Medical device supervision and management regulations, Article VI, 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.
Medical device instructions should generally include the following:
(a) product name, model, specifications;
(b) the name of the manufacturer, registered address, manufacturing address, contact information and after-sales service units;
(c) "Medical Device Manufacturer License" No. (except for Class I medical devices), the medical device registration Certificate number;
(d) product standard number;
(e) product performance, main structure, scope of application;
(f) contraindications, precautions, and other need for warning or prompt content;
(g) medical device labeling used in the graphic, symbols, abbreviations, and other content of the explanation;
(h) installation and Instructions for use or illustration;
(ix) product maintenance and maintenance methods, special storage conditions, methods;
(j) limited use of the product, should be marked with the expiration date;
(k) product standards should be marked in the instruction manual of other content.
Legal basis:
"Medical Device Registration and Record Management Measures"
Article 3 of the medical device registration refers to the applicant for medical device registration (hereinafter referred to as the applicant) in accordance with the statutory procedures and requirements for the application for the registration of medical devices, the drug supervision and management departments in accordance with the laws and regulations. /strong>, based on scientific knowledge, safety, efficacy and quality control review, decide whether to agree with its application 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 filing information, drug supervision and management department of the filing of information submitted for the record of the activities.