Medical Device Registration Classification and Filing/Registration Process Guide

Medical devices are managed in three classes by risk level, with significantly different market access requirements. Enterprises must accurately classify products and select the corresponding filing or registration path.

1. Classification Management

Class I medical devices (low risk, e.g., stethoscopes, medical magnifiers) are subject to filing management. Class II medical devices (moderate risk, e.g., thermometers, blood pressure monitors, medical masks) are subject to registration, approved by provincial drug administration departments. Class III medical devices (higher risk, e.g., implantable cardiac pacemakers, artificial joints) are subject to registration, approved by the National Medical Products Administration.

2. Class I Filing Process

Both Class I product filing and production filing are handled by the municipal drug administration department at the prefecture level. Filing requires: filing form, product risk analysis materials, product technical requirements, product test report, clinical evaluation materials, product instructions and label drafts, and manufacturing information. Filing certificates are valid indefinitely; changes to filing information require filing modification.

3. Class II/III Registration Process

Process: product development (design and development, risk management) → registration testing (submit to qualified medical device testing institution) → clinical evaluation (submit clinical evaluation materials if exempt from clinical trials; conduct clinical trials if required) → submit registration application → technical review (60 working days, may issue supplementary requests) → administrative approval (20 working days) → registration certificate issuance. Certificates are valid for 5 years.

4. Registration Certificate Maintenance

To renew before expiration, application must be submitted 6 months before expiry. Registration item changes (registrant name, address, production address) require registration modification; licensing item changes (product name, model/specification, structural composition, intended use, etc.) require modification registration. Registrants must establish a quality management system and accept supervisory inspections from regulatory authorities.