Medical Device Operation Recording/Operation License

I. Main legal basis

Regulations for the Supervision and Management of Medical Devices

Measures for the Supervision and Management of Medical Device Operation

Good Supply Practice

On-site Inspection Guidelines in Good Supply Practice

II. Classification management

The medical device operation is subject to classification management depending on the risk levels of the medical devices.

The license and recording are not required for the operation of Class I medical devices.

The operation of Class II medical devices is subject to recording management.

The operation of Class III medical devices is subject to license management.

III. Operation recording/operation license

To engage in medical device operation, the following conditions shall be met:

(I) Possess quality management organization or personnel suitable for the scope and scale of operation; the quality management personnel shall have relevant professional degrees or titles recognized by China;

(II) Possess sites for operation and storage, which are suitable for the scope and scale of operation;

(III) Possess storage conditions suitable for the scope and scale of operation, and it is not necessary to set up a warehouse if the medical devices are all entrusted to other medical device operation enterprises for storage;

(IV) Possess quality management system suitable for the medical devices operated;

(V) Possess adequate ability for professional guidance, technical training and after-sales services for the medical devices operated, or appoint a related organization to provide technical support.

The enterprise engaged in the operation of Class III medical devices shall also have a computer information management system that meets the requirements for quality management of medical device operation to ensure that the products it operates can be traced back. The enterprise engaged in the operation of Class I/II medical devices is encouraged to establish a computer information management system that meets the requirements for quality management of medical device operation.

           Example of medical device operation recording certificate

Example of medical device operation license

Application process:

The enterprises engaged in the operation of Class II medical devices shall record with the local municipal food and drug administration departments of the cities with subordinate districts, fill in the Class II medical device operation recording forms, and submit the dossiers.

The enterprises engaged in the operation of Class III medical devices shall file the applications with the local municipal food and drug administration departments of the cities with subordinate districts.

System assessment:

The enterprises engaged in the operation of medical devices shall establish and improve the quality management systems compatible with the medical devices they operate and ensure the effective operation of the systems in accordance with the requirements of the Good Supply Practice in combination with the product characteristics.

The inspection content involved in the GSP quality management system mainly includes the followings:

(I) Responsibilities and systems

(II) Personnel and training

(III) Facilities and equipment

(IV) Purchasing, receipt and acceptance

(V) Warehouse-in, storage and inspection

(VI) Sales, warehouse-out and transportation

(VII) After-sales service

Certificate maintenance and update:

The Class II medical device operation recording certificate is permanently valid.

The validity period of the Class III medical device operation license is 5 years.

Renewal of application:

If the medical device operation license needs to be renewed after the expiration of the validity period, the medical device operation enterprise shall file an application for the renewal of the medical device operation license to the original license-issuing department 6 months before the expiration of the validity period.

Change of application:

Changes of the items in the medical device operation license are classified into changes of licensed items and changes of registered items.

Changes of licensed items include the changes of operation site, operation mode, operation scope, and warehouse address. Changes of registered items refer to the changes of items other than those mentioned above.

In the case of changes of licensed items, an application for the change of the medical device operation license shall be submitted to the original license-issuing department, and the materials related to the changes specified in Article VIII herein shall be submitted.

In the case of changes of registered items, the medical device operation enterprise shall promptly go through the change procedures with the municipal food and drug administration department of the city with subordinate districts.

IV. Declaration documents

The medical device operation recording/license dossiers generally include the followings:

(I) Operation license application form;

(II) Business license;

(III) Copies of the identity certificates, academic qualifications or professional title certificates of the legal representative, the person in charge of the enterprise, and the person in charge of quality;

(IV) Organizational structure and department setting;

(V) Operation scope and mode;

(VI) Copies of the geographical location plans and floor plans of the operation site and warehouse and the property ownership certificate or lease agreement (with the housing property certificate attached);

(VII) Catalogue of the facilities and equipment operated;

(VIII) Catalogue of the documents such as operation quality management system and working procedures;

(IX) Basic information and functional description of the computer information management system; (operation license for Class III medical devices);

(X) Self-inspection report of the operation quality management system;

(XI) Letter of authorization for the handler;

(XII) Other certification materials.

V. Service content

SUNGO can provide services related to the Chinese regulations, including:

·  Develop the application solutions

·  Make the medical device classification definition declaration

·  Assist the enterprise to establish the GMP or GSP management system

·  Prepare the medical device recording/registration dossiers

·  Assist the enterprise to obtain the product recording/production recording certificates

·  Assist the enterprise to obtain the product registration certificate/production license/operation license

·  Assist in obtaining the product recording/registration certificates of imported medical devices

·  Provide the training and counseling on medical device regulations

·  Renewal of registration/change of licensed items/change of registered items

·  Production license renewal/production license change

VI. Service process