The purpose of applying for Class C medical device registration in Indonesia under the Ministry of Health (MOH) is primarily to ensure that medical devices meet the necessary regulatory standards for safety, efficacy, and quality before they are allowed to be marketed, distributed, or used in the country. Registration helps protect public health and patient safety by ensuring that only approved, compliant devices are available for use in healthcare settings.

Key Purposes of Class C Medical Device Registration:

1. Ensuring Patient and User Safety

• Class C devices are considered moderate-risk, meaning they may have a higher potential to harm patients or users compared to low-risk devices. The registration process ensures that these devices:
  • Are safe to use under intended conditions.
  • Meet performance standards that reduce the likelihood of adverse events.
  • Are manufactured following proper quality control procedures.

2. Compliance with National Regulations

• Indonesia, through its Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control), mandates that all medical devices (including Class C) undergo a rigorous registration process to comply with national laws and regulations.
  • The registration confirms that the device meets the standards set by BPOM and complies with international quality standards like ISO 13485 (Quality Management Systems) and ISO 14971 (Risk Management).

3. Legal Authorization to Market and Distribute in Indonesia

• A key purpose of registration is to gain legal authorization for the marketing and distribution of the medical device in Indonesia. Without registration, it is illegal to sell or distribute medical devices in the country.
  • Class C registration provides the Marketing Authorization Number (NOM), which is the official approval for manufacturers and importers to legally commercialize their devices in Indonesia.

4. Facilitating Access to a Growing Medical Market

• Indonesia is one of the largest and most dynamic medical device markets in Southeast Asia, and obtaining Class C registration opens the door to this market. For foreign manufacturers, it is essential to have local registration to distribute and sell products in Indonesia.
  • By registering a device with BPOM, manufacturers can tap into the growing demand for medical devices in hospitals, clinics, and healthcare facilities across Indonesia.

5. Transparency and Consumer Protection

• The registration process adds an element of accountability to the medical device supply chain. BPOM ensures that only devices meeting the necessary safety and performance standards are approved for use in Indonesia.
  • This process helps protect consumers (patients and healthcare professionals) by ensuring that medical devices are thoroughly assessed before being sold in the market.

6. International Recognition and Confidence

• Having a registered Class C medical device in Indonesia can serve as a signal of quality assurance to other markets and regulatory authorities. Meeting the standards of BPOM may help facilitate the process of registering the device in other countries, improving the manufacturer’s global marketability.
  • Some foreign manufacturers may find that registering their product in Indonesia enhances their credibility in other Southeast Asian markets as well.

7. Post-Market Surveillance and Accountability

• After the registration process, there is an ongoing responsibility for post-market surveillance. This ensures that the device continues to meet safety standards and that any adverse events or issues are reported to BPOM for appropriate action.
  • The registration gives BPOM the authority to monitor the device's performance, ensuring that any future problems can be addressed, and the public health is safeguarded.

In Summary:

The primary purpose of applying for Class C medical device registration in Indonesia is to ensure that the device is safe, effective, and compliant with local regulations. The registration process provides the manufacturer with the legal right to market and distribute the device in Indonesia, ensures public health protection, and supports transparency, consumer confidence, and international market access.

Contact Us：

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