Condoms belong to the second class of medical devices. Engaged in the operation of Class II medical devices, the operating enterprise shall file with the municipal food and drug supervision and administration department located in the district where it is located, and the food and drug supervision and administration department shall verify the completeness of the information submitted by the enterprise on the spot, put it on file if it meets the requirements, and issue a certificate for the operation of Class II medical devices.
Medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related items directly or indirectly used in human body, including required computer software.
Medical instruments include medical equipment and medical consumables.
Utility is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or although these means are involved, they only play an auxiliary role.
The purpose is to diagnose, prevent, monitor, treat or alleviate diseases; Diagnosis, monitoring, treatment, mitigation or functional compensation of injury; Examination, substitution, adjustment or support of physiological structure or process; Support or sustain life; Pregnancy control; By examining human samples, information can be provided for medical or diagnostic purposes.
The medical device industry involves many industries, such as medicine, machinery, electronics, plastics and so on. It is a multi-disciplinary, knowledge-intensive and capital-intensive high-tech industry. The basic characteristics of high-tech medical equipment are digitalization and computerization, which is the crystallization of modern high-tech in many disciplines and fields. Its products have high technical content and high profit, which is the commanding height of competition between major scientific and technological countries and international big companies, and the entry threshold is high. Even in the sub-sectors with low gross profit margin and low input, high-tech products will continue to emerge, from which some enterprises with strong profitability will be bred. Therefore, the overall trend of the industry is high investment and high income.
Legal basis:
Measures for the supervision and administration of medical device operation
Article 3 When engaging in business activities of medical devices, it shall abide by the requirements of laws, regulations, rules, mandatory standards, quality management norms of medical device business, and ensure the truthfulness, accuracy, completeness and traceability of information in the business process of medical devices.
Medical device registrants and filers can sell medical devices by themselves, or they can entrust medical device business enterprises to sell their registered and filed medical devices.