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Processing Authority: Shanghai Drug and Medical Appliance Review and
Assessment Center
Processing Procedures:
Registration of Production Permit
of Class I Medical Appliances
Re-registration of Class I Medical
Appliances
Registration of Pre-production of Class II Medical
Appliances
Registration of Pre-production to Production Permit of Class II
Medical Appliances
Re-registration of Class II Medical
Appliances
Registration of Direct Production Permit of Class II Medical
Appliances
1 Registration of Production Permit of Class I Medical Appliances
1. The
very applicant formulates the standard for the very product to be registered
independently;
2. The very applicant conducts the overall self-check of
performance of the very product; and
3. Presenting the materials necessary
for application. The very applicant shall present to Acceptance Window of
Shanghai Drug and Medical Appliance Review and Assessment Center any and all of
materials necessary for such application for registration of the very product,
which shall cover the application from for registration of medical appliance,
the supporting document for qualification of medical appliance production
enterprise, the standard for the very product to be registered and formulation
specification whereof, the self-check report of the overall performance of the
very product, the illustration of the existing resources supplies and quality
management capacity of the enterprise production (including the measures for
checkout), the operation instruction of the very product, and the statement of
self-guarantee of the trueness of materials presented whereby. Shanghai Food and
Drug Administration will, upon due review and approval, issue the Certificate of
Registration of Medical Appliance of the People's Republic of China to the very
applicant.
2 Re-registration of Class I Medical Appliances
1. The very
applicant amends or revises the standard for the very product to be registered
independently;
2. Presenting the materials necessary for application. The
very applicant shall present to Acceptance Window of Shanghai Drug and Medical
Appliance Review and Assessment Center any and all of materials necessary for
such application for registration of the very product, which shall cover the
application from for registration of medical appliance, the supporting document
for qualification of medical appliance production enterprise, the xerox copy of
the original certificate of registration of production permit, the standard for
the very product to be registered, the illustration of the existing resources
supplies and quality management capacity of the enterprise production (including
the measures for checkout), the operation instruction of the very product, the
report of the quality follow-up of the very product, and the statement of
self-guarantee of the trueness of materials presented whereby.
3. Shanghai
Food and Drug Administration will, upon due review and approval, issue the
Certificate of Registration of Medical Appliance of the People's Republic of
China to the very applicant.
3 Registration of Pre-production of Class II
Medical Appliances
1. Formulating the standard of the very product and
passing the review whereof. The applicant shall independently formulate the
standard for the very medical appliance to-be-registered product and pass the
review of the standard wherefor by the standard review authority. See the Notice
of Shanghai Municipality on Review of Standard for Medical Appliance
To-be-registered Products for detailed procedures.
2. Conducting Product
Inspection. The prototype or sample of the to-be-registered product shall
undergo a product performance self-test, and, upon passing such self-test, a
form inspection of registration of pre-production subject to requirements of the
standard for the to-be-registered product. See the Notice of Shanghai
Municipality on Inspection of Medical Appliance To-be-registered Products for
detailed procedures.
3. Conducting clinical test or verification. The very
product shall, upon passing the review of standard and form inspection, undergo
the clinical test or verification in the clinical base recognized by State Food
and Drug Administration. See the Notice of Shanghai Municipality on Clinical
Test of Medical Appliances for detailed procedures.
4. Applying for
registration. The very applicant shall present to Acceptance Window of Shanghai
Drug and Medical Appliance Review and Assessment Center any and all of materials
necessary for such application for registration of the very product, which shall
cover the application from for registration of medical appliance, the supporting
document for qualification of medical appliance production enterprise, the
technical report of the very product, the report of safety analysis of the very
product, the standard for the to-be-registered product and formulation
specification whereof, the self-check report of the overall performance of the
very product, the report of form inspection of registration of pre-production of
the very product, the report of clinical test in more than two clinical test
bases, the operation instruction of the very product, and the statement of
self-guarantee of the trueness of materials presented whereby.
5. Shanghai
Food and Drug Administration will, upon due review and approval, issue the
Certificate of Registration of Medical Appliance of the People's Republic of
China to the very applicant.
