Yes, annual renewal is required for the Class C medical device registration in Indonesia under the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control).

Annual Renewal Process:

• Registration Validity: Once a Class C medical device is registered, the Marketing Authorization Number (NOM) is valid for a specific period, typically 5 years from the date of issuance.
• Renewal Requirement: Before the expiration of the initial 5-year period, the device's registration must be renewed annually.
• Process:
  • The renewal process involves submitting a renewal application to BPOM through the e-Registration system.
  • The renewal application includes updating any necessary documentation and confirming that the device still meets all regulatory requirements.
  • There is typically no need for a full resubmission of technical documentation unless there have been changes to the device, its manufacturer, or its intended use.

Key Aspects of Annual Renewal:

1. Documentation Update: Manufacturers may need to provide updated documentation, such as:

   • Product information, including any changes in labeling, intended use, or design.
   • Manufacturing details: If there have been changes in the manufacturing process or location, this needs to be reported.
   • Clinical data (if applicable): Any new clinical trials or performance data that has emerged since the last registration or renewal.
   • Quality Management System (QMS): Proof of continuous compliance with ISO 13485 and other applicable standards.

2. Post-Market Surveillance: BPOM may request a report on the device's performance in the market, including any adverse events, complaints, or corrective actions taken since the last renewal.

3. Fee Payment: The renewal process will involve the payment of a renewal fee, which is usually lower than the initial registration fee.

4. Inspection and Compliance: BPOM may request a GMP inspection or ask for evidence that the manufacturer continues to comply with regulatory requirements. This is more likely if there have been significant changes to the device or if new risks are identified.

Why Annual Renewal is Important:

• Ongoing Compliance: Annual renewal ensures that the medical device continues to meet the regulatory requirements set by BPOM, including safety, effectiveness, and quality standards.
• Market Safety: The renewal process also ensures that the device is still safe for use, particularly if there have been updates to regulatory requirements or post-market surveillance data.
• Preventing Market Disruption: Failure to renew the registration in time can result in the device being removed from the market, causing disruptions in availability and potential legal issues for the manufacturer or distributor.

In summary, annual renewal is required to maintain the validity of Class C medical device registration in Indonesia. This ensures that the device continues to meet the necessary regulatory standards for safety and efficacy and remains authorized for sale and distribution in the Indonesian market.

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