Medical Device Business License Application in China

FINERISE assists medical device operators in obtaining the necessary permits and filings under the Medical Device Operation Supervision and Management Measures (latest revision). We support Class III Medical Device Operation Permit applications and Class II medical device filings — enabling your business to legally engage in medical device distribution in China.

Class I Medical Device

No permit or filing is required for Class I medical device operations. Only a valid business license is needed.

Products: surgical instruments, bandages, stethoscopes, etc.
Lowest risk level under China's classification system
No additional application to NMPA or local authorities

Class II Medical Device

Class II medical device operations require filing with the local drug administration authority. Some products may be exempt from filing.

Products: diagnostic reagents, pregnancy test kits, hearing aids, etc.
Filing completed online via the local authority's service platform
No on-site inspection required for filing in most cases

Apply for Class II Filing >

Class III Medical Device

Class III medical device operations require a full operation permit (license) issued by the municipal drug administration authority.

Products: implants, pacemakers, ventilators, etc.
Requires on-site inspection and strict compliance with GSP standards
License valid for 5 years

Apply for Class III License >

Medical Device Classification Under NMPA

[Class I]

Low Risk

No license or filing required. Business license only.

[Class II]

Moderate Risk

Filing required. Online submission to local authority.

[Class III]

High Risk

License required. On-site inspection and GSP compliance.

[Note]

Exemption

13 product categories exempt from Class II filing.

≡ Key Regulatory Basis

The Medical Device Operation Supervision and Management Measures were revised and issued by the National Medical Products Administration (NMPA). The current version incorporates "放管服" (streamline administration, delegate power, improve regulation and upgrade services) reforms. Key features include:

- Classification management – Class I (no permit/filing), Class II (filing), Class III (permit).
- Reduced filing requirements – Businesses that only sell pre-packaged medical devices may be exempt from full filing requirements for certain Class II products. The NMPA has announced 13 categories of Class II medical devices that are exempt from filing.
- Simplified material submission – For companies that have already obtained a Class III permit, filings for Class II may be exempt from submitting duplicate materials. For those applying for both Class III and Class II simultaneously, materials may be submitted once and on-site inspections conducted together. The "营业执照复印件" and "其他证明材料" requirements for licensing and filing applications have been abolished under the reform.
- Reduced review period – The review period has been reduced from 30 working days to 20 working days.

≡ Who Needs a Medical Device Operation Permit or Filing?

- Wholesalers of Class III medical devices – must obtain a Medical Device Operation Permit.
- Retailers of Class III medical devices – must obtain a Medical Device Operation Permit.
- Distributors of Class II medical devices – must complete filing with the local authority.
- Online sellers of medical devices – must obtain the appropriate permit/filing and also complete separate online sales filing with the local authority.
- Foreign-invested enterprises (FIEs) – must obtain the same permits as domestic companies.

≡ Application Conditions for Class III Medical Device Operation Permit

To obtain a Class III Medical Device Operation Permit, the applicant must meet the following conditions:

- Qualified personnel – A quality management organization or dedicated quality management personnel commensurate with the business scope and scale. Quality management personnel must hold recognized qualifications (college degree or above in medical device-related fields, or intermediate professional titles).
- Suitable premises – Business premises and storage facilities commensurate with the business scope and scale. Retail Class III operations: at least 60 square meters of business space. Wholesale operations: at least 30 square meters, with at least 15 square meters of warehouse space (requirements vary by region). In vitro diagnostic reagent wholesalers: at least 100 square meters of business space and at least 60 square meters of warehouse space with cold chain facilities.
- Quality management system – Comprehensive quality management system documents aligned with the Medical Device Operation Quality Management Practices (GSP).
- Computer information system – A computer information system that meets GSP requirements and ensures product traceability.
- After-sales service capability – The ability to provide professional guidance, technical training, and after-sales service for the devices being sold.

≡ Required Documents for Class III Medical Device Operation Permit

Medical Device Operation Permit Application Form – Completed application form signed by the legal representative and stamped with the company seal.
Business License – Copy of the company's valid business license (must include medical device operation authorization).
Legal representative and responsible person identification – ID card or passport copies, along with academic degree or professional title certificates of the legal representative, enterprise responsible person, and quality responsible person. Quality responsible persons must have a college degree or higher in a medical device-related field (or an intermediate professional title).
Organizational structure and department setup description – Description of the company's organizational structure and department functions.
Business scope and method description – Detailed description of the intended medical device business scope (products) and operation method (wholesale/retail/both).
Premises and warehouse documents – Location maps and floor plans of the business premises and warehouse, along with property ownership certificates or lease agreements. The premises must not be located in residential housing or other unsuitable locations.
Equipment list – List of business and storage equipment and facilities, including temperature and humidity monitoring equipment, pest control equipment, refrigeration/freezing facilities (if refrigerated products are involved), and cleaning/disinfection equipment.
Quality management system documents – Catalog of quality management system documents, work procedures, and records (including procurement inspection, acceptance, storage, sales, after-sales tracking, adverse event reporting, and recall procedures).
Computer information system description – Description of the computer information system, including its functions for ensuring product traceability and record retention.
Power of attorney – If the application is filed by an agent, a power of attorney and identification of the agent are required.
Product registration certificates and authorization letters – Copies of medical device product registration certificates and manufacturer authorization letters for the devices being sold.

