Application for License for Business Start of Medical Appliance Production Enter

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

Processing Authority: Safety Control Office under Shanghai Food and Drug Administration

Processing Procedures:

1. Application for Business Start

(1) Any and all of applicants shall represent the application in writing covering any and all of contents as follows:

a. the Application Form for Medical Appliance Production Enterprise in Shanghai;

b. the (xerox copy of the) Notice of Pre-Approval of Business Name issued by the competent industrial and commercial administration;

c. the (originals which will be returned upon review and xerox copies of the) supporting documents for personal identities of the legal representative, partners or investors of the proposed enterprise;

d. the (original which will be returned upon review and xerox copy of the) supporting document of production site (muniment of title or the agreement of lease intent);

e. the (original which will be returned upon review and xerox copy of the) relevant contract or agreement of investment cooperation, and articles of association whereof, if necessary.

(2) Shanghai Food and Drug Administration shall, within 15 working days upon receipt of the complete materials necessary for such application, conduct the due review of them, determine the business type of the very enterprise, make the decision of approving the business start whereof or not, and, in case of approval, issue the Notice of Approving Business Start of Medical Appliance Production Enterprise, or, in case of not-approval, inform the very applicant in writing with causes. The very applicant shall not apply to the competent industrial and commercial administration for business license unless obtains the Notice of Approving Business Start of Medical Appliance Production Enterprise.

2. Application for License of Medical Appliance Production Enterprise

1) Any and all of applicants shall, upon obtaining the business license issued by the competent industrial and commercial administration and completing incorporation preparation of the proposed enterprise, apply to Shanghai Food and Drug Administration for the License of Medical Appliance Production Enterprise or Form for Record Filing of Medical Appliance Production Enterprise, and present any and all of materials as follows (one for each):

a. the Application Form for License (Record Filing) of Medical Appliance Production Enterprise in Shanghai;

b. the (xerox copy stamped with the official seal of the very enterprise of the) Business License issued by the competent industrial and commercial administration;

c. the (xerox copy of the) Notice of Approving Business Start of Medical Appliance Production Enterprise,

d. the (original which will be returned upon review and xerox copy of the) supporting document of production site [muniment of title or the agreement of lease intent (muniment of title of the lessor presented by the lessee, if any)];

e. the standard for registered products of Class I/II products reviewed by Shanghai Food and Drug Administration or of Class III products upon first review;

f. the (xerox copies of the) supporting documents for qualifications and trainings of the relevant personnel;

g. the running experimental verification summary and test record of production/checkout equipments (the statutory supporting documents shall be presented in case of products with special requirements);

h. the (xerox copy of the) checkout report of production environment of aseptic medical appliance products, if applicable; and

i. the quality assurance system file or the list of quality management system directory.

2) Shanghai Food and Drug Administration shall, within 30 working days upon receipt of application for license/record filing by the very medical appliance operation enterprises, review them subject to the applicable provisions, conduct the field survey to lead two kinds of outcomes of field survey: "passing field review" in case of Class A or B in the overall score, or "not passing field review" in case of Class C in the overall score, issue the License of Medical Appliance Production Enterprise to Class II/III medical appliance operation enterprise that pas passed the materials review and field review, or the Form of Record Filing of Medical Appliance Production Enterprise to Class I medical appliance operation enterprise, and issue the notice of review termination with causes to the enterprise whose production conditions fail to meet the provided conditions.

3. Application for Change of License

(1) The medical appliance operation enterprises may, upon completion of product registration, apply to Shanghai Food and Drug Administration for changing the License of Medical Appliance Production Enterprise valid only for application for product registration into the License of Medical Appliance Production Enterprise with the normal valid term, and resent any and all of materials as follows (one for each):

a. the Application Form for Changing License of Medical Appliance Production Enterprise in Shanghai;

b. the (xerox copy of the) the relevant supporting documents for changing license and the certificate of product registration;

c. the original and copy of the License of Medical Appliance Production Enterprise;

(2) Shanghai Food and Drug Administration shall, within 20 working days upon receipt of the complete materials necessary for changing license, conduct the due review of them and make the decision of approving to change license by issuing the License of Medical Appliance Production Enterprise with normal valid period to the very applicant, or not approving to change license by inform the very applicant in writing with causes.

Charging Standard and Basis: 1. RMB 600 per License of Medical Appliance Production Enterprise (producing Class II/III products).

2. RMB 300 per Form of Record Filing of Medical Appliance Production Enterprise (producing Class I products)

Processing Address: Shanghai Drug and Medical Appliance Review and Assessment Center, No. 1399, Huashan Road, Shanghai

Processing Basis:

1. Articles XIX and XX of Regulations on Supervision and Administration of Medical Appliances under No. 276 Order of State Council;

2. Measures for Supervision and Administration of Medical Appliance Production Enterprises under No. 18 Order of State Food and Drug Administration;

3. Notice on Printing and Forwarding Detailed Rules for Implementation of License and Record Filing of Medical Appliance Production Enterprises in Shanghai under Hu Yao Jian (2002) No. 349 issued by Shanghai Food and Drug Administration; and

4. 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.

Contact Tel: 021-62837766- 811、812、813

Processing Time: Mondays through Thursdays: 9:00~11:30 and 13:00~16:30

Fridays: 9:00~11:30

Time Limit for Processing:

Qualified Application Subject: Scope of Application:

Any and all of Class I medical appliance production enterprises intending to start businesses in Shanghai apply for the Forms of Record Filing of Medical Appliance Production Enterprise; and Any and all of Class II/III medical appliance production enterprises intending to start businesses in Shanghai apply for the Licenses of Medical Appliance Production Enterprise.

Qualifications/Prerequisites for Applicant:

(1) There are professional technical personnel corresponding to the medical appliances produced whereby;

(2) There are production/storage place and environment corresponding to the medical appliances produced whereby;

(3) There are production equipments corresponding to the medical appliances produced whereby;

(4) There are inspection institutions or personnel, and inspection equipments for inspection of medical appliances produced whereby; and

(5) There are production quality assurance system or quality management system.

Source: 上海市人民政府

Keywords:Quality Supervision

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