Before applying for D-class medical device registration with the Ministry of Health (MOH) in Indonesia, there are several essential preparations to ensure that your application is complete, accurate, and meets the regulatory requirements. Here’s a comprehensive guide to the steps you should take before starting the registration process:

1. Understand the Regulatory Framework

• Review the Relevant Regulations: Familiarize yourself with the key regulations governing medical device registration in Indonesia:
  • Regulation No. 62/2017 on Medical Devices and Household Health Supplies.
  • BPOM Regulation No. 26/2018 on Medical Device Registration.
  • BPOM Regulation No. 28/2021 for simplified registration processes for low-risk devices like D-class medical devices.
• Device Classification: Ensure your device qualifies as a D-class (low-risk) medical device. D-class devices have minimal risk and generally require simpler documentation and fewer testing requirements.

2. Appoint a Local Authorized Representative (for Foreign Manufacturers)

• Legal Requirement: If you are a foreign manufacturer, appoint a local authorized representative or distributor in Indonesia who is registered with BPOM.
• Responsibilities: Your local representative will manage the entire registration process, liaise with BPOM on your behalf, and be responsible for post-market surveillance and compliance.
• Agreement: Draft a clear agreement between your company and the local representative or distributor, outlining responsibilities for registration, marketing, and regulatory compliance.

3. Prepare the Necessary Documentation

Ensure you gather all the documentation required for D-class medical device registration. These documents include technical, regulatory, and administrative information about your product. Key documents to prepare include:

• Product Information and Specifications:
  • Product name, model number, and intended use.
  • Functionality and technical specifications of the device.
  • Design and material composition, including information about any components or materials in contact with the body (if applicable).
• Certificate of Free Sale (CFS):
  • If the device is manufactured outside of Indonesia, obtain a CFS from the regulatory authority in the country of origin (e.g., FDA (USA), CE marking (Europe), etc.). This certificate confirms that the device is legally sold in the country of manufacture.
  • The CFS should be recent (usually within the past year) and correspond to the specific model and brand of the device.
• Quality Management System (QMS) Documentation:
  • If your company has a certified QMS (e.g., ISO 13485:2016), include the relevant certification documents. Though not always mandatory for D-class devices, this can demonstrate that your manufacturing process meets international quality standards.
• Product Testing and Performance Data:
  • Provide test reports that demonstrate the device's safety, performance, and compliance with relevant standards (e.g., IEC 60601, ISO 10993, etc.). This is particularly relevant if the device involves electrical components, sterilization, or biocompatibility concerns.
• Labeling and Instructions for Use (IFU):
  • Product labeling must meet Indonesian requirements, including the product name, batch/serial number, expiration date (if applicable), and manufacturer information.
  • Instructions for Use (IFU) must be in Indonesian or accompanied by an official translation. The IFU should include detailed instructions for device use, storage, safety warnings, and maintenance.
• Manufacturing Information:
  • Provide details about the manufacturer's facilities and the production process. If the device is manufactured under a Quality Management System (QMS), include the relevant certifications (e.g., ISO 13485).
  • Manufacturing site license: If applicable, provide documentation that verifies the manufacturing site adheres to local Good Manufacturing Practices (GMP).
• Local Distributor Agreement (for foreign manufacturers):
  • A signed agreement with the local distributor or representative in Indonesia, confirming their responsibility for registration, marketing, and regulatory compliance.

4. Ensure Compliance with Indonesian Labeling Requirements

• The Indonesian National Agency of Drug and Food Control (BPOM) requires that all medical device labels are in Indonesian or have an official translation.
• Required Information on Labels:
  • Product name, model, and intended use.
  • Manufacturer or distributor information.
  • Batch or serial number and expiry date (if applicable).
  • Storage and handling instructions.
  • Safety warnings and precautions.

5. Verify Product Classification and Risk Level

• D-class medical devices are categorized as low-risk devices, but you should confirm that your device fits this classification based on its intended use, design, and risk profile.
• Classification Criteria: D-class devices typically have minimal potential to harm the user or patient. Ensure that the product does not involve high-risk factors such as direct patient contact (e.g., implants or devices that support life functions).

6. Identify Relevant International Standards

• Ensure that your device complies with applicable international standards. Key standards for D-class devices may include:
  • ISO 13485: Quality management for medical devices.
  • ISO 14971: Risk management for medical devices.
  • IEC 60601 (if applicable): Electrical safety for medical devices.
  • ISO 10993: Biocompatibility testing (if the device has contact with the body).
• These standards will help demonstrate that your device is safe, effective, and meets regulatory expectations.

7. Prepare for Potential Audits or Inspections

• BPOM may conduct audits or inspections of the manufacturing facility, especially if the device is imported. Be prepared for potential on-site inspections.
• Make sure that the manufacturing facility is compliant with relevant Good Manufacturing Practices (GMP) or other applicable quality standards.

8. Develop a Post-Market Surveillance Plan

• Prepare a plan for post-market surveillance (PMS) to monitor the safety and performance of the device once it’s on the market. This includes:
  • Adverse event reporting: Establish a system for reporting and tracking any device malfunctions, adverse events, or safety concerns.
  • Device recall procedures, if necessary, in case of safety issues.
• Having a PMS plan in place is critical for regulatory compliance and maintaining product safety over time.

9. Plan for Importation and Distribution in Indonesia

• Importation Process: Ensure you have all the necessary documentation and arrangements in place to import the device into Indonesia. This includes working with a local distributor and making sure they are familiar with Indonesian customs and import regulations.
• Customs Declarations: Make sure that customs documentation accurately reflects the registered device details when importing into Indonesia.

Summary of Preparations:

1. Familiarize yourself with Indonesian regulations (BPOM, Ministry of Health).
2. Appoint a local authorized representative or distributor.
3. Prepare all required documentation, including:
   • Product specifications, testing data, and performance reports.
   • Certificate of Free Sale (CFS).
   • Quality management system documentation (ISO 13485, if applicable).
   • Product labeling and Instructions for Use (IFU) in Indonesian.
4. Verify the device classification (ensure it qualifies as D-class).
5. Ensure compliance with international standards (ISO, IEC, etc.).
6. Prepare for audits or inspections of the manufacturing facility.
7. Develop a post-market surveillance plan.
8. Plan for the importation and distribution of the device in Indonesia.

By making these preparations, you can ensure a smoother and more efficient application process for registering your D-class medical device with the Indonesian Ministry of Health (MOH) and BPOM.

Contact Us：

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