Legal analysis: is the "medical electrical equipment," the safety of the series of standards, the content of the standard is the first part of the safety of the general standards; the second part is the safety of special requirements. Part 1 in addition to the general requirements of this safety standard also includes a number of parallel standards, the current IEC international standard equivalent into our standards are: GB9706.12-1997 medical electrical equipment.
Legal basis: "supervision and management of medical devices regulations"
Article XIII of the first class of medical devices for the record management of products, the second class, the third class of medical devices for the implementation of product registration management.
Medical device registrants, filers should strengthen the quality management of medical devices throughout the life cycle of the development, production, operation, use of the whole process of medical devices, safety, effectiveness and bear responsibility according to law.
Article XV of the first class of medical device products for the record, by the filer to the municipal people's government in charge of drug supervision and management of the location of the municipal people's government to submit the filing information.
To China's exports of Class I medical devices outside the filer, by its designated enterprise legal person in China to the State Council drug supervision and management department to submit the filing information and the filer's country (region) the competent authorities to permit the sale of the medical device on the market documents. Innovative medical devices not listed outside the country, can not submit the filer's country (region) competent authorities to authorize the marketing of the medical device documents.
The filer submits to the department in charge of drug supervision and management of the filing information in accordance with the provisions of these regulations will be completed after the filing. Supervision and management of drugs should be responsible for drug supervision and management of the department shall be received from the date of filing information within five working days, through the State Council drug supervision and management of online government services platform to the community to announce the filing of relevant information.
Filing information contained in the matter of change, should be filed to the original record department to change the record.