BPOM. This includes reporting any device-related issues that could affect user safety.

2. Post-Application Obligations and Compliance

After applying for the Class II medical device registration, you must fulfill several obligations and comply with ongoing requirements:

a. Technical Document Submission (during evaluation)

• Verification of Document Completeness: BPOM will review the submitted documents for completeness and accuracy. Be prepared to provide additional or updated documents if requested by BPOM.
• Compliance with Technical Requirements: BPOM may request technical documents such as clinical data, testing reports, and risk management files. Ensure that your documents meet the standards outlined by ISO 13485, ISO 14971, and ISO 10993 (for biocompatibility).

b. Labeling and Instructions for Use (IFU) Compliance

• Bahasa Indonesia Labeling: Ensure that all product labeling, packaging, and Instructions for Use (IFU) are in Bahasa Indonesia and meet the local requirements set by BPOM.
  • The labels must include:
    • The device's intended use.
    • Manufacturer and distributor details.
    • Expiration dates (if applicable).
    • Storage and handling instructions.
    • Warnings and contraindications (if applicable).
• Approval of Promotional Materials:
  • Any promotional or advertising materials must also comply with BPOM’s regulations and may need to be submitted for approval before use. Ensure that marketing claims are accurate and supported by clinical data.

3. Compliance with Post-Market Surveillance (PMS) Requirements

Once your device is approved and registered, it is subject to Post-Market Surveillance (PMS). This ensures ongoing compliance with safety and performance standards throughout the device’s lifecycle in the market.

a. Adverse Event Reporting

• Reporting Adverse Events: You are required to monitor adverse events related to the device and report them to BPOM within the required timeframe (typically 15 days from discovery of the issue).
  • Serious adverse events (e.g., life-threatening issues or product defects) must be reported immediately.
  • For less severe incidents, you may have a longer period (usually 30 days) to report.
• Investigation and Corrective Actions:
  • If adverse events are reported, manufacturers must investigate and implement corrective actions if necessary. This could include device modifications, updates to the IFU, or even product recalls.

b. Monitoring Device Performance

• Ongoing Safety and Efficacy Monitoring: Manufacturers must monitor the performance and safety of their devices in the market. Collect feedback from healthcare professionals, distributors, and users about the device’s performance, reliability, and safety.

• Product Recalls:

  • If a defect or safety concern arises after the device is on the market, BPOM may request a product recall. Ensure that you have a recall management plan in place and follow BPOM’s procedures for removing affected devices from the market.

4. GMP (Good Manufacturing Practice) Compliance

For ongoing compliance with Good Manufacturing Practices (GMP):

• Facility Inspections: BPOM may conduct routine inspections of your manufacturing facility to verify adherence to GMP standards. Ensure that your manufacturing processes meet the required quality control and safety standards as outlined by BPOM.

• Import Compliance (for Imported Devices): If the device is being imported, ensure that the importer is registered with BPOM and follows all importation regulations, including the submission of customs documents and clearance procedures.

5. Renewal of Registration

Class II medical device registrations in Indonesia are typically valid for 5 years from the date of approval. To maintain the validity of your registration:

• Initiate Registration Renewal: Apply for renewal at least 6 months before the expiration date to avoid disruptions in your product's availability in the market.
• Submit Updated Documentation: BPOM may request updated documents, such as new clinical evaluation reports, certificates of compliance, or proof of ongoing GMP adherence.

6. Notifications of Changes and Modifications

If you make any changes to the device or its manufacturing process, these changes must be reported to BPOM:

• Device Modifications:
  • If you modify the design, intended use, or labeling of the device, BPOM must be notified, and in some cases, the device may need to undergo a new evaluation.
• Changes in Manufacturer or Distributor:
  • If there is a change in the manufacturer, authorized representative, or distributor, BPOM must be notified, and updated documentation may need to be submitted.

7. Conducting Clinical Trials (If Applicable)

If your device requires clinical trials for registration (or post-market surveillance):

• Ethics Committee Approval: Clinical trials conducted in Indonesia require approval from an Ethics Committee. Ensure that any studies meet the relevant ethical guidelines and that data is submitted to BPOM if necessary.
• Data Submission: Submit any clinical trial data to BPOM as part of your registration or post-market monitoring.

8. Export Documentation and Reporting

Once the device is registered in Indonesia, you may need to provide documentation for exporting the device to other markets:

• Certificate of Free Sale:
  • BPOM may issue a Certificate of Free Sale (CFS) for your device, which certifies that the product is legally sold in Indonesia. This document is often required when exporting the device to other countries.

9. Advertising and Marketing Compliance

• Advertising Claims:
  • Ensure that all advertising and marketing materials for the medical device are truthful and do not make false or misleading claims about the device's capabilities. BPOM regulates the promotion of medical devices and may require the submission of promotional materials for approval before they can be used in the market.
• Clinical Evidence for Claims:
  • Any claims made about the device in promotional materials (e.g., efficacy, safety) must be substantiated with clinical evidence and regulatory approval.

Summary of Key Post-Application Compliance Requirements

1. Document Verification: Ensure your application documents are complete and accurate. Be prepared to provide additional information if requested by BPOM.
2. Labeling and IFU: Ensure compliance with Bahasa Indonesia language requirements for product labeling and instructions.
3. Post-Market Surveillance: Implement monitoring, adverse event reporting, and product recall procedures as required.
4. GMP Compliance: Maintain compliance with GMP guidelines, especially during manufacturing and importation.
5. Registration Renewal: Apply for renewal before the registration expires (5 years) and submit any necessary updates.
6. Modification and Change Reporting: Notify BPOM of any changes to the device, manufacturing processes, or distributors.
7. Clinical Trials: If required, obtain approval for clinical trials and submit trial data to BPOM.
8. Advertising and Promotion: Ensure promotional materials comply with BPOM guidelines and are supported by clinical data.

By following these post-application regulations and requirements, you can ensure that your Class II medical device remains compliant with Indonesian laws and remains available for sale in the market. Would you like more information about any of these steps?

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