Drugdu.com expert's response:

 

Class III Medical Device Production License → Apply to the Provincial Drug Administration

Class III Medical Device Operation License → Apply to the Municipal Drug Administration

Both require compliant premises, qualified personnel, a quality management system, and a traceability system. Statutory approval period: 20 working days. Validity: 5 years.

I. Production License (Provincial Drug Administration)

1. Application Requirements

Corporate Qualification: Legal corporate entity; business scope must cover the corresponding production category.

Premises & Environment: Production facilities and cleanroom environment must match the product standards.

Personnel: Production, Quality, and Technical Directors must hold a relevant major, a college degree or above, and at least 3 years of experience. Inspection personnel and equipment must be fully staffed.

Equipment & Documentation: Production and inspection equipment must be complete. Quality manual, procedure documents, and process flowcharts must be fully prepared.

Product Registration: The Medical Device Registration Certificate must already be obtained.

2. Required Materials

Medical Device Production License Application Form

Copy of Business License

Copy of Medical Device Registration Certificate and Product Technical Requirements

ID, degree, and professional title certificates of the Legal Representative, Production Director, Quality Director, and Technical Director

Proof of production premises (property ownership or lease); environmental test report (if required)

List of major production and inspection equipment

Quality manual, procedure documents, and process flowcharts

After-sales service capability documentation

Authorization letter for the agent handling the application

3. Process

Step 1 – Preparation: Organize all materials according to the checklist, affix official stamps, and scan for archiving.

Step 2 – Submission: Submit online via the provincial government portal or NMPA system, or in person at the service window.

Step 3 – Formal Review (5 working days): The authority checks for completeness. If materials are insufficient, they will issue a one-time notice for correction. If compliant, an acceptance notice is issued.

Step 4 – On-site Inspection (Critical): A GMP-based inspection verifies the premises, equipment, personnel, documentation, and records. This may be merged with the registration system inspection.

Step 5 – Approval Decision (20 working days): If compliant, the license is issued. If not, a written explanation is provided.

Step 6 – License Collection & Publication: Collect the license at the window or by mail. It is also published on the official website. Valid for 5 years.

II. Operation License (Municipal Drug Administration)

1. Application Requirements

Corporate Qualification: Corporate entity; business scope must include "Class III Medical Device Operation."

Premises:

Business premises: At least 40㎡ (commercial or industrial use, not residential).

Warehouse: At least 30㎡; for sterile or implantable devices, at least 200㎡. Must be zoned (quarantine, approved, rejected, return), with temperature and humidity monitoring, and pest and fire prevention.

Personnel:

Quality Director: Relevant major, college degree or above, plus at least 3 years of quality management experience. Must not hold any concurrent roles.

Quality Management Staff: Relevant major or professional title. For implantable or in-vitro diagnostic products, dedicated after-sales personnel are required.

System & Traceability: A complete GSP quality management system is required. A computerized traceability system must cover the full chain of procurement, sales, inventory, cold chain temperature, and auditable records.

2. Required Materials

Medical Device Operation License Application Form

Copy of Business License

ID, degree or professional title certificates, and resume of the Legal Representative and Quality Director

Business premises and warehouse: location map, floor plan (with area and zone annotations), property ownership or lease agreement

List of major operation and storage facilities and equipment (including temperature and humidity monitoring and cold chain equipment)

GSP quality management system catalog (covering procurement, acceptance, storage, maintenance, sales, non-conforming products, traceability, etc.)

Computer information management system description (functions, modules, security, backup)

Authorization letter for the agent handling the application

3. Process

Step 1 – Preparation: Organize and stamp all materials, scan them, and ensure the computer system is fully operational.

Step 2 – Submission: Submit online via the municipal government portal or NMPA platform, or in person at the service window.

Step 3 – Formal Review (5 working days): Check for completeness. Issue an acceptance notice or request supplementary materials.

Step 4 – On-site Inspection (Mandatory): Verify premises area and zoning, equipment operation, personnel on-site, system execution, and traceability demonstration. For cold chain products, a live temperature control demonstration is required.

Step 5 – Approval Decision (20 working days): Issue the license if compliant; provide a written explanation if rejected.

Step 6 – License Collection & Publication: Collect at the window or by mail. Published on the official website. Valid for 5 years. Apply for renewal 6 months before expiry.

III. Common Rejection Reasons & How to Avoid Them

Non-compliant premises: Using a residential address, insufficient area, shared warehouse, or missing functional zones.

Insufficient personnel qualifications: The Quality Director's major does not match the requirements, insufficient experience, or holding concurrent roles.

Incomplete documentation system: GSP system is incomplete, records are blank, or there is no traceability process.

Non-functional traceability system: The computer system lacks purchase-sales-inventory or temperature records and cannot demonstrate operation.

False or inconsistent materials: Contradictions in address, personnel, or equipment information across documents.

IV. Key Reminders

Production is not the same as Operation. The production license is issued by the provincial authority; the operation license is issued by the municipal authority. They must be applied for separately.

Registration Certificate comes first. Production enterprises must obtain the product registration certificate before applying for the production license.

Traceability system is mandatory for Class III operation. It must cover the entire chain from procurement to after-sales.

Self-check before submission. Verify every item against GSP or GMP standards before submitting. If necessary, hire a third party to conduct a pre-audit.

By editor