Medical device inspection does not need to take the relevant certificates, but the inspector must meet the prescribed conditions, as follows:
According to the "Medical Device Inspection Organization accreditation conditions":
Article XIV: Inspection organizations should have with the testing activities carried out by the appropriate management personnel and key technical personnel.
(a) managers should have knowledge of the management of testing organizations, familiar with medical device-related laws and regulations and inspection risk management methods.
(b) key technical personnel, including technical personnel, authorized signatories and test report interpretation. Key technical personnel should have a relevant field of professional and technical titles, or master's degree or above, and has more than 5 years of technical work experience in related fields.
Article 15: The inspection agency shall have sufficient inspection personnel, their number, technical skills, educational background should be matched with the test activities carried out, and meet the following requirements:
(a) the inspection personnel should be formally employed, and can only be practiced in the inspection agency. With intermediate or higher professional and technical titles of the number of personnel should be not less than 50% of the total number of personnel engaged in testing activities.
(2) inspectors should be familiar with medical device-related laws and regulations, standards and product technical requirements, master the principles of testing methods, testing skills, operating instructions, quality control requirements, laboratory safety and protection knowledge, measurement and data processing knowledge, and should be after the relevant laws and regulations of medical devices, quality management and related professional and technical training and assessment.
(C) inspectors should have the ability to confirm and pre-evaluation of the technical requirements of the products used, should be able to carry out testing activities in accordance with the prescribed procedures.
(d) engaged in specific state inspection activities should be qualified to obtain the relevant laws and regulations.
Note: medical equipment testing standards are divided into national standards, industry standards and registered product standards. National standards or industry standards refers to the need to standardize technical requirements throughout the country. Registered product standards are developed by the manufacturer, should be able to ensure that the product is safe and effective, and in the product application for registration, by the municipal drug supervision and management department based on the national standards and industry standards for the relevant requirements of the review of product standards.
Expanded Information:
Medical device inspection object:
Medical equipment is an important symbol of the degree of modernization, is the medical, scientific research, teaching and research, teaching the work of the most basic elements, but also constantly improve the level of medical science and technology of the basic conditions, the broader sense of the medical equipment, including medical equipment, home medical equipment, and professional medical equipment. Excluding home medical equipment instruments.
Medical equipment refers to the human body alone or in combination with the use of instruments, equipment, apparatus, materials or other items, including the required software; its use in the human body and the body's role is not pharmacological, immunological or metabolic means of obtaining, but there may be these means to participate in and play a certain role in assisting. Medical devices differ according to the nature of the object they measure.
To measure or monitor the human body in the physical or chemical quantities of medical testing equipment, monitoring equipment or automatic analysis and diagnosis system. Such as electrocardiograph, electroencephalograph, impedance blood flow meter, electrooculograph, monitor. Used to measure or monitor the human body body system on the external signal source absorption, reflection, attenuation and other response degree, indirectly measure or monitor the human body physiological and pathological parameters of medical equipment.
Such as X-ray machine, CT machine, B ultrasound, angiography machine. Used for treatment, measurement or monitoring of its dose safety threshold of the therapeutic instrument or automatic treatment device. Such as a variety of physical therapy machine, laser knife, high voltage defibrillator, worker heart-lung machine, myoelectric control artificial prosthesis.
Baidu Encyclopedia-Medical Device Inspection Organization Qualification Conditions
Baidu Encyclopedia-Medical Device Inspection