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Processing Authority: Shanghai Medical Appliance
Inspection Institute
Application Formalities: relevant materials
1. the
letter or contract of authorization of inspection;
2. the requirement for
exempting from inspection of the very medical appliance product by third party;
and
3. frequently problems arising out of such inspection.
Processing
Procedures:
1. Application for Inspection of Medical Appliance
To-be-registered Products
(1) presenting the standard and relevant materials
for the Medical Appliance To-be-registered Product;
(2) presenting the report
of self-inspection by the very enterprise; and
(3) concluding the letter or
contract of authorization.
2. Presenting Prototype for Inspection
(1) With
regard to prototype for registration of pre-production, the very applicant
shall, subject to the inspection rules in the registration norm, independently
send the prototype to the acceptance office of Shanghai Medical Appliance
Inspection Institute and conduct any and all of formalities necessary for
take-over of the to-be inspected prototype.
(2) With regard to prototype for
registration of production permit/re-registration, the sampling personnel
assigned by the inspection unit shall go to the applicant, and, subject to the
inspection rules in the registration norm, sample certain quantity of prototypes
and seal them. The prototypes sampled for inspection shall be products passing
the ex works inspection, and can be brought back to the inspection unit by the
sampling personnel, or sent back to the inspection unit by the applicant where
any and all of formalities necessary for take-over whereof.
3. Inspection of
Prototypes
(1) During inspection of prototypes for registration of the
pre-production, the applicant shall, upon receipt of the notice that the
inspected prototypes do not accord with the standard for product, confirm the
result of such inspection. In case the existing problems confirms that the
product do not pass the inspection, the very inspection of registration of
pre-production shall be terminated. In case the applicant intends to continue
the very inspection, the type of inspection shall be shifted to the inspection
on commission, and a new letter or contract of authorization shall be
concluded.
(2) In case the inspection of prototypes of production permit/re-
registration is conducted to the matured products that have obtained the
certificate of registration, the inspection for changing certificate shall, in
principle, be complete one-off. In case the prototype fails in the very
inspection, the result of such inspection shall be reported to Medical Appliance
Registration Office under Shanghai Food and Drug Administration for record
filing.
Charging Standard and Basis: Review charges shall be determined
subject to the quantity of the specific inspection items, the complicacy of the
very product, the inspection devices, the inspection time, taxation, and other
elements by concluding a contract wherefor.
Processing Address: Shanghai
Medical Appliance Inspection Institute, F/2, No. 154, Minhe Road,
Shanghai
Contact Tel: 021－56635850－2201,
021-56631157
Processing Time: Mondays through Thursdays: 9:00~11:30 and
12:30~16:00
Fridays: 9:00~11:30
Time Limit for Processing: The time limit
for inspection shall be determined by the very applicant and the inspection unit
through concluding a inspection contract subject to the quantity and complexity
of the inspection items of the very medical appliance products. The time limit
for inspection provided in such contract shall not, to the largest extent,
exceed 60 working days.
Qualified Application Subject: the technical
inspection during pre-production, production permit or re-registration of
medical appliances. The inspection activities shall be implemented after the
very applicant for registration and the inspection institute have concluded a
contract wherefor.
Qualifications/Prerequisites for Applicant:
1. The
standard for the to-be-registered product has passed the technical review;
and
2. The quantity, packaging, and supporting documents of the
to-be-inspected prototypes shall meet the applicable requirements, and
accessories and the consumables whereof shall be provided, if
necessary.
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