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Summary of Medical Device License Requirements in China
In the Chinese market, medical devices are systematically categorized into three classes—Class I, Class II, and Class III—according to their risk levels. Each class is subject to specific regulatory management. Here’s a detailed breakdown:
1. Key Steps Overview
Product Classification: Determine whether your product belongs to Class I, Class II, or Class III.
License Application: Apply for the appropriate business operation or production licenses based on the product class.
Production Procedure: Register your product before applying for the production license.
Compliance: Adhere to Good Manufacturing Practice (GMP) and Good Supply Practice (GSP), and be ready for regular inspections by medical products regulatory authorities.
2. Classification and License Requirements
Class | Risk Level | Common Examples | Business Operation Requirements | Production Requirements |
Class I | Low Risk | Gauze, Bandages | No business operation license; filing only | Production filing (no production license) |
Class II | Moderate Risk | Thermometers, Blood Pressure Monitors | Most need 《Medical Device Business Operation Filing Certificate》; some high-risk items require a license | 《Medical Device Production License》 required |
Class III | High Risk | Cardiac Stents, Implantable Materials | 《Medical Device Business Operation License》 required | 《Medical Device Production License》 required |
2.Application Process
1.Business License: Ensure “medical device operation” is included in your business scope.
2.Submit Application:
Class II: File the 《Medical Device Business Operation Filing Form》 with the municipal medical products regulatory authority.
Class III: Submit the 《Medical Device Business Operation License Application Form》 to the provincial medical products regulatory authority.
Inspection: Only Class III applications undergo on - site inspections to check premises, equipment, and personnel qualifications.
3.License Issuance:
Class II: Receive the 《Medical Device Business Operation Filing Certificate》 (no expiration date).
Class III: Get the 《Medical Device Business Operation License》 upon approval (valid for 5 years).
3.Processing Time
License Type | Duration |
Class II Business Operation Filing | 5 - 10 working days |
Class III Business Operation License | 20 - 30 working days |
4. Important Notes
Online Sales: If selling via e - commerce platforms (e.g., Tmall, JD.com), “online sales” must be specified in your license, with additional filing required.
Imported Devices: An extra 《Imported Medical Device Registration Certificate》 is necessary.
Penalties: Unauthorized operation of Class III devices can lead to fines up to 20 times the goods’ value, and criminal charges if applicable
5. FAQs
Q: Do I need a license to operate household medical devices, like blood glucose meters?
A: For Class II items (e.g., electronic blood pressure monitors), filing is required. For Class III devices (e.g., continuous glucose monitors), a business operation license is needed.
Q: Is a production license required for Class I medical devices?
A: Only production filing is needed, but strict compliance with filing requirements is essential.
Q: What’s the license validity period, and how to renew?
A: Both business operation and production licenses are valid for 5 years. Apply for renewal 6 months before expiration.
For more details or tailored guidance, feel free to contact us.