4 Registration of Pre-production to Production
Permit of Class II Medical Appliances
1. Amending or revising the standard
for the very product and passing the review whereof. The very applicant shall
amend or review the standard for the medical appliance to-be-registered products
and passing the review of the standard by the standard review authority. See the
Notice of Shanghai Municipality on Review of Standard for Medical Appliance
To-be-registered Products for detailed procedures.
2. Conducting product
inspection. The very product shall, upon undergoing the form inspection of the
registration of pre-production, be subject to requirements of the standard for
to-be-registered products. See the Notice of Shanghai Municipality on Inspection
of Medical Appliance To-be-registered Products for detailed procedures.
3.
Applying for registration. The very applicant shall present to Acceptance Window
of Shanghai Drug and Medical Appliance Review and Assessment Center any and all
of materials necessary for such application for registration of the very
product, which shall cover the application from for registration of medical
appliance, the supporting document for qualification of medical appliance
production enterprise, the xerox copy of the certificate of registration of the
pre-production, the standard for the to-be-registered product, the report of
product improvement within the period of pre-production, the valid supporting
document for the enterprise quality system assessment (certification), the
report of form inspection of registration of production permit of the very
product, the operation instruction of the very product, the report of quality
follow-up of the very product, and the statement of self-guarantee of the
trueness of materials presented whereby. A notice of acceptance will be issued
in case the form review of the materials necessary for application meet
requirements.
4. Shanghai Food and Drug Administration will, upon due review
and approval, issue the Certificate of Registration of Medical Appliance of the
People's Republic of China to the very applicant.
5 Re-registration of Class
II Medical Appliances
1. Amending or revising the standard for the very
product and passing the review whereof. The very applicant shall independently
amend or review the standard for the medical appliance to-be-registered products
and passing the review of the standard by the standard review authority. See the
Notice of Shanghai Municipality on Review of Standard for Medical Appliance
To-be-registered Products for detailed procedures. In case of no change in the
standard for the to-be-registered products, no review by the standard review
authority is needed.
2. Conducting product inspection. The very product
shall, upon undergoing the form inspection of the pre-production registration,
be subject to requirements of the standard for to-be-registered products. See
the Notice of Shanghai Municipality on Inspection of Medical Appliance
To-be-registered Products for detailed procedures.
3. Applying for
registration. The very applicant shall present to Acceptance Window of Shanghai
Drug and Medical Appliance Review and Assessment Center any and all of materials
necessary for such application for registration of the very product, which shall
cover the application from for registration of medical appliance, the supporting
document for qualification of medical appliance production enterprise, the xerox
copy of the original certificate of registration of production permit, the
standard for the to-be-registered product, the valid supporting document for the
enterprise quality system assessment (certification), the report of form
inspection of registration of production permit of the very product, the
operation instruction of the very product, the report of quality follow-up of
the very product, and the statement of self-guarantee of the trueness of
materials presented whereby. A notice of acceptance will be issued in case the
form review of the materials necessary for application meet requirements.
4.
Shanghai Food and Drug Administration will, upon due review and approval, issue
the Certificate of Registration of Medical Appliance of the People's Republic of
China to the very applicant.
6 Registration of Direct Production Permit of
Class II Medical Appliances
1. Formulating the standard for the very product
and passing the review whereof. The very applicant shall independently formulate
the standard for the medical appliance to-be-registered products and passing the
review of the standard by the standard review authority. See the Notice of
Shanghai Municipality on Review of Standard for Medical Appliance
To-be-registered Products for detailed procedures.
2. Conducting Product
Inspection. The prototype or sample of the to-be-registered product shall
undergo a product performance self-test, and, upon passing such self-test, a
form inspection of registration of production permit subject to requirements of
the standard for the to-be-registered product. See the Notice of Shanghai
Municipality on Inspection of Medical Appliance To-be-registered Products for
detailed procedures.
3. Conducting clinical test or verification. The very
product shall, upon passing the review of standard and form inspection, undergo
the clinical test or verification in the clinical base recognized by State Food
and Drug Administration. See the Notice of Shanghai Municipality on Clinical
Test of Medical Appliances for detailed procedures.
