Drugdu.com expert's response:

The handling of medical device business licenses presents certain difficulties, but with systematic preparation and standardized operations, it can be completed successfully. The main challenges lie in complex policies and regulations, stringent technical requirements, cumbersome material preparation, a lengthy approval process, and a scarcity of professional talent. However, enterprises can reduce these difficulties through advance planning, standardized operations, and seeking professional support. The following is a detailed analysis:

Difficulties in Handling

Complex Policies and Regulations: The handling of medical device business licenses involves numerous regulations such as the "Regulations on the Supervision and Administration of Medical Devices" and the "Measures for the Administration of Medical Device Registration." These regulations are complex and frequently updated, requiring enterprises to continuously learn and adapt. Otherwise, they may easily fail in their applications due to non-compliant operations.

Stringent Technical Requirements: During the handling process, sufficient technical materials and proofs must be provided to demonstrate that the products comply with relevant regulations and standards, including aspects such as safety, effectiveness, and stability. This places high demands on an enterprise's product research and development and production capabilities.

Cumbersome Material Preparation: A large amount of materials need to be prepared, including enterprise qualifications, product information, and quality management system documents. Moreover, these materials must be organized according to specific formats and requirements; otherwise, they are likely to be returned or require supplementary submissions.

Lengthy Approval Process: The approval process is relatively cumbersome, involving multiple stages such as acceptance, review, on-site inspection, and approval. Each stage requires a certain amount of time and resource investment, resulting in a long processing period.

Scarcity of Professional Talent: The application process requires the participation of quality management personnel with relevant educational backgrounds or professional titles. However, such talent is relatively scarce in the market, and enterprises may face difficulties in recruitment.

Application Process

Understand Policies, Regulations, and Handling Requirements:

Clearly define the category of medical devices to be operated. Operating Class III medical devices requires a license, operating Class II medical devices requires registration, and operating Class I medical devices does not require a license or registration.

Familiarize yourself with the specific implementation details and relevant policy requirements of the local area, as there may be differences in some details across different regions.

Prepare Application Materials:

Application form for a medical device business license.

Scanned copies or photocopies of the original business license.

Photocopies of the identity documents, educational qualifications, or professional title certificates of the legal representative, enterprise leader, and quality manager.

Description of the enterprise's organizational structure and departmental setup.

Description of the scope and mode of medical device operations.

Geographical location maps and floor plans of the operating premises and warehouse, as well as photocopies of property ownership documents or lease agreements.

List of main operating facilities and equipment.

List of quality management system documents and work procedures for operations.

For enterprises engaged in the operation of Class III medical devices, an introduction to the basic situation and functions of a computer information management system that meets the requirements for quality management in medical device operations is also required.

Authorization document for the handler (if applicable).

Statement guaranteeing the authenticity of the materials.

Submit the Application:

Submit the prepared application materials to the municipal department responsible for drug supervision and administration in the locality where the enterprise is located.

Ensure that the submitted materials are legal, authentic, accurate, complete, and traceable.

On-Site Inspection and Material Review:

After accepting the application for a business license, the municipal department responsible for drug supervision and administration will review the application materials and, if necessary, conduct an on-site inspection in accordance with the requirements for quality management in medical device operations.

Enterprises should actively cooperate with the review and on-site inspection work and promptly rectify any issues identified during the inspection.

Issuance of the License:

If the enterprise meets the specified conditions, a written decision to grant permission will be made, and a medical device business license will be issued within 10 working days.

If the enterprise does not meet the specified conditions, permission will not be granted, and a written explanation will be provided.