Are there any requirements for Shanghai Class II and Class III medical device enterprises to apply?

The second kind of business archiving

First, the basis for handling

1, Regulations on the Supervision and Administration of Medical Devices (the State Council Decree No.650th 20 14)

2. Measures for the Supervision and Administration of Medical Devices (Order No.8 of State Taxation Administration of The People's Republic of China, 20 14)

3. Quality Management Standard for Medical Devices (Announcement No.58 of the State Administration of Taxation No.2014)

4. Notice of Shanghai US Food and Drug Administration on Implementing Relevant Matters (Shanghai Medical Machinery No.6 [2014] No.738)

5. Notice of Shanghai US Food and Drug Administration on Printing and Distributing (Shanghai Yaoxie No.6 [2015] No.785)

Second, the agency

The food and drug supervision and administration department of the district (county) where the address of the business premises is located.

Third, the examination and approval conditions

(a) there are quality management institutions or quality management personnel suitable for the business scope and scale, and the quality management personnel shall have relevant professional qualifications or titles recognized by the state;

(2) Having a business and storage place suitable for the business scope and scale;

(3) Having storage conditions suitable for the business scope and scale, and entrusting all storage to other medical device business enterprises, there is no need to set up warehouses;

(4) Having a quality management system suitable for the medical devices it deals in;

(5) Having professional guidance, technical training and after-sales service capabilities suitable for the medical devices operated, or agreeing to provide technical support from relevant institutions.

Fourth, the number of approvals.

Verb (abbreviation of verb) application materials

1, newly opened the second type of medical device business enterprise:

(1) List of filing application materials for Class II medical device enterprises;

(two) the second kind of medical device business record form;

(3) A valid business license (the name and domicile of the enterprise are consistent with the business license) and a copy of the organization code certificate (the original should be checked, and the branch should submit the above materials of the head office at the same time);

(4) A copy of the identity certificate, education or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of quality;

(5) Description of organization and department setting: the schematic diagram of organization (key quality management department) and the description of department setting function and personnel composition are required;

(6) Description of business scope and mode: product classification catalogue number, classification name and copy of product registration certificate (official seal of supplier); The mode of operation shall indicate the wholesale/wholesale/retail operation and the description of the mode of operation;

(7) Management of quality management system, working procedures (in vitro diagnostic reagent wholesale enterprises only) and other documents;

(8) Geographical location map, internal layout map (indicating the usable area) of the address of the business place and warehouse, and a copy of the property right certificate or lease agreement (with the property right certificate attached). If subletting, the relevant consent documents of the property owner shall be provided; If the lease agreement is about to expire, it is necessary to provide proof that the property owner agrees to renew the lease;

(9) Catalogue of facilities and equipment in the business premises and warehouses;

(10) agent authorization certificate (according to the template);

(1 1) The applicant provides the commitment materials for the authenticity of the above documents, and the legal person signs and affixes the original official seal (according to the template);

(12) Other special requirements certification materials:

There are more than 2 (including 2) professionals engaged in the inspection of diagnostic reagents.

Time limit for examination and approval of intransitive verbs

The materials are complete and filed on the spot.

VII. Approval Documents

Eight. Rights and obligations of the applicant

Nine, apply for acceptance

The food and drug supervision and administration department of the district (county) where the address of the business premises is located.

X. Consultation channels

1233 1,23 1 1 1 1 1 1

XI。 Complaint channel

1233 1

Twelve. processing method

General procedure

Thirteen. Decided to make it public

Fourteen Schematic diagram of workflow

Fifteen. Other information

The third kind of business license

First, the basis for handling

1, Regulations on the Supervision and Administration of Medical Devices (the State Council Decree No.650th 20 14)

2. Measures for the Supervision and Administration of Medical Devices (Order No.8 of State Taxation Administration of The People's Republic of China, 20 14)

3. Quality Management Standard for Medical Devices (Announcement No.58 of the State Administration of Taxation No.2014)

4. Notice of Shanghai US Food and Drug Administration on Implementing Relevant Matters (Shanghai Medical Machinery No.6 [2014] No.738)

5. Notice of Shanghai US Food and Drug Administration on Printing and Distributing (Shanghai Yaoxie No.6 [2015] No.785)

Second, the agency

Shanghai US Food and Drug Administration

Third, the examination and approval conditions

(2) Having a business and storage place suitable for the business scope and scale;

(3) Having storage conditions suitable for the business scope and scale, and entrusting all storage to other medical device business enterprises, there is no need to set up warehouses;

(4) Having a quality management system suitable for the medical devices it deals in;

(6) An enterprise engaged in the operation of Class III medical devices shall also have a computer information management system that meets the quality management requirements of medical device operation, so as to ensure the traceability of the products it operates.

(seven) enterprises engaged in providing warehousing and distribution services for other production and operation enterprises shall have freight vehicles and related facilities and equipment suitable for the scale of logistics business, and meet the requirements of the temperature and other characteristics of medical devices.

Fourth, the number of approvals.

Verb (abbreviation of verb) application materials

1) List of application materials for Shanghai Medical Device Business License;

(2) Application Form for Shanghai Medical Device Business License;

(4) A copy of the identity certificate, education or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of quality;

(7) Management of quality management system, working procedures (in vitro diagnostic reagent wholesale enterprises only) and other documents;

(nine) the list of facilities and equipment at the address of the business place and warehouse;

(10) Basic introduction and functional description of the computer management system (see Article 42 of the Detailed Rules for the Implementation of Quality Management Standards for Medical Devices in Shanghai for requirements);

(1 1) agent authorization certificate (according to the template);

(12) The original official seal signed by the legal person (according to the template) shall be affixed to the commitment materials for the authenticity of the application materials;

(13) Other special requirements certification materials:

Original commitment letter for retail contact lenses;

Identity certificates, photocopies of academic qualifications or titles, and original work experience certificates of two or more professionals engaged in diagnostic reagent testing.

Copy of financial license for financial leasing or approval certificate of foreign-invested enterprise.

(14) Providing warehousing and distribution services for other production and operation enterprises (third party logistics) Relevant application materials in the business application (third party logistics) Providing warehousing and distribution services for other production and operation enterprises (third party logistics).