Provision on the Registration and Inspection of Imported Medical Device and Apparatus

Article 1 For the standardization of registration and inspection tasks of imported Medical      Device and apparatus, the Provision is formulated in accordance with “Administrative Ordinances on the Supervision of Medical Device and Apparatus” and “Administrative Procedure on the Registration of Medical Device and Apparatus”. Every institution applying for registration and every inspection institution shall observe and comply with the Provision.

Article 2 Scope of Applicability

   The Provision is applicable to the Medical Device and apparatus possessing the certificate of permission to enter the market approved from the relevant authority on the Medical Device and apparatus of the country (region) of origin.

Article 3 Purpose of Inspection

   Prior the registration, exclusive inspection and verification specific for imported Medical Device and apparatus are carried out, ensuring the safety and effectiveness of the marketed product. Through inspection, affirmation of the quality of the product has met the promised technical indices is completed, which shall be used as the technical basis for supervision administration.

Article 4 Obligation of Inspection Institution
   1. Examination and review of the standard of the registered product;
   2. Carry out inspection in accordance with the affirmed standard of registered products and issue the inspection report.

Article 5 Affirmation of Inspection Institution
    1. The institution in charge of inspection must be an inspection institution affirmed and accredited by State Drug Administration.
    2. The product undergoing inspection by the inspection institution shall be within the scope of the inspection list of that inspection institution affirmed by State Drug Administration.
    3. For product not included in any of the inspection list from each of the inspection institution, the relevant registration authority shall designate and appoint other inspection institution to bear the responsibility of inspection, or shall be executed in accordance with the terms specified under Article Ten.
    4. The institution applying for the inspection may select the inspection institution on its own discretion from the institutions possessing the inspection capability as affirmed by State Drug Administration. During the process of inspection, should the institution carrying out the inspection fail to meet the regulation in the aspects of time limit of work and inspection capability, the institution applying for the registration may select another inspection institution in accordance with the terms stipulated under Item VI of this Article.

Article 6 Item of Inspection
    1. Index of safety performance is a required item of inspection;
    2. Index of major performance is a required item of inspection;
    3. Index of general performance is an optional item of inspection。
    4. For products already received inspections on the above-mentioned Items I, II, and III, and have no customer’s complaints in the Chinese market, only the modified performance index need to be inspected when undergoing new registration.

    Should the testin g time of the indices listed in Item I and II require more than 30 days for any individual testing, the testing may have to be carried out. The enterprise shall provide the affirmed inspection report on that item of the product from the country of origin. The institution carrying out the inspection shall undergo affirmation and accreditation of the inspection report from the country of origin.

    Should the testing item belong to the national mandatory safety index, destructive testing must be conducted. Should it be a general performance index, then the testing is not conducted. Should the inspection institution believe it is necessary to carry out testing on other indices, the testing shall be conducted after approval from the relevant registration authority.

Article 7 Basis of Inspection
    1. National standard;
    2. Industry standard;
    3. The standard of registered product provided by the enterprise.

    The standard of registered product provided by the enterprise may be divided into the following three methods:
    1. Itemize and summarize in accordance with the existing information of the enterprise;
    2. Current standard and specification shall be provided by the enterprise;
    3. Finished product inspection report and a third party inspection report (must include safety index and major performance indices) shall be provided by the enterprise.

Article 8 Requirement of Examination and Review of Standard of Registered Product
    1. Through examination and review of registered product standard, performance index must meet the specification of the mandatory national standard and industry standard of our nation;
    2. Examination and review of registered product standard may refer to the product standard of the similar products marketed in our nation;
    3. Examination and review of registered product standard shall accept (stipulated in Article Seven) any one of the 3 methods provided by the enterprise regarding the registered product standard;
    4. The technical parameters in the registered product standard shall conform to the technical parameters listed in the user’s manual of the product provided by the enterprise;
    5. The time limit of the examination and review of standard shall be 7 days starting from the date of acceptance. Should the provided information fail to meet the requirement, the time of submitting additional information shall not be included in the time limit.

Article 9 Inspection Report
    1. The column of inspection type must be: import registration inspection.
    2. The conclusion of inspection report shall be: “Meet the affirmed registration product standard” or “Some item(s) fail to meet the affirmed registered product standard”.
    3. The inspection report shall be signed and affixed with seal by the handler, inspector, and the director of inspection institution.
    4. The inspection report shall be true and factual. Should the inspection report have any falsification or fabrication, State Drug Administration shall suspend the inspection qualification of the inspection institution.

Article 10 Inspection Method
    1. Domestic inspection.
    2. Accepted and accredited oversea inspection report. Should the inspection list of each inspection institution do not consist of the product applying for registration, or the inspection institution cannot provide the necessary inspection equipment and facility to carry out the inspection in accordance with the standard of the registered product, after examination and approval from the relevant registration authority, the relevant registration authority may organize experts to undergo review and acceptance of the oversea inspection report from the applying institution.
     3. Implementation of oversea inspection. Should our nation fail to have the necessary inspection instrument, facility, and the professional personnel to carry out the on site inspection of the oversea manufacturing quality system of the product, the affirmed oversea on site inspection of the imported product may be implemented to replace the domestic inspection.

Article 11 Time Limit of Inspection and Acceptance Time Limit of Oversea Inspection Report

    Time limit of inspection shall be 45 working days. Time limit of affirmation of oversea inspection report shall be 10 working days.

Article 12 Quantity of Sample Used for Inspection

    Disposable Medical Device and apparatus (not including high value catheter products): no more than 30;

   Artificial lens and contact lens: no more than 50;

   Implantable products and high value catheter products: no more than 5;

   Medium-small size equipment products: no more than 2;

   Large size equipment: 1.

   Should the inspection of important performance indices cannot be implemented due to the limited quantity of the samples, the affirmed inspection report from the government of the country of origin may be provided and shall be affirmed by the inspection institution.

   Should there be a need to increase the quantity of samples due to the need of inspection, the inspection may be implemented after submission of the request from the inspection institution and approval from the relevant registration department. Should products with multiple models be applying for registrations concurrently, the classification of inspection units shall be classified in accordance with the registration units. Every registration unit shall select one classic sample to undergo inspection.

Article 13 Inspection Fee
     1. The inspection institution shall charge the fee in accordance with the approved charging standard determined by the local provincial pricing authority.
     2. The inspection institution shall submit the charging standard to State Drug Administration for record.
     3. The charging standard of the inspection institution shall be posted and publicized. The institution applying for registration may decline to accept any charging standard that is not posted and publicized.

Article 14 Reexamination of Inspection Report

    Should the enterprise have any doubt regarding the result of inspection, it shall advance a request for reexamination to the relevant registration authority. Should the relevant registration authority believe it is necessary, reexamination of inspection shall be arranged.

Article 15 Work Discipline
     1. Inspection institution shall comply with the principles of openness, fairness, and righteousness to implement registration inspection.
     2. Should inspection institution and the relevant personnel violate the inspection regulations, disciplinary action shall be enforced in accordance with the relevant regulations.

Article 16 The Provision shall be interpreted by State Drug Administration.

Article 17 The Provision shall be implemented on the date of printing and distribution.

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