According to the interpretation of product quality law, product quality refers to the sum of the characteristics and characteristics of products such as effectiveness, safety, applicability, reliability, maintainability, economy and environment. The quality characteristics of different products have different emphases. Medical devices are special products related to people's lives and health, and their basic quality characteristics are safety and effectiveness.
(1) Safety of medical devices. There are two basic safety requirements:
(1) Safety requirements for medical electrical equipment refer to medical devices driven by electricity (AC power supply or DC power supply).
② For medical devices without power supply, such as medical devices implanted in human body and disposable medical supplies.
(2) The effectiveness of medical devices. Any commodity has its corresponding performance. As a special commodity used in human body, it is important whether it can really achieve the purpose of effective diagnosis and treatment and disease prevention mentioned in the manual. The performance of medical devices is also the effectiveness of clinical use.
Supervision and management of medical devices
(1) Medical device product registration. Medical device product registration shall be classified:
(a) a class of products for the record, after examination and approval by the municipal government drug administration, issued a product registration certificate.
② Class II and III products are registered, and the procedures are mostly substantive examination. In the process of implementation, the second and third types of product registration are divided into trial product registration and quasi-product registration system.
(3) The product registration of Category II products shall be examined and approved by the drug administrations of provinces and municipalities directly under the Central Government and issued with product registration certificates, while the product registration of Category III products shall be examined and approved by the State Pharmaceutical Product Supervision Administration and issued with product registration certificates.
Imported medical devices shall be examined and approved by the State Administration of Pharmaceutical Products, and the Registration Certificate of Imported Medical Devices shall be issued.
(2) supervision and spot check of medical device products.
① Evaluation, supervision and spot check: quality evaluation and comprehensive evaluation of the same variety or similar products.
(2) Targeted supervision and spot check: conduct supervision and spot check on medical devices with quality complaints, reports or unqualified records in quality supervision and spot check.
Supervision and spot checks are divided into national supervision and spot checks and provincial supervision and spot checks. The State Administration of Medical Devices is responsible for the supervision and spot check of national medical devices nationwide, and the provincial (municipality directly under the Central Government) drug administration is responsible for the supervision and spot check of medical devices within the province (municipality directly under the Central Government).
The column of licensed pharmacist examination is recommended to you:
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