The process of registering Class II medical devices with the Indonesian Ministry of Health (MOH), specifically through the National Agency of Drug and Food Control (BPOM), involves several key steps and procedures. Here's an overview of the registration procedure:

1. Classify the Device

• Ensure that your device qualifies as a Class II medical device under Indonesian regulations. Class II devices are typically low to moderate risk and include devices such as diagnostic tools, certain surgical instruments, and patient monitoring systems.
• Refer to BPOM's classification guidelines or consult a local regulatory expert to confirm the device classification.

2. Appoint a Local Authorized Representative (AR) or Importer

• If you're a foreign manufacturer, you must appoint a local authorized representative (AR) or authorized importer in Indonesia. This entity will act as the liaison between BPOM and your company.
• The AR or importer is responsible for submitting the registration application and ensuring that the device complies with Indonesian regulatory requirements.

3. Prepare Required Documents

Ensure that the following documents are prepared for submission:

• Cover Letter: A letter from the manufacturer or authorized representative detailing the intent to register the device.
• Product Description: A comprehensive description of the medical device, including its intended use, features, and technical specifications.
• Certificate of Free Sale (CFS): A certificate from the country of origin proving that the device is legally marketed in that country.
• Manufacturing License (if applicable): A certificate from the country of manufacture showing that the manufacturer is licensed to produce medical devices.
• ISO 13485 Certificate: Evidence that the manufacturer complies with quality management standards for medical device manufacturing.
• Clinical Evaluation Report (CER): A report that provides evidence of the clinical safety and performance of the device (if applicable).
• Risk Management Report: A document demonstrating compliance with ISO 14971, outlining how risks associated with the device are identified and mitigated.
• Labeling and Instructions for Use (IFU): All product labeling and user manuals must be in Bahasa Indonesia and meet local requirements.
• Regulatory Application Form: Complete BPOM's official registration form, which requires details about the device and the company.

4. Submit Application to BPOM

• The registration application can be submitted either electronically via BPOM's e-registration system or physically at BPOM's office, depending on the specific requirements.
• Ensure that all documents are in the correct format and include accurate translations where necessary (e.g., the product label and instructions for use must be in Bahasa Indonesia).

5. Application Review by BPOM

BPOM will perform a thorough review of your application. This review typically includes:

• Document Verification: BPOM will verify that all required documents are submitted and complete.
• Technical Evaluation: BPOM evaluates the device’s compliance with technical standards and regulatory requirements.
• Safety and Performance Evaluation: The agency assesses the safety and performance of the device based on available clinical evidence (Clinical Evaluation Report).
• Labeling and IFU Review: BPOM checks whether the labeling and instructions for use comply with local regulations, including the requirement to have them in Bahasa Indonesia.

6. Factory Inspection (If Required)

• Depending on the device and its risk profile, BPOM may conduct a factory inspection to ensure that the manufacturer complies with Good Manufacturing Practices (GMP) and other applicable standards.
• Inspections are more common for locally manufactured devices or if BPOM deems it necessary for high-risk devices.

7. Registration Approval

• Once BPOM completes its review and is satisfied with the documentation, the registration certificate (Surat Tanda Pendaftaran, STP) will be issued. This certificate formally authorizes the device for sale and distribution in Indonesia.
• The registration certificate is typically valid for 5 years. After this period, renewal is required to keep the product on the market.

8. Post-Market Surveillance Requirements

• After obtaining registration, manufacturers and their local representatives must comply with Indonesia's post-market surveillance obligations, including:
  • Reporting any adverse events or device-related incidents.
  • Monitoring the device's performance in the market.
  • Reporting significant changes to the device’s design, labeling, or intended use to BPOM.
  • Cooperating with BPOM during periodic audits or inspections.

Key Notes:

• Translation Requirements: Ensure all documentation and labeling (including Instructions for Use and Product Labels) are translated into Bahasa Indonesia.
• Product Variants: If your device has multiple variants, each variant must be registered separately.
• Quality Management System (QMS): Devices should be manufactured in facilities that are certified under ISO 13485 or similar standards for medical device quality management.
• Clinical Data: If required, clinical data supporting the safety and performance of the device should be included. This is particularly important for devices that are novel or have a higher level of risk.
• BPOM Fees: Registration fees are typically applicable and may vary depending on the type of device.

Estimated Timeline for Class II Registration:

• The typical registration timeline for a Class II medical device is approximately 3 to 6 months, depending on the completeness of the application, BPOM’s workload, and whether any additional information or inspections are required.

Contact Information for BPOM:

• National Agency of Drug and Food Control (BPOM), Indonesia.
• For up-to-date information or specific queries, it is advisable to consult BPOM’s official website or work with a local regulatory expert.

Would you like more information on any particular step or specific advice related to your product?

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