Class A medical device registration with Indonesia's Ministry of Health (MOH) refers to the process of obtaining official approval for medical devices that are classified as low-risk. These devices are considered to pose minimal risk to users and patients, and therefore the regulatory requirements are generally less stringent than those for higher-risk devices (Class B, C, or D).

In Indonesia, Class A devices must be registered with the Ministry of Health (MOH) or the National Agency of Drug and Food Control (BPOM) before they can be marketed or sold. The registration process ensures that the device complies with local regulations concerning safety, efficacy, and quality.

Key Points About Class A Registration:

1. Low Risk: Class A devices are typically non-invasive, such as bandages, simple surgical tools, and basic diagnostic devices.
2. Simplified Process: The registration process is more straightforward and faster compared to higher-risk devices.
3. Documentation Requirements: Basic documentation is required, such as product descriptions, evidence of compliance with international standards (e.g., ISO 13485), and proof of safety.
4. Registration: Successful registration results in the issuance of a Izin Edar (distribution license) that allows the device to be sold and distributed in Indonesia.

Overall, Class A medical device registration ensures that low-risk devices meet safety standards before being introduced into the Indonesian market.

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