Provision of Implementation on the Inspection of Quality System of the Oversea Medical Device Manufacturing Enterprises

Article 1 For the strengthening of supervision administration on medical device and assurance of the safety and effectiveness of import medical device, the Provision is formulated in accordance with “Regulations for the Supervision and Administration of Medical Device” and “Provision on Medical Device Registration”.

Article 2 For Class III medical device which has received the permission to market and distribution from the relevant authority of the country of origin, the registration examination shall carry out the oversea on site examination for the manufacturing enterprise quality system.

Article 3 The effective period of on site examination result for the manufacturing enterprise shall be 4 years. For similar types of products included in the qualified system, the examination shall not repeat on site examination during the application for registration.

Article 4 State Drug Administration shall be responsible to organize and implement the examination of quality system for oversea medical device manufacturing enterprises.

Article 5 Time Limit of Examination

    After receiving the examed application materials from the technical examination and evaluation authority, the relevant registration authority shall undergo scheduling of examination of the system and shall notify the applicant. The examination of the system shall be executed within 50 working days.

Article 6 Technical Basis of Examination on the Quality System for Manufacturing Enterprise

   “Quality System Mode of Quality Assurance of Design, Development, Manufacturing, Installation, and Service” (GB/T 19001), “Quality System Special Requirements of GB/T 19001 ISO 9001 on Medical device” (YY/T0287), and the relevant general safety requirement or product standard; or “Quality System Mode of Quality Assurance of Design, Development, Manufacturing, Installation, and Service” (GB/T 19002), “Quality System Special Requirements of GB/T 19002 ISO 9002 on Medical device” (YY/T0288), and the relevant general safety requirement or product standard.

Article 7 Examination Obligation

• Shall make a comprehensive evaluation on the assurance capability of the quality system of manufacturing process;
• Shall submit examination report of quality system of oversea enterprise.

Article 8 Qualification of Examination Personnel

   Examination personnel shall possess the following abilities concurrently:
     1. Engage in technical works of medical device or administrative management works;
     2. Possess the ability to independently carry out examination of the system;
     3. Have received training and qualification certificate from examination of quality system for medical device manufacturing enterprise;
     4. Posses training certificate on examination of oversea quality system of medical device and apparatuses;
     5. Have the necessary ability and understanding of foreign language.

Article 9 Formation of Examination Team

     The examination team generally consists of 2 to 3 people, which shall be formed by examination team leader and examination team personnel. Examination team leader shall be responsible for the entire process of examination.

Article 10 Examination Process

    I. Preparation

    Accept the mission of examination from the relevant registration authority, read the relevant registration documents, familiarize the registration product and product standard, understand enterprise situation, advance examination keys and examination schedule in writing.

   II. First Meeting

    The leader of examination team shall preside over the first meeting. The principal person, managers, and responsible personnel of major departments of the enterprise under examination shall attend the meeting.
    1. Introduction of personnel of examination team to the party under examination. The party under examination shall introduce the personnel attending the meeting ;
    2. Declaration of purpose, scope, and basis of examination;
    3. Brief description of method and procedure used during examination;
    4. Notification of examination schedule;
    5. Both parties shall affirm examination process;
    6. Declaration of secrets protection.

    III. Examination
    1. Objective evidences shall be collected and recorded in accordance with the examination chart through methods, such as interview, questioning, document inspection, on site observation, and testing;
    2. All objective evidences shall be noted in writings for unqualified items. All unqualified facts shall be affirmed by the party under examination;
    3. Fill out the examination report (the party under examination shall not be present).

    IV. Final Meeting

     Examination team leader shall preside over the final meeting. The personnel who attended the first meeting from the party under examination shall attend the meeting.
    1. Reiteration of the purpose, scope, and basis of examination;
    2. Explanation of unqualified facts discovered during the examination;
    3. Description of overall evaluation of examination;
    4. The principal person from the party under examination shall affirm and sign the examination report.

     V. Report oversea works

    All personnel of examination team shall report the examination result and working situation abroad to the dispatch institution.
     VI. Should the party under examination have objection regarding examination result, the examination personnel shall bring back the materials and evidences of unqualified items, and the ruling shall be arranged by the relevant registration authority.

Article 11 Requirement and Discipline Stipulation of Examination Personnel
     1. The examination personnel shall strictly execute the examination process and responsibility stipulation of examination.
     2. After receiving the mission of examination of oversea system, the examination personnel shall promptly contact the applicant and shall coordinate and arrange the schedule in accordance with the examination period specified by the approval document.
     3. The examination personnel shall submit the summary and the examination report chart of the oversea system to the relevant registration authority after completion of mission.
     4. The examination personnel shall protect benefits and interests of nation during the outbound period and shall maintain excellent image of examination personnel.
     5. Must keep and protect national secret.
     6. Must comply with stipulation of probity and self-discipline.
     7. Must comply with every requirement of the discipline for foreign affairs.
     8. Should examination personnel violate examination regulation, State Drug Administration shall suspend its examination qualification and shall hand-over the matter to the relevant authority for anyone severely violate the discipline for foreign affairs.

Article 12 The Provision shall be interpreted by State Drug Administration.

Article 13 The Provision shall be implemented on the date of printing and distribution.

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