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Processing Authority: Safety Control Office under Shanghai Food and Drug
Administration
Processing Procedures:
1. Application
(1) Any and all of
applicants shall, subject to requirements in the Measures for Quality System
Assessment by Medical Appliance Production Enterprises and with reference to the
standards of GB/T19001 and YY/T0287 (or B/T19002 and YY/TO288), establish the
quality assurance system and procure the system to run effectively. Prior to
application for the said, assessment, the very applicant shall, subject to the
Self-check Form for Enterprise of Quality System Assessment, conduct a careful
self-check, fill in the self-check form and summary, and present any and all of
materials as follows:
a) the letter of application for quality system
assessment of medical appliance production enterprise attached with the
self-check form for enterprise of quality system assessment (in duplicate in
case of Class II products, or in triplicate in case of Class III
products);
b) one self-check summary;
c) one quality assurance system
file and one list of quality management system directory; and
d) one reviewed
standard for registered products.
(2) Any and all of enterprises applying for
exempting from field assessment subject to Article II of the Measures for
Quality System Assessment by Medical Appliance Production Enterprises shall,
besides the above materials, present the application in writing covering the
contents of the quality system status of the very product qualified for
application for registration of production permit, the cause(s) for exempting
from field assessment, and the statement of maintenance of quality system.
2.
Acceptance and Review
(1) Shanghai Food and Drug Administration shall, within
8 working days upon receipt of the materials necessary for such application,
conduct the due review of them, and inform the very applicant in writing of the
materials presented whereby fail to meet requirements or need to be supplemented
with the other relevant materials. The very applicant shall, within the provided
time frame upon receipt of such notice, conduct revision in due course of time.
In case of no revision is made when the provided time frame falls due, the
review will be terminated. Shanghai Food and Drug Administration will, upon
completion of materials review, organize the field assessment or confirm the
exemption wherefrom.
(2) Shanghai Food and Drug Administration shall, within
30 days upon receipt of the complete materials necessary for such application,
issue the Report of Quality System Assessment of Medical Appliance Production
Enterprise, and bring out the outcome of such assessment of "passing assessment"
or "to be re-assessment after revision".
Processing Address: Shanghai
Certification Center of Qualification of Medical Industry, 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 Quality System Assessment by Medical Appliance
Production Enterprises under No. 22 Order of State Food and Drug
Administration.
Contact Tel: 021-62948421
Processing Time: Mondays through
Fridays: 9:00~12:00
Qualified Application Subject: Scope of
Application:
Any and all of enterprises applying for registration of
production permit of Class II/III medical appliances within the territory of
Shanghai Municipality.
Qualifications/Prerequisites for Applicant:
Any and all of medical
appliance production enterprises that are applying for registration of
production permit after 6 months upon registration of product pre-production, or
that are applying for re-registration upon expiration of the original product
registration period.
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