What is China’s Medical Device Business License and Who Needs One?

The Medical Device Business License (医疗器械经营许可证), sometimes also referred to as the Medical Device Trading Permit and Filing (医疗器械经营备案), are permits for businesses engaging in medical device sales and distribution in China. Issued by local Food and Drug Administration bureaus under the National Medical Products Administration (NMPA), these permits are required for companies selling, importing, or distributing medical devices across all risk categories. For foreign businesses targeting China’s rapidly expanding healthcare market, securing the appropriate license or filing is critical to ensure regulatory compliance and establish credibility with healthcare providers and consumers. At AppInChina, we provide expert guidance to navigate this complex regulatory framework, helping you establish a compliant and successful medical device business in China.

What is the Medical Device Business License?

The Medical Device Business License authorises businesses to engage in commercial medical device operations, as regulated under the Medical Device Supervision and Administration Regulation. This includes the sale, distribution, import, and storage of medical devices classified into three risk categories: Class I (low risk), Class II (moderate risk), and Class III (high risk). Class I devices require only business filing (备案), Class II devices require business license application, and Class III devices require both business licenses and additional qualification requirements. Valid for five years, licenses require renewal applications to be submitted within 90 days before expiry. Any business commercialising medical devices in China, whether through direct sales, e-commerce platforms, or distribution partnerships, must obtain the appropriate license to operate legally and comply with local requirements.

Why Do You Need This License?

The Medical Device Business License ensures your business complies with China’s strict medical device regulations. The license number must be prominently displayed on business premises, websites, and marketing materials. Operating without a Medical Device Business License carries severe penalties, including fines ranging from 50,000 to 500,000 RMB for unlicensed operations, mandatory cessation of business activities, and potential confiscation of all illegal revenue. Additionally, unlicensed operators may face criminal liability and permanent industry bans under China’s Medical Device Administration regulations.

Who Needs the Medical Device Business License?

Any business selling or distributing medical devices in China requires the appropriate license or filing based on device risk level. This includes medical device importers and distributors handling hospital equipment, surgical instruments, or diagnostic devices; e-commerce platforms selling medical supplies directly to consumers or healthcare facilities; medical equipment rental and leasing companies; healthcare service providers purchasing devices for clinical use; and international medical device manufacturers establishing sales operations in China. Companies engaged in medical device maintenance, calibration, or technical support services may also require licensing depending on their scope of operations. Businesses selling only Class I low-risk devices (such as basic surgical instruments or simple diagnostic tools) only need the medical device business filing (医疗器械经营备案), while those handling Class II or III devices require full licensing with additional qualification requirements and facility inspections.

How Can I Obtain This License?

Securing a Medical Device Business License involves a comprehensive process with strict technical and facility requirements. The fundamental requirement is establishing a legal entity in China with qualified personnel and appropriate storage facilities. Applications are submitted to local Food and Drug Administration bureaus and undergo a 30-45 day review process, including on-site facility inspections for Class II and III device licenses. For domestic companies, the complete process takes 2-3 months and costs between RMB 30,000 and 50,000, depending on device classification and regional variations.

The application requires the following comprehensive documentation:

Required Application Documents:

1. Application Form for Medical Device Business License (must be signed by legal representative and stamped with official seal)
2. Copy of business license (营业执照) and articles of association (business scope must specifically include medical device operations)
3. Certificate of legal representative and quality management personnel qualifications
4. List of medical device products intended for business operations
5. Organizational structure and personnel management system documentation
6. Quality management system and standard operating procedures
7. Facility layout plans and storage condition specifications
8. Equipment list and calibration certificates for storage and testing equipment
9. Supplier qualification verification and product traceability procedures
10. Emergency response plans and adverse event reporting systems

Critical Application Requirements:

• All application materials must be complete, clear, and bound in specified order on A4 paper
• Each document requiring signatures must be individually signed and stamped with official company seal
• Photocopies must be dated and stamped with enterprise’s official seal
• Enterprise name and address must match exactly with business license
• Business site and warehouse areas must meet regulatory size requirements for intended scope
• Operation mode must specify “wholesale,” “retail,” or “wholesale and retail” (specialized transportation/storage services can be selected separately)
• Identity cards, education certificates, and appointment documents for legal representative, enterprise heads, and quality management personnel must be complete and valid
• Warehouse property ownership certificates or valid lease agreements required (for entrusted storage, entrustment agreements must clearly define quality responsibilities)
• When applying for Class III device license and Class II device filing simultaneously, Class II filing documentation may be waived

Additional Supporting Documentation:

• Detailed business plan outlining medical device operations
• Financial statements and registered capital verification
• Proof of warehouse and office space usage rights
• Temperature and humidity monitoring system documentation
• Staff training records and continuing education certificates
• Product liability insurance and quality assurance documentation
• Import/export qualification certificates if applicable

Personnel Requirements:

• Quality management personnel with medical device or pharmaceutical education background
• Technical support staff with relevant professional qualifications
• Training documentation for all personnel handling medical devices

Licensed businesses must maintain detailed records of all transactions, implement traceability systems, and may need supplementary permits such as an Import/Export Medical Device License for international trade operations. After successfully applying for and receiving the license, you can access the license database and search for your license number to ensure your license has been processed. AppInChina streamlines this complex process, managing all documentation requirements, facility preparation guidance, and regulatory coordination to ensure successful licensing.

Can I Obtain this License as a Foreign Company?

Wholly Foreign-Owned Enterprises (WFOEs) cannot obtain Medical Device Business Licenses due to foreign investment restrictions in healthcare services. Foreign companies must establish partnerships with qualified Chinese entities, such as AppInChina, or implement joint venture structures to access this market legally. For domestic Chinese companies, the business scope must be specifically related to medical devices, and this must be clearly stated in the company’s business license registration.

Additional challenges include complex device classification requirements, mandatory Chinese labeling and documentation, and strict import registration procedures for foreign-manufactured devices. The regulatory landscape requires deep understanding of China’s medical device laws, product registration requirements, and post-market surveillance obligations. AppInChina offers comprehensive solutions, including local entity establishment, facility setup guidance, personnel recruitment and training, and complete regulatory compliance support to ensure your medical device business meets all Chinese standards while maintaining operational efficiency.

How Can AppInChina Help?

AppInChina provides comprehensive end-to-end services to secure your Medical Device Business License and establish a successful presence in China’s healthcare market. Our experienced team manages the entire licensing process, from initial consultation and business entity setup to facility preparation, documentation submission, and post-approval compliance support.

Ready to enter China’s healthcare market? Contact us today to secure your Medical Device Business License and establish a compliant, successful healthcare business in China.

Sources:

https://www.nmpa.gov.cn/ylqx/ylqxfgwj/ylqxbmgzh/20171121171601668.html?type=pc&m=

https://appinchina.co/government-documents/measures-on-supervision-and-administration-of-business-operations-of-medical-devices-2022measures-on-supervision-and-administration-of-business-operations-of-medical-devices-2022measures-on-superv