The registration process for Class II medical devices with the Indonesian Ministry of Health (MOH), through the National Agency of Drug and Food Control (BPOM), involves several key steps. Below is a detailed overview of the process:

1. Determine Product Classification

• First, confirm that your device qualifies as a Class II medical device under Indonesia’s regulatory framework. Class II devices are those that are considered to have a moderate level of risk.
• If unsure, consult BPOM’s classification guidelines or get assistance from a local regulatory expert.

2. Appoint a Local Authorized Representative or Importer

• If you are a foreign manufacturer, you must appoint a local authorized representative (AR) or authorized importer in Indonesia. This entity will be the point of contact for BPOM and handle the registration on your behalf.
• The AR or importer is responsible for ensuring compliance with all regulatory requirements and for maintaining communication with the authorities.

3. Prepare Required Documentation

You will need to prepare and gather the following documents for submission:

• Cover letter from the manufacturer or authorized representative.
• Product Description: Detailed description of the medical device, including its intended use, features, and specifications.
• Certificate of Free Sale (CFS): A certificate from the country of origin, proving that the device is legally sold and used there.
• Manufacturing License (if applicable): From the country where the device is manufactured.
• Quality Management System (QMS) Certificate: ISO 13485 certification or equivalent showing the manufacturer follows good manufacturing practices.
• Clinical Evaluation Report (CER): Evidence of the clinical safety and efficacy of the device, if applicable.
• Risk Management Report: A document showing how risks related to the device are identified and mitigated (e.g., in compliance with ISO 14971).
• Labeling: Product labeling and instructions for use (IFU) in Bahasa Indonesia.
• Registration Application Form: Fill out the required form with product and company details.

4. Submit Registration Application

• Online Submission: The application must be submitted through the e-registration system provided by BPOM. Alternatively, the documents can be submitted to BPOM physically, depending on the specific requirements.
• Ensure that all documents are complete, in the correct format, and translated into Bahasa Indonesia where required (such as labeling and instructions for use).

5. Document Review by BPOM

BPOM will conduct a review of the submitted documents for completeness, accuracy, and compliance with local regulations. This may involve:

• Technical Review: BPOM evaluates the technical aspects of the device, including risk management, safety, and performance data.
• Labeling and IFU Review: BPOM checks that the labeling and instructions meet Indonesian language requirements and local regulations.

6. Factory Inspection (If Applicable)

• Depending on the type of device, BPOM may request a factory inspection to verify that manufacturing processes comply with Indonesian standards.
• This is more common for devices that pose higher risks or are being manufactured locally.

7. Issuance of Registration Certificate (Surat Tanda Pendaftaran or STP)

If the application is approved, BPOM will issue the Registration Certificate (STP), which authorizes the sale and distribution of the Class II device in Indonesia. The registration certificate is valid for 5 years from the date of issuance.

• The STP is required for the importation and sale of the device in Indonesia.

8. Post-Market Surveillance and Reporting

After obtaining the registration certificate, the device is authorized for sale in the Indonesian market. However, the manufacturer (or their local representative) must comply with post-market surveillance requirements, including:

• Reporting any adverse events or device malfunctions.
• Updating BPOM with any changes to product information, manufacturing processes, or labeling.
• Periodic audits or inspections by BPOM may occur to ensure continued compliance.

Timeline for Registration:

The entire process of registering a Class II medical device with BPOM typically takes between 3 to 6 months, depending on the complexity of the device, completeness of the application, and BPOM's workload.

Notes:

• Language Requirement: All technical documentation and labeling (including instructions for use) should be translated into Bahasa Indonesia.
• Product Variants: If your device has multiple variants, each variant must be registered separately.
• Product Testing: Depending on the device, additional testing or documentation may be required, particularly if the device is novel or involves complex technology.

Key Contacts:

• BPOM: The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan), which is responsible for the regulation of medical devices in Indonesia.
• Local Authorized Representative (AR): Must be a legally registered entity in Indonesia that can submit applications on behalf of foreign manufacturers.