The process for registering Class C medical devices with BPOM (Badan Pengawas Obat dan Makanan), the Indonesian Ministry of Health (MOH), is continually evolving to align with international best practices and ensure patient safety. The latest updates to standards and processes typically reflect changes in regulatory frameworks, evolving international guidelines (such as ISO standards), and specific updates to BPOM regulations.

Here is an overview of the updated standards and processes for Class C medical device registration in Indonesia, based on the latest available guidelines and regulatory requirements.

1. Regulatory Framework for Medical Device Registration in Indonesia

The regulatory framework for Class C medical devices has been outlined in several key BPOM regulations and related guidelines:

• Regulation No. 27 of 2017: This is the primary regulation governing the registration of medical devices in Indonesia. It covers all classes of medical devices and establishes the processes for registration, licensing, and post-market surveillance.
• Regulation No. 84 of 2018: This regulation specifies labeling requirements for medical devices, including requirements for the Indonesian language (Bahasa Indonesia) on labels, user instructions, and packaging.
• BPOM Circular Letter: BPOM periodically issues circular letters that provide additional guidelines, updates, and clarifications on specific issues (e.g., clinical data requirements, GMP certifications).

The most recent regulatory updates are often communicated through these channels. It’s essential to monitor any changes published by BPOM.

2. Classification of Medical Devices

Class C medical devices in Indonesia are defined as those that pose moderate to high risks to patients but are not considered the highest risk (which is the Class D category).

• Class C includes devices such as diagnostic equipment, surgical instruments, and other devices that have a significant risk if they fail but are typically used under controlled conditions.
• These devices require substantial documentation to demonstrate safety, effectiveness, and compliance with regulatory standards.

3. Updated Registration Process for Class C Medical Devices

The process of registering a Class C medical device in Indonesia involves several critical steps. The updated process includes the following:

Step 1: Determine Eligibility and Classify the Device

• Device Classification: Verify that the device is correctly classified as Class C. BPOM classifies medical devices into four classes (Class I to Class D) based on risk. For Class C devices, more comprehensive documentation is required.
• Authorized Representative: If you are a foreign manufacturer, appoint a local authorized representative (distributor) who will submit the registration on your behalf.

Step 2: Prepare the Required Documents

Key documents required for Class C medical device registration are:

• Device Description: Clear description of the device, including intended use, indications, and contraindications.
• Risk Management Plan: A detailed risk management document that follows ISO 14971 to evaluate and mitigate any risks associated with the device.
• Clinical Evidence: If required, submit clinical trial data or other evidence supporting the device’s safety and effectiveness. For Class C, clinical data may be needed to substantiate claims about performance and safety.
• ISO Certifications: Proof of compliance with ISO 13485 (Quality Management Systems for Medical Devices) and other relevant international standards.
• Manufacturing and GMP Certification: Ensure that your manufacturing facility complies with Good Manufacturing Practices (GMP). BPOM may require GMP certification from the relevant health authority of the country of manufacture (e.g., FDA or EMA).
• Labeling and Packaging Information: Labels must comply with BPOM’s requirements (Regulation No. 84/2018), including Bahasa Indonesia labeling and user instructions.

Step 3: Submit the Registration Application

• BPOM Online Portal: The registration application must be submitted through BPOM’s online e-Registration system. This system allows for the submission of all documents and is used to track the registration process.
• The authorized representative (if applicable) will be the primary contact for BPOM throughout the registration process.

Step 4: BPOM Review and Evaluation

• Evaluation: BPOM will review all submitted documents and may request additional information or clarifications.
• Technical Evaluation: BPOM evaluates the device’s technical documentation, including clinical data, device safety, and quality assurance.
• Risk Assessment: A comprehensive assessment of risks associated with the device is conducted. This includes an evaluation of potential side effects, device failures, and complications.

Step 5: Approval and Issuance of Registration

• After successful evaluation, BPOM issues the Marketing Authorization (Marketing Authorization Number or NOM). This allows the device to be marketed in Indonesia.
• You will also receive a certificate that validates the device's regulatory approval in Indonesia.

4. Updated Standards for Medical Devices

In terms of standards, BPOM aligns with various international guidelines to ensure safety, quality, and efficacy. Some updated standards include:

a. ISO 13485:2016 – Quality Management Systems (QMS)

• This ISO standard is mandatory for manufacturers of Class C devices, and BPOM requires proof of compliance to ensure that medical devices are manufactured under an effective quality management system.

b. ISO 14971:2019 – Risk Management for Medical Devices

• The risk management process is critical for all medical devices. Manufacturers must provide a Risk Management Plan that complies with ISO 14971, identifying and mitigating any potential risks associated with the device during its lifecycle.

c. ISO 10993-1:2018 – Biocompatibility Testing

• Devices that come into direct or indirect contact with the human body must comply with ISO 10993 for biocompatibility testing to ensure that materials used in the device do not cause harm or adverse reactions in users.

d. Clinical Data and Evidence

• ISO 14155:2020 outlines the standards for clinical trials of medical devices, ensuring that clinical data submitted in support of a device's registration is gathered and analyzed according to internationally recognized methodologies.

5. Post-Market Surveillance and Reporting

After the device is registered, manufacturers and distributors are required to:

• Monitor Device Performance: Continuous monitoring of the device’s performance in the market is essential. Any adverse events or product issues must be reported to BPOM immediately.
• Adverse Event Reporting: Serious incidents involving the device must be reported within 10 days. For non-serious events, BPOM requires a 6-monthly report of post-market surveillance findings.
• Product Recalls: If safety concerns arise, BPOM may initiate a product recall. Manufacturers must have a system in place for product recall and corrective action.

6. GMP Compliance and Inspections

BPOM requires all manufacturers to maintain compliance with Good Manufacturing Practices (GMP). This includes periodic inspections of manufacturing sites to verify that the facilities continue to meet regulatory standards.

• Foreign Manufacturers: BPOM may require inspection certificates from the home country’s regulatory body (e.g., FDA or EMA) to confirm GMP compliance.
• Inspection and Audits: BPOM may inspect the manufacturing facility at any time and can impose fines or penalties for non-compliance.

7. Renewal and Maintenance of Registration

• Device Registration Validity: The initial registration is valid for 5 years. Before expiration, the manufacturer must apply for renewal.
• The renewal application typically includes updated clinical safety data, GMP certificates, and a post-market surveillance report.

8. Updates to Fees

• Regulatory Fees: There may be updated registration fees, renewal fees, and inspection fees. These are subject to change and should be reviewed periodically on BPOM’s official website or via the e-Registration system.

Summary of Key Updates:

1. Regulatory Framework: The latest regulations under Regulation No. 27 of 2017 and Regulation No. 84 of 2018 govern the registration process for medical devices in Indonesia.
2. Submission Process: The registration process is now fully digital through BPOM’s e-Registration system.
3. Updated Standards: Compliance with ISO 13485 (QMS), ISO 14971 (risk management), and ISO 10993 (biocompatibility) is mandatory for Class C devices.
4. Post-Market Requirements: Ongoing post-market surveillance, adverse event reporting, and product recalls are critical components of regulatory compliance.
5. GMP Compliance: Continued adherence to Good Manufacturing Practices and potential inspections of manufacturing facilities.

By staying up-to-date with these standards and following the updated registration process, you can ensure that your Class C medical device meets BPOM’s regulatory requirements and remains compliant in the Indonesian market. If you need assistance with any specific step or document preparation, feel free to ask!

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn