Before applying for Class I medical device registration with the Indonesia Ministry of Health (MOH) through BPOM, it is important to make thorough preparations to ensure that your application is complete, accurate, and compliant with Indonesian regulations. Proper preparation will help streamline the registration process and minimize delays.

Key Preparations Before Applying for Class I Medical Device Registration with Indonesia MOH

1. Appoint a Local Authorized Representative (AR)

• Requirement: Foreign manufacturers must have a local authorized representative (AR) in Indonesia who is responsible for managing the registration process and ensuring ongoing compliance.
• Steps:
  • Choose a reliable and experienced AR with knowledge of Indonesian medical device regulations.
  • Ensure the AR is registered with BPOM and has the necessary capabilities to represent the manufacturer in all regulatory matters.
  • Formalize the relationship with an agreement that outlines the AR’s role and responsibilities.

2. Prepare the Required Documentation

Collect all necessary documents and ensure they are complete, accurate, and compliant with BPOM’s requirements. Common documents required for Class I registration include:

• Product Description: A detailed description of the device, including its intended use, design, materials, and components.
• Certificate of Free Sale (CFS): Issued by the regulatory authority in the manufacturer’s country of origin, confirming the product is legally sold and marketed in the country of origin.
• ISO 13485 Certification: Demonstrating that the manufacturer has a quality management system in place, as required by international standards.
• Risk Management Documentation: An assessment of the device’s risks (particularly important for devices that are invasive or come into direct contact with the body).
• Clinical Data (if applicable): For devices that involve clinical performance or are associated with therapeutic claims, provide relevant clinical data to support the product's safety and efficacy.
• Device Labeling: Ensure that the product label is in Bahasa Indonesia (the official language of Indonesia), with accurate information, including:
  • Product name, manufacturer details, and contact information.
  • Intended use and warnings.
  • Instructions for use, precautions, and storage conditions.
• Product Testing Reports: If applicable, provide reports for tests such as biocompatibility, electrical safety, sterility, or performance.
• Manufacturing Process Information: Details of the manufacturing processes and quality control measures, including Good Manufacturing Practice (GMP) certification or equivalent.

3. Understand the Classification and Standards

• Classify your device correctly according to BPOM’s classification system, which follows a risk-based approach similar to international guidelines. Class I medical devices are typically low-risk devices.
• Ensure compliance with relevant international standards, such as:
  • ISO 13485 for quality management.
  • ISO 10993 for biocompatibility (if applicable).
  • IEC 60601 for electrical safety (for electrically powered devices).
• Indonesian National Standards (SNI) may apply to certain devices, such as medical gloves or diagnostic kits, so verify if your product needs to meet specific SNI standards.

4. Prepare for Language Requirements

• Labeling and Documentation: All documentation submitted to BPOM, including product labels, instructions for use, and technical specifications, must be translated into Bahasa Indonesia (the official language of Indonesia).
• Consider working with a professional translation service to ensure the accuracy and compliance of the translations.

5. Verify Compliance with Indonesian Import Regulations

• If you plan to import the medical device to Indonesia after registration, make sure you are familiar with the importation regulations:
  • Import License: Ensure that the authorized importer holds the appropriate license for importing medical devices in Indonesia.
  • Customs Requirements: Make sure your product complies with Indonesian customs requirements, including proper HS codes, import duties, and taxes.

6. Develop a Post-Market Surveillance Plan

• BPOM requires ongoing post-market surveillance for medical devices. Before applying for registration, develop a post-market surveillance plan that includes:
  • Procedures for tracking and managing adverse events (e.g., device failures, user injuries).
  • Systems for collecting and reporting complaints and safety incidents.
  • A process for recalling devices if necessary and ensuring compliance with BPOM’s guidelines for post-market actions.

7. Financial and Regulatory Fees

• Registration Fees: Familiarize yourself with the registration fee structure for Class I medical devices. The registration fees may vary depending on the type of product and its complexity. Ensure that you have the necessary budget set aside to cover all regulatory fees, including submission fees to BPOM.
• Payment: BPOM generally requires the registration fees to be paid at the time of submission or prior to approval. Ensure that the payment process is properly managed to avoid delays.

8. Understand the Approval Timeline

• Class I medical devices generally have a shorter approval timeline compared to higher-risk classes. However, you should be prepared for potential delays due to documentation discrepancies or additional requests from BPOM.
• Typical Processing Time: The processing time for Class I devices can vary, but it typically takes around 2-4 months for BPOM to complete the review and approval process. Be prepared for this timeline and plan accordingly.

9. Prepare for Inspections (if applicable)

• Depending on the product and manufacturing processes, BPOM may require facility inspections or audits to verify compliance with Good Manufacturing Practices (GMP) or other regulatory standards.
• If your device is manufactured overseas, BPOM may request additional documentation or inspections to verify manufacturing processes and quality controls. This can include audits of manufacturing sites or third-party testing facilities.

10. Local Regulatory Representation and Communication

• Keep your local authorized representative (AR) informed and involved throughout the process. The AR will act as the primary point of contact for BPOM and will be responsible for submitting and managing all necessary documents and communications with BPOM.
• Ensure that the AR has the necessary expertise and capacity to manage all interactions with BPOM, including handling any requests for additional information or documentation.

Summary of Preparations Before Applying for Class I Medical Device Registration with Indonesia MOH (BPOM):

1. Appoint a Local Authorized Representative (AR) to manage the registration process and ensure ongoing compliance.
2. Prepare Required Documents such as product descriptions, CFS, ISO certifications, clinical data (if applicable), device labeling, and product testing reports.
3. Understand the Classification and Standards to ensure compliance with BPOM’s risk-based classification and relevant international standards (e.g., ISO 13485, ISO 10993).
4. Ensure Labeling and Documentation are translated into Bahasa Indonesia and meet BPOM requirements.
5. Verify Compliance with Import Regulations, including customs requirements and licensing for importers.
6. Develop a Post-Market Surveillance Plan to comply with BPOM’s ongoing monitoring requirements after device approval.
7. Budget for Registration Fees and ensure payment arrangements are in place for submitting the application.
8. Understand the Approval Timeline and plan for possible delays.
9. Prepare for Possible Inspections or audits of your manufacturing facilities if required.
10. Maintain Effective Communication with the AR to ensure smooth submission and regulatory compliance.

By thoroughly preparing these aspects, you will help ensure that your Class I medical device registration with BPOM proceeds smoothly and efficiently.

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