≡ Application Process for Class III Medical Device Operation Permit

Online Application

Submit the application online via the local drug administration's service portal or the NMPA's integrated regulatory platform (approx. 1-2 working days).

Document Review

The authority reviews submitted documents for completeness and compliance (approx. 5-10 working days). If materials are incomplete, the applicant will be notified to make corrections within 5 working days.

On-Site Inspection

Inspectors conduct on-site review of premises, warehouse (temperature control, pest control, refrigeration), computer system traceability, and quality personnel competency. Rectification period (if needed) is not counted toward the review timeline. (Within 20 working days of acceptance)

License Issuance

If approved, the "Medical Device Operation Permit" is issued within 10 working days after the approval decision. The license is valid for 5 years.

≡ Validity Period and Renewal

- Validity period – The Medical Device Operation Permit is valid for 5 years from the date of issuance. The license number, company name, legal representative, business address, business scope, and warehouse address are all recorded in the license.
- Renewal application – Renewal applications should be submitted 30-90 working days before the expiry date to allow sufficient time for processing.
- Conditions for exemption from on-site inspection for renewal – If the company's quality management system, business premises, operation method, business scope, and warehouse conditions have not changed, the renewal application may be exempt from on-site inspection.
- Late renewal – If the license expires, the company must apply for a new license, and all conditions must be re-evaluated. Operations are not permitted during the period without a valid license.

≡ Post-License Compliance Obligations

- Annual self-inspection report – Submit an annual medical device operation quality management self-inspection report to the local drug administration authority by the deadline (typically by March 31 each year).
- Adverse event monitoring – Establish adverse event monitoring procedures and report any adverse events to the monitoring authorities.
- Product recall – Cooperate with manufacturers and authorities in the event of a product recall and maintain recall records.
- Changes requiring notification – Any changes to the legal representative, enterprise responsible person, business address, business scope, or warehouse address must be reported to the licensing authority within the prescribed timeframe. The company must apply for a license amendment before the change takes effect.
- Records retention – Maintain procurement, acceptance, sales, and other records for a period not less than the validity period of the medical device product registration certificate (but at least 5 years).
- Random inspections – Cooperate with unannounced random inspections by the drug administration authority (including monitoring of temperature-controlled products, computer system traceability, and quality management system implementation).

≡ Medical Device Network Sales Compliance

Online sellers of medical devices must obtain the corresponding permit or filing and then complete separate network sales filing with the local drug administration authority. The Medical Device Network Sales Quality Management Practices took effect on 1 October 2025, imposing stricter requirements on online sales activities. Key requirements include:

- Display the medical device operation permit or filing number on the online sales platform.
- Maintain sales records and ensure product traceability through the online platform.
- Cooperate with online monitoring by authorities.

Why Choose FINERISE for Medical Device License Application?

[A]

Expert Regulatory Knowledge

FINERISE stays current with NMPA regulations, GSP requirements, and local practice differences.

[B]

Pre-Assessment Services

We assess your premises, personnel qualification, and management system readiness before official submission.

[C]

End-to-End Support

From document preparation to on-site inspection coordination and license issuance — we manage the entire process.

[D]

Classification Guidance

We help you determine the correct medical device classification for your products and recommend the appropriate application pathway.

Frequently Asked Questions

What is the difference between Class II filing and Class III licensing? +

Class II medical device operations only require filing with the local drug administration authority (submitted online); no on-site inspection is generally required. Class III medical device operations require a full operation permit issued by the municipal drug administration authority, which includes a 20-working-day review period and a mandatory on-site inspection of the premises, warehouse, computer system, and quality personnel. The permit is then valid for 5 years.

Can a foreign-invested company apply for a Medical Device Operation Permit? +

Yes. FIEs and WFOEs with medical device distribution included in their business scope are eligible to apply for the Class III permit or Class II filing. The application requirements are the same as for domestic companies. If medical device distribution is not yet in the business scope, FINERISE can assist with a business license amendment first.

How long does the entire Class III permit application process take? +

The full process typically takes 30-45 working days, including document preparation (7-15 days), document review (5-10 days), on-site inspection (within 20 working days of acceptance), and license issuance (within 10 working days after approval). Some regions have reduced review periods to 20 working days and may offer expedited processing. If premises or systems require rectification, additional time will be needed.

What are the penalties for operating without a Medical Device Operation Permit? +

Operating a Class III medical device business without a valid permit may result in confiscation of illegally obtained income, fines ranging from RMB 50,000 to RMB 150,000 (or higher for severe cases), seizure of medical devices, and potential suspension of business for rectification. In serious cases, criminal liability may arise.

Ready to Start Your Medical Device Business in China?

Contact FINERISE for a free consultation and tailored quotation for your medical device license application.

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