Legal analysis: according to the "Chinese people's *** and the Standardization Law" relevant provisions, the need for national unity of technical requirements should be developed national standards; no national standards and the need for national unity of technical requirements within a certain industry, you can develop industry standards. Protection of human health, personal and property safety standards and laws and administrative regulations provide for the mandatory implementation of standards is mandatory, other standards are recommended standards. Mandatory standards must be implemented.
"Supervision and Administration of Medical Devices Regulations" Article VI provides that medical device products should be in line with the mandatory national standards for medical devices; there is no mandatory national standards, should be in line with the mandatory industry standards for medical devices. And in the registration management, it is clearly stipulated that "the mandatory standards for medical devices have been revised, apply for renewal of registration of medical devices can not meet the new requirements," not renewed registration.
Mandatory national standards for medical devices can be found on the website of the National Standardization Administration (www.sac.gov.cn). Mandatory industry standards for medical devices in the State Food and Drug Administration website (www.cfda.gov.cn) data query "mandatory industry standards for medical devices" column query, or in the State Food and Drug Administration Medical Device Standards Management Center website (www.nicpbp.org.) standards and supplementary test methods. cn) standards and supplemental test method query "device mandatory industry standards" column query.
Legal basis: "Medical Device Registration and Record Management Measures" Article 3 Medical device registration refers to the applicant for registration of medical devices (hereinafter referred to as the applicant) in accordance with the statutory procedures and requirements for the application for registration of medical devices, drug supervision and management departments in accordance with laws and regulations, based on scientific knowledge, safety, efficacy and quality control and other reviews, and to decide whether or not to agree with the application of the activities.
Medical device filing refers to the medical device filer (hereinafter referred to as the filer) in accordance with the statutory procedures and requirements to the drug supervision and management department to submit the record information, drug supervision and management department of the filing of information submitted for the record of the activities of the archives.