Application for Matters of Records of Starting Business of Class I & Household C

[2008-12-23 16:54:10]

Processing Authority: food and drug sub-administration at district/county level

Processing Procedures:

(I) Any and all of enterprises intending to start business operation of Class I medical appliances shall apply for record to the competent local food and drug sub-administration which governs the place where the enterprises run business operation, and fill in and present the required Letter of Commitment and relevant materials as follows:

1 the Letter of Commitment of Information of Record of Medical Appliance Operation Enterprise;

2 the Notice of Pre-Approval of Business Name issued by the competent industrial and commercial administration;

3 the (xerox copy of the) personal identity card of the legal representative of the very enterprise; and

4 the (xerox copies of the) supporting documents of training of key executive officers of the enterprises (stamped with the official seal);

5 the relevant supporting documents of business (/storage) places: the (xerox copies of the) muniment of title, or the muniment of title of the lessor and the lease agreement;

6 the self-check table of qualification verification conditions for the medical appliance operation enterprise

7 the letter of commitment for liability issued by the parent companies of the enterprises that are one of branches whereof, if any; and

8 other supporting documents necessary for such application.

(II) Any and all of enterprises intending to start business operation of household common medical appliances shall apply for record to the competent local food and drug sub-administration which governs the place where the enterprises run business operation, and fill in and present the required Letter of Commitment and relevant materials as follows:

1 the Letter of Commitment of Information of Record of Medical Appliance Operation Enterprise;

2 the Business License or the Notice of Pre-Approval of Business Name (stamped with the official seal);

3 the (xerox copy of the) personal identity card of the legal representative of the very enterprise;

4 the (xerox copies of the) supporting documents of training of key executive officers of the enterprises (stamped with the official seal);

5 the (xerox copies of the) supporting documents of training of counter sales personnel (stamped with the official seal);

6 the location drawing of medical appliances counters/shelves in the emporium (stamped with the official seal); and

7 other supporting documents necessary for such application.

(III) Any and all of enterprises intending to concurrently sell contraceptive devices or tools as their shall apply for record to the competent local food and drug sub-administration which governs the place where the enterprises run business operation, and fill in and present the required Letter of Commitment.

(IV) Any and all of chain supermarkets or convenient stores intending to concurrently sell the Class I household common medical appliances or contraceptive devices or tools shall apply for record to the competent local food and drug sub-administration which governs the place where the enterprises run business operation, and fill in and present the required Letter of Commitment.

Procedures of Record:

The competent local food and drug sub-administration at district/county level shall, within 5 working days upon receipt of the required Letter of Commitment and other materials presented by the applicants, review and issue the Notice of Record of Household Common Medical Appliance Retail Operation Enterprise in Shanghai, upon which the very applicants may apply to the competent industrial and commercial administration for addition of "medical appliances" into their business scopes.

Charging Standard & Basis: free of charges for any record subject to commitment of information.

Processing Basis:

(I) Regulations of Supervision and Administration of Medical Appliances under No. 276 Order of State Council;

(II) Measures for Supervision and Administration of Medical Appliance Operation Enterprises under No. 19 Order of State Food and Drug Administration;

(III) the classified catalogue of products of China's medical appliances;

(IV) Interim Rules of Shanghai Municipality for Business Start and License of Medical Appliance Operation Enterprises under Hu Yao Jian (2002) No. 650;

(V) Rules of Shanghai Municipality for Record of Regular Commercial Enterprises Starting Businesses of Retail Operation of Household Common Medical Appliances (for Trial Implementation) under Hu Yao Jian Liu Tong (2002) No. 402;

(VI) Notice of Implementation of Commitment of Information and Record Management of Retailing Contraceptive Devices and Tools in Shanghai under Hu Yao Jian Liu Tong (2003) No. 157;

(VII) Notice of Supplementary Regulations on Commitment of Information and Record Management of Household Common Medical Appliances Concurrently Sold by Chain Supermarkets and Convenient Stores in Shanghai under Hu Yao Jian Liu Tong (2004) No. 001; and

(VIII) other applied regulations, rules, and normative documents.

Processing Time: Tuesdays or Thursdays: 9:00~11:00 and 13:00~16:00

Qualified Application Subject:

Scope of Application:

Application for record of enterprises intending to start business operation of Class I and/or household common medical appliances and to concurrently sell contraceptive devices and tools.

Prerequisites for Starting Business:

Any and all of applicants:

(I) that have the required places and environment of business operation;

(II) that have the required quality inspection personnel;

(III) that have the capacities of training, maintenance and other after-sale services of products

(IV) that have established the quality management system of medical appliances; and

(V) that have collected and kept the national standards and the industrial standards related to medical appliances.

Source: 上海市人民政府

Keywords:Quality Supervision

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