Drugdu.com expert's response:

Key Point: Only Class III medical devices require a Medical Device Business License. Class I needs no license, Class II only requires filing. Here is the complete process:

Step 1: Confirm which class you need

Class I (low risk): No license needed, e.g., surgical scalpels, gauze, stethoscopes

Class II (medium risk): Business filing only, e.g., thermometers, blood pressure monitors, nebulizers

Class III (high risk): License required, e.g., cardiac stents, contact lenses, syringes, CT scanners

Note: Starting April 2026, new regulations: individual businesses can no longer apply for Class II or Class III licenses/filings. Applications must be made under a corporate entity (except for individual businesses dealing with 13 specific low-risk Class II products).

Step 2: Corporate qualification preparation

Register a company. The business scope of the business license must include "Class III medical device distribution."

Statutory processing time: 45 working days; in practice, most regions take 15–20 working days.

Step 3: Submit application materials (approximately 9–10 items)

Online (local government service portal / drug administration platform) or in-person at the service window.

Core materials include:

Application form for medical device business license issuance (signed and stamped by legal representative)

Copy of business license

Identity documents + education/professional title certificates of legal representative and quality manager

Description of organizational structure and department setup

Description of business scope and business mode

Location map and floor plan of business premises and warehouse + property certificate / lease agreement

Equipment and facility list (including cold chain equipment, if applicable)

Quality management system and work procedure documents

Description of computer information management system functions (required for Class III)

Authorization letter for the agent

Step 4: Acceptance review

The drug administration department decides whether to accept within 5 working days.

Complete materials → Acceptance notice issued

Incomplete materials → One-time notification for correction (must be completed within 5 days)

Step 5: On-site inspection ⭐ (the most critical step)

After acceptance, the drug administration sends 2 or more inspectors to the site.

Key checks: personnel qualifications, site conditions, equipment configuration, information system functionality, warehouse zoning.

Rectification time is not counted in the approval timeline.

If inspection fails → rectify and re-apply.

Step 6: Approval and license issuance

License is issued within 20 working days after approval.

Valid for 5 years. Apply for renewal 6 months before expiration.

Three mandatory checkpoints:

Personnel: Quality manager must hold a college degree or above in a medical device-related field, or a mid-level or above professional title, with at least 3 years of experience. Additional specialized personnel are required for implantable devices / IVD reagents.

Premises: Business premises ≥ 30–40㎡, warehouse ≥ 15㎡; cold chain products require an independent cold storage; residential addresses are not allowed.

System: A GSP-compliant computer information management system must be in place, enabling full traceability from procurement → acceptance → sales.

Timeline and cost:

Total duration: 20–30 working days under favorable conditions (including on-site inspection). It is recommended to start preparation 3 months in advance.

Official fee: Free

Agency fee: approximately 3,000–8,000 RMB (if needed)

Operating without a license carries a minimum fine of 50,000 RMB