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Processing Authority: Standard Room under Shanghai Medical Appliance
Inspection Institute
Processing Procedures:
1. Acceptance
Presenting
the relevant materials necessary for such application subject to the applicable
provisions. See the Table of Materials for Application for Review of Standards
for Medical Appliance To-be-registered Products in Shanghai for details. The
acceptor shall conduct the form review of such materials, and, in case of
meeting requirements, issue the Notice of Acceptance of Review of Standard for
Medical Appliance To-be-registered Product in Shanghai.
2. Review of
Standard
(1) In case the standard text need to be amended during review, the
acceptor will, upon opinion of review by the inspector reviewed by the competent
leader whereof, issue the one-off Notice of Opinion of Review of Standard for
Medical Appliance To-be-registered Product in Shanghai to the very applicant who
shall, within 30 working days upon receipt whereof, amend it in due course of
time. The time frame of review shall be suspended in case of amendment. In case
the very applicant fails to complete amendment by the deadline whereof, the
review shall be terminated. A new application shall not be made in 3 months. In
case the very enterprise is unable to draft the standard for the
to-be-registered product, such application can be made by the professional
technical service agency with the due qualification on behalf of it.
(2) With
regard to the important and newly-formulated standard for the to-be-registered
product, in case of the disputable technical and/or registration-related
problems, the very enterprise may, prior to or during review of the very
standard, apply to Medical Appliance Registration Office of Shanghai Food and
Drug Administration for convening the "Meeting of Registration Pre-review
(Coordination)" which will, upon approval, invite the relevant experts and
review and inspection personnel of the relevant majors to determine the
disputable matters together.
3. Confirmation of Review of Standard
The
standard for the to-be-registered product passing the review shall be confirmed
by stamping the seal for review of standard for the to-be-registered
product.
Processing Address: Shanghai Medical Appliance Inspection Institute, No. 154,
Minhe Road, Shanghai
Processing Basis:
1. Regulations on Supervision and
Administration of Medical Appliances under No. 276 Order of State Council;
2.
Rules of Classification of Medical Appliances under No. 15 Order of State Food
and Drug Administration; and
3. Regulations for Administration of Standards
for Medical Appliances (for Trial Implementation) under No. 31 Order of State
Food and Drug Administration.
Contact Tel: 021―56631157
Processing Time: Mondays, Wednesdays, and
Thursdays: 9:00~11:00 and 13:00~16:00
Time Limit for Processing: The period
since the confirmation of acceptance of application to making of the result of
review and notification of the applicant shall be 20 working days, and the
period for amendment, revision, and confirmation of the standard shall be 10
working days. The time frame for review of the standard for the very product
shall be suspended during review consultation by experts.
Qualified
Application Subject: Scope of Application:
Any and all of standards for the
to-be-registered products during registration of medical appliances (not
including the directly adopted state standard or industrial standard).
Qualifications/Prerequisites for Applicant:
1. The product described in
the standard for the to-be-registered product shall accord with Class II/III
medical appliance product defined by the Regulations on Supervision and
Administration of Medical Appliances;
2. The very enterprise has completed
the self-test and verification of the standard for the to-be-registered
product;
3. The standard for the to-be-registered product shall in conformity
with the relevant medical appliance state standard and industrial standard;
and
4. The drafting format of the standard for the to-be-registered product
shall accord with the Notice on Implementation of Measures for Administration of
Standards for Medical Appliances under Guo Yao Jian Xie [2002] No. 223 and the
Notice on Issue of Drafting Format of Standards for Medical Appliance
To-be-registered Products under Guo Yao Jian Xie [2002] No. 407.
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