4. Applying for
registration. The very applicant shall present to Acceptance Window of Shanghai
Drug and Medical Appliance Review and Assessment Center any and all of materials
necessary for such application for registration of the very product, which shall
cover the application from for registration of medical appliance, the supporting
document for qualification of medical appliance production enterprise, the
technical report of the very product, the report of the risk analysis of the
very product, the standard for the to-be-registered product and formulation
specification whereof, the self-check report of the performance of the very
product, the report of form inspection of registration of production permit of
the very product, the report of clinical test in more than two clinical test
bases,, the valid supporting document for the enterprise quality system
assessment (certification), the operation instruction of the very product, and
the statement of self-guarantee of the trueness of materials presented whereby.
A notice of acceptance will be issued in case the form review of the materials
necessary for application meet requirements.
Charging Standard and Basis:
Registration of Class I medical appliances: RMB 1,000/item
Registration of
Class II medical appliances: RMB 2,000/item
Processing Address: 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. Rules of Classification of Medical Appliances
under No. 15 Order of State Food and Drug Administration;
3. Measures for
Administration of Registration of Medical Appliances under No. 16 Order of State
Food and Drug Administration;
4. Measures for Quality System Assessment by
Medical Appliance Production Enterprises under No. 22 Order of State Food and
Drug Administration;
5. Regulations for Administration of Standards for
Medical Appliances under No. 30 Order of State Food and Drug
Administration;
6. Measures for Administration of Instructions of Medical
Appliances under No. 31 Order of State Food and Drug Administration;
7.
Regulations for Clinical Tests of Medical Appliances under No. 5 Order of State
Food and Drug Administration;
8. Catalogue of Classification of Medical
Appliances under Guo Yao Jian Xie [2002] No. 302 issued by State Food and Drug
Administration;
9. Supplementary Regulations on Registration of Medical
Appliances (I) under Guo Yao Jian Xie [2002] No. 259 issued by State Food and
Drug Administration;
10. Supplementary Regulations on Registration of Medical
Appliances (II) under Guo Yao Jian Xie [2002] No. 119 issued by State Food and
Drug Administration;
11. Notice on Implementation of Measures for
Administration of Standards for Medical Appliances under Guo Yao Jian Xie [2002]
No. 223; and
12. the document under Hu Cai Zong (1999) No. 28 issued by
Shanghai Finance Bureau.
Contact Tel: 021-62837766-811 or 812,
62830955
Processing Time: Mondays through Thursdays: 9:00~11:30 and
13:30~16:30
Fridays: 9:00~11:30
Time Limit for Processing: Registration of
Class I medical appliances: within 30 working days
Registration of Class II
medical appliances: within 60 working days
Qualified Application Subject:
Scope of Application:
Any and all of production/research entities and medical
institutes applying for registration of production permit of Class I/II medical
appliances within the territory of Shanghai Municipality.
Medical appliances
refer to any and all of instruments, equipments, devices, materials or other
articles that are used to human bodies in separate or combination, including
software needed for such use, the function of which on the surface of and inside
the human bodies are not those obtained by adopting the pharmacological,
immunological, or metabolic measures. However those measures may participate in
and play roles in the certain auxiliary effects. The use whereof is aiming at
the certain anticipated purposes as follows:
1. prevention against, diagnosis
of, treatment of, custody of, and relief from disease;
2. diagnosis of,
treatment of, custody of, relief from, and redemption for trauma or
deformity;
3. study of, substitution for, and regulation of dissecting or
physiological process; and
4. gestation control.
Qualifications/Prerequisites for Applicant:
1. The product applying for
registration has been listed in the Catalogue of Classification of Medical
Appliance Products of China, or accords with the above definition for medical
appliances.
2. Any application for registration of pre-production shall be
subject to the prerequisite of obtaining the Notice of Permit of Business Start
of Medical Appliance Production Enterprise.
3. Any application for
registration of production permit shall be subject to the prerequisite of
obtaining the Form of Record Filing of Medical Appliance Production Enterprise
or Notice of Permit of Business Start of Medical Appliance Production
Enterprise.
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