After obtaining Class A medical device registration with Indonesia’s Ministry of Health (MOH), manufacturers and distributors must adhere to a range of regulatory requirements and obligations to ensure ongoing compliance with Indonesian medical device laws. These regulations help ensure that medical devices are safe, effective, and remain compliant throughout their lifecycle in the market. Below are the key regulations and requirements to follow post-registration:

1. Post-Market Surveillance (PMS)

• Regulation: Post-market surveillance is critical to ensure the ongoing safety and effectiveness of the device. This requirement is governed by Regulation No. 62/2017 (Concerning the Distribution of Medical Devices).

• Requirements:

  • Monitor device performance after it enters the market, including collecting data on adverse events or product failures.
  • Report adverse events: If there are any serious incidents or adverse events (such as device malfunctions, injuries, or deaths), you must report these to the Indonesian National Agency of Drug and Food Control (BPOM) or Ministry of Health.
  • Periodic review: Conduct regular reviews of product performance and user feedback to assess potential risks.

• Action: Set up a system to collect, review, and report adverse events, and track the device’s ongoing safety and performance in the market.

2. Labeling and Instructions for Use (IFU)

• Regulation: The labeling and packaging of medical devices are governed by Regulation No. 62/2017 and SNI (Indonesian National Standards) for medical devices.

• Requirements:

  • Ensure that all labels and instructions for use (IFUs) are in Bahasa Indonesia and compliant with Indonesian requirements.
  • Labels must include the device name, manufacturer or distributor details, device function, storage conditions, expiration date, and any necessary warnings or precautions.
  • Any advertisements or promotional materials must also comply with these standards and may require approval from the Ministry of Health.

• Action: Regularly check that your device labeling and IFUs remain compliant with current regulatory standards and language requirements.

3. Quality Management System (QMS) Maintenance

• Regulation: ISO 13485:2016 is the key standard for quality management systems for medical devices, and its implementation is closely monitored by regulatory authorities in Indonesia.

• Requirements:

  • Ensure that your QMS is continuously maintained and adheres to international and Indonesian standards, particularly ISO 13485.
  • Periodically undergo audits and reviews to verify the effectiveness of the QMS.
  • Corrective and Preventive Actions (CAPA) should be implemented for any issues identified during audits, inspections, or complaints.

• Action: Maintain ongoing compliance with ISO 13485 and be prepared for periodic inspections by the Indonesian authorities (e.g., BPOM, MOH).

4. Device Advertising and Promotion

• Regulation: Advertising and promotional activities are regulated by the Ministry of Health and must comply with Regulation No. 62/2017.

• Requirements:

  • Any advertisements or claims about your medical device must be truthful and supported by adequate scientific evidence.
  • Promotional materials, including advertisements and brochures, must not make misleading claims about the device’s capabilities.
  • Any marketing activities must be reviewed and approved by the MOH to ensure that they are not in violation of medical device advertising laws.

• Action: Review all advertising materials for accuracy and compliance with Indonesian regulations before publishing or distributing them.

5. Importation and Distribution Compliance

• Regulation: BPOM and MOH regulations govern the importation, distribution, and commercialization of medical devices in Indonesia.

• Requirements:

  • Ensure that all importation processes for the device comply with Indonesian customs and import laws, including proper customs clearance.
  • Devices should only be distributed by registered distributors in Indonesia. You must ensure your local distributor or representative complies with all distribution laws.
  • The Izin Edar (distribution license) issued by the MOH is valid for five years, and it must be renewed before it expires.

• Action: Work closely with your local distributor to ensure that all importation, distribution, and sales practices are compliant with Indonesian laws. Begin the renewal process for your Izin Edar before it expires.

6. Record Keeping and Documentation

• Regulation: Regulation No. 62/2017 and related laws require medical device manufacturers and distributors to maintain proper documentation for the life of the product.

• Requirements:

  • Maintain detailed records of your device’s design history, manufacturing process, risk management, clinical evaluations, and post-market performance.
  • Be prepared to provide this documentation to BPOM or MOH during inspections or audits.
  • Keep track of any complaints, adverse events, or recalls related to the device.

• Action: Set up a robust document control system to track all relevant documents, including technical files, clinical studies, risk assessments, and post-market surveillance reports.

7. Device Recalls and Field Safety Corrective Actions (FSCA)

• Regulation: The MOH requires that any necessary recalls or corrective actions be conducted in accordance with Regulation No. 62/2017.

• Requirements:

  • If a device is found to be defective or if it poses a safety risk, it must be recalled from the market. The manufacturer must notify both MOH and BPOM of the recall and take corrective action.
  • You must establish a process for field safety corrective actions (FSCA) to address issues in the field, which may include device replacement, upgrades, or warnings.

• Action: Develop a recall procedure and a corrective action plan that can be quickly activated in case of device failure or safety concerns.

8. Periodic Renewal of Registration (Izin Edar)

• Regulation: The Izin Edar is valid for five years, after which it must be renewed as per the regulatory requirements outlined in Regulation No. 62/2017.

• Requirements:

  • Submit a renewal application at least six months before the expiration of your Izin Edar.
  • Provide updated technical documentation, safety reports, and other required materials during the renewal process.

• Action: Start the renewal process in advance to ensure no interruption in the distribution of your device. Make sure the device continues to meet regulatory requirements before submitting the renewal application.

9. Inspections and Audits

• Regulation: The MOH and BPOM can conduct periodic inspections or audits to ensure that medical devices comply with safety, quality, and regulatory standards.

• Requirements:

  • Be prepared for inspections at the manufacturing site, the warehouse, and other relevant locations.
  • You must allow inspectors to review your records, QMS, and post-market surveillance data.
  • Cooperate with authorities during audits and address any findings or corrective actions required.

• Action: Keep all records and documentation readily accessible and ensure your facilities are prepared for potential inspections.

10. Ongoing Compliance with Indonesian Standards (SNI)

• Regulation: Medical devices in Indonesia must comply with relevant SNI (Indonesian National Standards) that apply to safety, performance, labeling, and quality.

• Requirements:

  • Ensure that your device continues to meet the latest SNI standards for medical devices, which may include changes in labeling, testing methods, and quality controls.
  • You may need to update your product to meet new SNI requirements as they evolve over time.

• Action: Regularly review updates to SNI and make necessary adjustments to your devices or documentation to maintain compliance.

Summary of Post-Registration Requirements:

1. Post-market surveillance and reporting of adverse events.
2. Ensure labeling and IFUs are compliant with Indonesian regulations.
3. Maintain a valid QMS that complies with ISO 13485.
4. Adhere to advertising and promotional guidelines.
5. Comply with importation and distribution laws and renew the Izin Edar.
6. Maintain proper records and documentation for audits and inspections.
7. Conduct recalls and corrective actions if necessary.
8. Start the process for Izin Edar renewal before expiration.
9. Prepare for potential inspections and audits by the MOH or BPOM.
10. Stay compliant with SNI and regulatory updates.

By following these regulations and requirements, you will ensure ongoing compliance with Indonesian medical device laws, safeguard the safety and effectiveness of your device, and maintain access to the market.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn