Application for Business Starting License and Registration Alteration of Classes

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

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

Processing Procedures:

(I) Business Starting Procedures

1 Any and all of Classes II & III medical appliance operation enterprises shall, upon business starting, apply to the competent local food and drug sub-administration that governing the place where the enterprises run business operation and present any and all of the following materials whereto:

(1) the Notice and Letter of Commitment of Business Starting License 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) other supporting documents necessary for such application.

2 The competent food and drug sub-administration at district/county level shall, within 5 working days upon receipt of the said Letter of Commitment and other relevant materials presented by the very applicant, duly review them and issue the Notice of Business Starting License of Medical Appliance Operation Enterprise to the very applicant which shall, upon presenting such Notice, apply to the competent industrial and commercial administration for the Business License.

Any and all of enterprises whose applied business scope is "all kinds of medical appliances" shall apply to the municipal food and drug administration.

(II) Licensing Procedures

1 Any and all of enterprises shall, upon completing incorporation preparation subject to the Interim Rules of Shanghai Municipality for Business Start and License of Medical Appliance Operation Enterprises, apply to the competent local food and drug sub-administration that governs the place where the enterprises run operation and present any and all of the following materials whereto:

(1) the Application Form for License of Medical Appliance Operation Enterprise;

(2) the (xerox copy of the) Business License (stamped with the official seal);

(3) the (xerox copies of the) supporting documents of qualification and training of key executive officers of the enterprises;

(4) 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;

(5) the self-check table of qualification verification conditions for the medical appliance operation enterprise;

(6) the catalogue of the business operation quality management system of the enterprises;

(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.

2 The competent food and drug sub-administration at district/county level shall, within 15 working days upon receipt of the materials necessary for such application, conduct the due review of them and of the field, and issue the License of Medical Appliance Operation Enterprise to the very applicant which is qualified for the said conditions or inform the very applicant who failed in meeting the said conditions of causes for not-approval in writing, if any.

Any and all of enterprises whose applied business scope is "all kinds of medical appliances" shall be subject to the joint review and approval by the municipal food and drug administration and the competent local food and drug sub-administration which governs the place where the enterprises run business operation, and to the routine supervision and administration by that sub-administration.

(III) Application for Alteration

1 Any and all of enterprises who intend to alter the License of Medical Appliance Operation Enterprise in part or in whole shall apply to the competent local food and drug sub-administration that governs the place where the enterprises run business operation and present any and all of the following materials whereto:

(1) the Application Form for Alteration of Medical Appliance Operation Enterprise;

(2) the original and copy of the License of Medical Appliance Operation Enterprise;

(3) the (xerox copy of the) Business License;

(4) supporting documents related to such alteration are as follows:

In case of alteration of the legal representative or the key officer of the enterprise, the official document of approval by the enterprise's governing authority and/or the resolution by the board of directors whereof, and the (xerox copy of the) personal identity card and training certification of the substitute legal representative or the key officer of the enterprise shall be presented.

In case of alteration of the business name, the xerox copy of the Notice of Pre-Approval of Business Name issued by the competent industrial and commercial administration shall be presented.

In case of alteration of the place of business operation, the house lease agreement and/or the muniment of title shall be presented.

In case of alteration of the business scope, the (xerox copies) of the supporting documents for qualification and training of the key executive officers of the very enterprise, the self-check table of qualification verification conditions for the medical appliance operation enterprise, and the catalogue of the business operation quality management system of the enterprise shall be presented.

(5) other supporting documents necessary for such application

2 The competent food and drug sub-administration at district/county level shall, within 5 working days upon receipt of the materials necessary for application for alteration of the legal representative, the key officer, or the business name of the very enterprise, make the decision of approval or not, and shall, within 10 working days upon receipt of the materials necessary for application for alteration of the place of business operation or the business scope, conduct the due field review and make the decision of approval or not.

Any and all of enterprises who apply for alteration of the business scope into "all kinds of medical appliances" shall be subject to the joint review and approval by the municipal food and drug administration and the competent local food and drug sub-administration which governs the place where the enterprises run business operation, and to the routine supervision and administration by that sub-administration.

Charging Standard & Basis: RMB 300 per License of Medical Appliance Operation Enterprise

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) Regulations of Shanghai Municipality on Supervision and Administration of Disposable Aseptic Medical Appliances under No. 5 Order of Shanghai Municipal People's Government;

(V) Measures for Supervision and Administration of Disposable Aseptic Medical Appliances under No. 24 Order of State Food and Drug Administration;

(VI) Detailed Rules for Implementation of Qualification Approval of Enterprises Running Business Operation of Disposable Aseptic Medical Appliances (for Trial Implementation) under Guo Yao Jian Shi (2001) No. 444;

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

(VIII) Rules of Shanghai Municipality for Application for Alteration of Licenses of Medical Appliance Operation Enterprises under Hu Yao Jian (2002) No. 883; and

(IX) Reply on Approval of Imposing Charges for Review of Licenses of Medical Appliance Production/Operation Enterprises under Hu Cai Zong (2000) No. 46 and Hu Jia Xing (2000) No. 158 jointly issued by Shanghai Finance Bureau and Shanghai Pricing Bureau.

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

Qualified Application Subject: 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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