Drugdu.com expert's response:

 

The process of obtaining medical device qualifications involves multiple stages and stringent requirements, necessitating the preparation of corresponding materials and adherence to legal procedures based on the classification of medical devices (Class I, Class II, Class III) and the specific type of business operation (manufacturing or distribution). Below is a detailed explanation:

I. Clarifying the Type of Qualification to Be Obtained

Medical device qualifications are primarily categorized into manufacturing qualifications and distribution qualifications. These are further classified into Class I, Class II, and Class III based on the risk level of the medical devices. The requirements and procedures for obtaining qualifications vary across different categories.

Class I Medical Devices: These pose a low risk and are subject to routine management. Generally, they only require filing and do not necessitate a license.

Class II Medical Devices: These carry a moderate risk and require strict control and management. Distribution enterprises must obtain a Class II Medical Device Distribution Filing Certificate.

Class III Medical Devices: These present a higher risk and necessitate special measures for stringent control and management. Distribution enterprises must obtain a Medical Device Distribution License, while manufacturing enterprises must obtain both a Medical Device Manufacturing License and a Medical Device Registration Certificate.

II. Process and Requirements for Obtaining Medical Device Distribution Qualifications (Taking Class II and Class III as Examples)

(1) Eligibility Criteria

Enterprise Qualifications

Possess a quality management organization or quality management personnel commensurate with the scope and scale of business operations. Quality management personnel should hold a nationally recognized relevant professional qualification or title. For instance, when distributing Class III medical devices, quality management personnel should possess a college degree or above in a medical device-related major or an intermediate professional technical title or above.

Have operating and storage premises suitable for the scope and scale of business operations. These premises should be clean, hygienic, and meet the storage requirements for the products.

Implement a quality management system appropriate for the medical devices being distributed.

Possess the capability to provide professional guidance, technical training, and after-sales services for the medical devices being distributed, or have an agreement with a relevant institution to provide technical support.

Premises Requirements

Operating premises and warehouses must not be located within residential buildings, military management zones (excluding leasable areas), or other inappropriate locations for business operations.

The area of operating premises and warehouses should meet business requirements. For example, when distributing Class III medical devices, the operating premises area should generally be no less than 100 square meters, and the warehouse area should generally be no less than 60 square meters (specific area requirements may vary by region).

(2) Application Materials

Class II Medical Device Distribution Filing Certificate

"Class II Medical Device Distribution Filing Form".

A copy of the enterprise's business license.

Copies of the identity, educational background, and professional title certificates of the enterprise's legal representative or person in charge, as well as the quality manager.

A description of the enterprise's organizational structure and departmental setup.

A description of the scope and mode of business operations.

A geographical location map, floor plan, and copies of the property ownership certificate or lease agreement (with the property ownership certificate attached) for the operating premises and warehouse address.

A list of operating facilities and equipment.

A list of documents such as the operating quality management system and work procedures.

An authorization certificate for the handler.

Medical Device Distribution License

In addition to the materials required for the Class II Medical Device Distribution Filing, the following materials are also needed:

An introduction and functional description of the basic situation of the computer information management system (meeting the requirements of medical device distribution quality management).

Copies of the registration certificates for the products intended for distribution and a product catalog (applicable to enterprises distributing specific products).

Other materials with special requirements, such as a cold chain facility and equipment validation report for enterprises distributing in vitro diagnostic reagents.

(3) Application Process

Online Application: Log in to the online service platform of the local drug regulatory authority, fill in the application information, and upload the relevant materials.

Submission of Paper Materials: Submit the printed application form and other paper materials that have passed the online application review to the local drug regulatory authority.

Material Review: The drug regulatory authority reviews the application materials. If the materials are complete and in compliance with the statutory form, they will be accepted; if the materials are incomplete or do not comply with the statutory form, the applicant will be informed of all the necessary corrections on the spot or within 5 working days.

On-Site Inspection: Within 30 working days from the date of acceptance, the drug regulatory authority will review the application materials and conduct an on-site inspection in accordance with the requirements of the medical device distribution quality management standard.

Approval and Issuance of License: For qualified applicants, a written decision approving the license will be made, and the "Medical Device Distribution License" will be issued within 10 working days. For unqualified applicants, a written decision denying the license will be made, along with an explanation of the reasons.

III. Process and Requirements for Obtaining Medical Device Manufacturing Qualifications

(1) Eligibility Criteria

Personnel Requirements

The enterprise's person in charge should possess a college degree or above in a medical device-related major or an intermediate professional technical title or above and be familiar with the laws, regulations, and rules governing medical device manufacturing.

The production, quality, and technical managers should possess professional knowledge appropriate for the products being manufactured and have at least 3 years of work experience in a relevant industry.

Personnel engaged in work affecting product quality should undergo training appropriate for their job requirements and possess relevant theoretical knowledge and practical operational skills.

Premises and Facilities Requirements

Have production premises, environmental conditions, production equipment, and professional technical personnel suitable for the medical devices being manufactured.

Have a quality inspection organization or full-time inspection personnel and inspection equipment for the medical devices being manufactured.

System Requirements

Implement a quality management system to ensure the quality of medical devices, including systems for procurement, incoming goods inspection, warehousing and storage, outbound recheck, quality tracking, and adverse event reporting.

(2) Application Materials

"Application Form for Medical Device Manufacturing License".

A copy of the business license.

Copies of the registration certificates and product technical requirements for the medical devices being manufactured held by the applicant enterprise.

Copies of the identity certificates of the legal representative and the enterprise's person in charge.

Copies of the identity, educational background, and professional title certificates of the production, quality, and technical managers.

A list of the educational backgrounds and professional titles of personnel in production management and quality inspection positions.

Proof documents for the production premises, including copies of property ownership certificates or lease agreements and the property ownership certificates of the lessor, a general layout plan of the factory area, and a layout plan of the main production workshops. For workshops with cleanliness requirements, the functional rooms and the flow of personnel and materials must be indicated.

A list of the main production equipment and inspection equipment.

A quality manual and procedural documents.

A process flow chart.

An authorization certificate for the handler.

(3) Application Process

Application: The enterprise submits an application and relevant materials to the food and drug regulatory authority of the province, autonomous region, or municipality directly under the Central Government where it is located.

Acceptance: Upon receiving the application, the food and drug regulatory authority conducts a formal review of the application materials. If the materials meet the requirements, the application will be accepted.

On-Site Inspection: The food and drug regulatory authority organizes an on-site inspection of the applicant enterprise's production conditions and quality management system.

Approval and Issuance of License: For enterprises that meet the regulations upon review, a written decision approving the license will be made, and the "Medical Device Manufacturing License" will be issued within 10 working days. For enterprises that do not meet the regulations, a written decision denying the license will be made, along with an explanation of the reasons.

By editor