The medical device inspection institutes are nominated by CFDA directly and are responsible for the examination and evaluation of the premarket product’s safety and effectiveness in the record or registration procedure. Based on the <Regulations for The Supervision and Administration of Medical Devices>, CFDA enacted the <Qualification Determination for Medical Device Inspection Institute>, that is, following sections have to meet the qualification standard in the establishment of a medical device inspection institute:
- Management system
- Inspection ability and methods
- Facilities and Setting
- Instruments and Equipment
- Disposition of Samples
The inspection institutes those apply for qualification determination shall comply with following requirements:
- Institute shall be capable of bearing legal liability independently, and guarantee the objectives, justness and independence when carry out the inspection activities.
- All carried out inspection activities shall already pass the laboratory qualification determination.
- Institute that conduct inspection in specific field shall obtain the relevant qualification determination. For instance, institute that work on the animal experiments, shall get the <Occupancy Permit for Animal Experiment> released by Animal Experiment Administration Department.
- Other requirements pursuant to law.
Inspection institutes are required to establish and implement the quality system adaptive to inspection activities and other management system dossiers, including policy, project plan, procedure, product standards (technical requirements), operation instruction, risk analysis, safety regulations, etc. Management system shall be implemented validly and under control.
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Inspection Ability and Methods
Inspection institute shall possess the inspection ability for product standards, product safety and effectiveness, and vital properties of the product. If the inspection activity involves several technical categories, such as biological evaluation, electromagnetic compatibility property and animal experiment, thus the inspection institute shall meet the corresponding required standards and abilities respectively. Additionally, the inspection institute shall be able to conduct the analysis and evaluation for medical device quality accidents.
Inspection institutes shall possess and adopt the inspection methods released by the latest national standards, professional standards, product standards, known technology institute and scientific journals, and shall possess the ability to conduct pre-assessment and guarantee for the inspection method.
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Inspection institutes shall employee following staffs for completing the inspection activities:
- Manager: Shall be equipped with managerial knowledge, familiar with the regulations for medical device and test the method of risk prevention and control.
- Main Technicians: Shall include technical director, authorized signatory, test report explainer and so on. Main technicians shall possess the senior professional and technical titles or equivalent technical competence in corresponding fields, and have more than 5 years work experience.
Inspection Personnel: The number, technical competence and education background of the inspection personnel shall be matched with inspection activities, the requirements of the inspection personnel are as follows:
1) The inspection personnel must be the official employee and only permitted to work in single inspection institute, the ratio of inspection personnel those own the junior professional and technical titles cannot be lower than 50%. 2) The inspection personnel shall be familiar with the regulations, product standards, inspection methods mechanism, quality control requirements, laboratory safety and prevention for medical device, and skilled in inspection operation, procedure and data processing. 3) The inspection personnel shall be able to guarantee and pre-assess the product standards, be able to determine the hazard of the medical device according to the established procedure, and be able to give the risk assessment report. 4) The inspection personnel shall obtain the corresponding practicing certificate if it is required for the inspection activity. For example, who work for the animal experiments must get the <Animal Experiment Employee Certificate>.
Facilities and setting of the inspection institute shall satisfy following requirements:
- The inspection institute shall possess the steady and independent working site, which can able to meet the demand of inspection activities.
- The basic facilities and setting of the inspection institute shall satisfy the demand of inspection methods, instrument regular operation, storage for technical dossiers, preparation and storage for samples, preventing cross contamination, warranty for people healthy and environmental protections.
- The inspection institute shall be equipped with the facilities and setting that can achieve the laboratory condition, data analysis and information transmission for inspection activities, in order to ensure the accuracy of the inspection results.
- The experimental areas shall be isolated from non-experimental areas, adjacent area those will influence each other shall be isolated as well, the warning of controlled area and hazardous area shall be indicated obviously.
- The laboratory shall possess the facility that can store and dispose the waste samples.
- The laboratory that carry out the inspection in specific field shall possess the specific facilities and setting, such as biological property and safety evaluation lab, animal experiment lab, electromagnetic compatibility testing lab etc.
- The inspection institute shall possess the instruments and equipments based on the <Basic Instrument and Equipment Standard for National Medical Device Inspection Institute>.
- The inspection institute shall be equipped with independent and fixed/mobile instrument and equipment that is capable of carrying out the inspection activity. The documents, operation instruction, calibration plan, approval, use and repair record of the significant instrument and equipment shall be established and kept.
- The instrument and equipment must be managed and use by authorizer.
The inspection institute shall establish and implement the management and disposition procedure for samples to guarantee the status and control of samples, and assure that samples will not be reused. The storage and disposition of samples shall satisfy the demand of environment protection and customer’s confidentiality.
Inspection institute shall establish the tag system for samples as well, to ensure the reservation of samples in the laboratory.