Drugdu.com expert's response:

I. Application Requirements

1. Basic Requirements

Possess production facilities, environmental conditions, manufacturing equipment, and qualified technical personnel suitable for the medical devices to be produced.

Establish a quality inspection department staffed with full-time inspectors and equipped with necessary testing instruments.

Develop and implement a quality management system covering production, quality control, and technical documentation to ensure medical device quality.

Demonstrate after-sales service capabilities appropriate for the medical devices produced.

2. Personnel Requirements

Production, quality, and technical managers must possess professional expertise relevant to the medical devices produced and be familiar with applicable regulations and technical standards.

The quality manager shall not concurrently serve as the production manager.

The proportion of technical personnel with junior professional titles (or above) or secondary vocational education (or higher) within the enterprise must meet product-specific requirements.

For Class III medical device manufacturers, at least two internal auditors compliant with quality management system requirements and at least two full-time technical personnel with intermediate professional titles (or above) or college degrees (or higher) in relevant fields must be employed.

3. Facility and Equipment Requirements

Production facilities must meet product and production scale requirements, with storage areas and environmental conditions complying with standards.

Medical devices with special environmental or equipment requirements (e.g., sterile products) must adhere to national and industry standards, as well as relevant regulations.

II. Application Process

1. Prepare Application Documents

Basic Documents:

Application Form for Medical Device Manufacturing License (including power of attorney, copy of the authorized representative’s ID, and a declaration of authenticity for all submitted materials).

Copy of the enterprise’s business license.

Copies of identification documents and appointment letters for the legal representative and enterprise负责人 (person in charge).

Personnel Qualification Documents:

Copies of identification, educational, and professional title certificates, along with resumes, for production, quality, and technical managers.

A list of personnel in production management and quality inspection roles, including their educational backgrounds and professional titles.

Facility and Equipment Documents:

Proof of production facility ownership (e.g., property certificate or lease agreement), along with a site plan of the factory, a layout of the main production workshop, and a layout of the warehouse.

A list of major production equipment and testing instruments.

For products requiring special production environments, submit copies of facility and environmental compliance certificates.

Technical and Management Documents:

Quality manual and procedural documents.

Process flowcharts for the intended products, highlighting key control points and parameters.

Product technical requirements and their preparatory explanations.

Product risk assessment reports.

Other Documents:

Copies of the medical device registration certificate and product technical requirements (for products already registered).

A self-assessment form for manufacturing compliance (prepared according to provincial regulatory guidelines).

Proof of after-sales service capabilities.

Power of attorney for the applicant’s representative.

2. Submit the Application

Submit all application materials to the provincial, autonomous regional, or municipal drug regulatory authority where the enterprise is located.

3. Review and Evaluation

Formal Review: The regulatory authority checks the completeness and compliance of submitted materials within 5 working days, issuing either a Notice of Material Supplementation or a Notice of Acceptance.

Documentary Review: Verification of technical personnel ratios, equipment-facility compatibility, and other criteria.

On-Site Inspection: The regulatory authority organizes experts to conduct an on-site assessment of production conditions and the quality management system, evaluating compliance with the On-Site Inspection Standards for Medical Device Manufacturing Licenses.

4. Approval and Issuance

The regulatory authority makes an approval decision within 30 working days from the date of acceptance.

If approved, the Medical Device Manufacturing License is issued within 10 working days; if rejected, a written explanation is provided.

III. Key Considerations

Regional Variations: Specific requirements may vary due to local policy adjustments. Applicants are advised to consult the local drug regulatory authority or a professional service agency in advance.

Material Authenticity: Enterprises are responsible for the authenticity of all submitted documents. Providing false certifications will result in severe penalties.

Cooperation During Inspection: Actively cooperate with on-site inspections by regulatory authorities and promptly address any feedback or issues raised.

Renewal and Modifications: The license is valid for 5 years. Renewal applications must be submitted at least 6 months prior to expiration. Changes to production addresses or scope require re-approval or filing, as applicable.