Process, Required Materials, and Key Points for D-Class Medical Device Registration in Indonesia MOH

Registering a D-class medical device in Indonesia involves a detailed process regulated by the Ministry of Health (MOH) and the National Agency of Drug and Food Control (BPOM). The process is aimed at ensuring that medical devices meet safety, quality, and performance standards before they can be marketed and sold in Indonesia.

Here’s a breakdown of the process, the required materials, and the key points for D-class medical device registration:

1. Process for D-Class Medical Device Registration

The registration process for a D-class medical device in Indonesia involves the following key steps:

A. Appoint a Local Authorized Representative

• Requirement: A foreign manufacturer must appoint a local authorized representative or distributor in Indonesia. This entity will be responsible for the submission of the registration application and communication with BPOM.
• Role: The local representative handles all regulatory affairs and ensures compliance with Indonesian regulations.
• Legal Entity: The local representative must be a legally registered business entity in Indonesia.

B. Prepare Required Documentation

• Documents: Gather the necessary documents to support your application. These include the device’s technical, safety, and quality information. The documents must be prepared and submitted in Indonesian or with certified translations where required.
• Quality Compliance: Ensure that the manufacturer complies with ISO 13485 or other internationally recognized quality management standards. While not always mandatory for low-risk devices, it can streamline the process.

C. Submit the Application through BPOM e-Registration System

• Platform: The registration process is done through BPOM’s e-Registration system. The local authorized representative must log into the system to submit the application.
• Forms: Complete the registration application form on the e-Registration system. The form includes detailed information about the device, manufacturer, and distributor.
• Document Submission: Upload all required documents through the system, including:
  • Certificate of Free Sale (CFS)
  • Product description and specifications
  • Risk classification information
  • Labeling and Instructions for Use (IFU)
  • Quality certifications (if applicable)
• Payment: Pay the registration fee via BPOM's online payment system.

D. BPOM Review and Evaluation

• Document Review: BPOM reviews the submitted application and documents to ensure they comply with Indonesian regulations. For D-class devices, the review is typically straightforward.
• Request for Clarifications: If additional information is required, BPOM will request clarification or further documentation.
• Timeline: The review process typically takes 2 to 6 months, depending on the completeness of the application and BPOM’s workload.

E. Issuance of Registration Certificate

• Once BPOM has evaluated the application and documents, and everything is in order, they will issue a Certificate of Registration.
• Validity: The registration certificate is generally valid for 5 years, after which it needs to be renewed.
• Market Access: Upon registration, the device can be marketed and sold in Indonesia, subject to post-market surveillance requirements.

2. Required Materials for D-Class Medical Device Registration

The materials required for D-class medical device registration in Indonesia are primarily technical and administrative documents to prove the device’s safety, efficacy, and regulatory compliance. These include:

A. Certificate of Free Sale (CFS)

• What it is: The CFS is issued by the regulatory authority in the country of origin (e.g., FDA in the USA, CE mark in Europe). It confirms that the medical device is legally sold in the country of manufacture and that it complies with the applicable regulations there.
• Language: The CFS must be in Indonesian or accompanied by a certified translation.

B. Product Information

• Product Description: A detailed description of the device, including its intended use, technical specifications, and design.
• Risk Classification Documentation: Evidence that the device is classified as a D-class medical device in Indonesia (low-risk device).

C. Labeling and Instructions for Use (IFU)

• Labeling Requirements: The product labels and packaging must comply with Indonesian regulations. Labels should include:
  • Device name
  • Manufacturer’s details
  • Country of origin
  • Lot/batch number
  • Expiry date (if applicable)
  • Warnings and precautions
  • Storage instructions
• Language: Labels and IFU must be in Indonesian or include a certified translation.
• IFU: Clear instructions for use, including safety warnings, must be included and in the Indonesian language.

D. Quality Management System (QMS) Documentation

• While ISO 13485 or similar certifications are not always mandatory for D-class devices, providing evidence of a quality management system is beneficial and may help expedite the registration process.
• Evidence of Compliance: Include documentation such as ISO certificates or similar quality assurance documents.

E. Importation and Distribution Documentation

• Distributor Registration: Documentation related to the local distributor or representative, such as:
  • Business registration or SIUP (Surat Izin Usaha Perdagangan) for the distributor.
  • A signed agreement between the manufacturer and the local distributor, confirming their authority to handle the device registration and marketing.

F. Other Regulatory Documents (If Applicable)

• If the device has received any other regulatory approvals or certifications (e.g., CE mark, FDA approval), these documents should also be included to support the application.

3. Key Points to Consider for D-Class Medical Device Registration

A. Compliance with Indonesian Regulations

• Ensure that the device meets Indonesian National Standards (SNI) for medical devices, if applicable. Though D-class devices are low risk, they still need to comply with the basic safety and performance standards in Indonesia.
• Make sure that all documentation is complete, accurate, and in the Indonesian language or accompanied by certified translations.

B. Local Authorized Representative Requirement

• A local representative or distributor is a legal requirement for foreign manufacturers wishing to register a medical device in Indonesia. The representative must handle the submission and communicate with BPOM.

C. Documentation and Translation

• All documents, including the product description, IFU, and labeling, must be in Indonesian or accompanied by certified translations. This is a critical point for compliance.

D. Registration Fee

• D-class devices have relatively lower registration fees compared to higher-risk devices, typically ranging from IDR 5,000,000 to IDR 10,000,000 (approximately USD 300 to USD 650). Be prepared to pay the registration fee during the submission process through the e-Registration portal.

E. Post-Market Surveillance

• After the device is registered and marketed, the local distributor must comply with post-market surveillance requirements. This includes monitoring the device's performance, handling adverse events, and ensuring ongoing compliance with regulations.

4. Timeline for D-Class Medical Device Registration

• Application Submission: Submit the application via BPOM’s e-Registration system.
• Review Process: BPOM typically takes 2 to 6 months for review, depending on the completeness of the application and their workload.
• Registration Issuance: Upon approval, BPOM issues a Registration Certificate that allows the device to be sold in Indonesia. The certificate is valid for 5 years.

By ensuring thorough documentation, compliance with Indonesian regulations, and proper use of the BPOM e-Registration system, the process of registering a D-class medical device in Indonesia can be completed efficiently. It’s advisable to work closely with a local authorized representative to ensure a smooth registration experience.

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