Municipal food and drug supervision bureau has issued the Beijing medical equipment sales network supervision measures for the administration of detailed rules for the implementation (try out) ", this simplified enterprise business processes, and optimize the business environment, regulatory functions changing at the same time, strengthen the matter later regulation, optimize network management order.
Medical equipment is directly or indirectly to the body's instrument, equipment, instruments, in vitro diagnostic reagents and calibration, materials, and other similar or related items, including computer software that is needed.In daily life, there are two kinds of common medical devices, home and medical.Common household medical devices include contact lenses, blood pressure monitors, blood glucose meters, ventilators, pregnancy test papers, medical devices and rehabilitation AIDS.Common medical medical devices include: medical gloves, syringes, monitor, anesthesia machine, stents, orthopaedic metal materials, ultrasonic instrument (colour to exceed, B to wait), X-ray machine, nuclear magnetic resonance instrument, etc.
In Beijing, there are a large number of business entities in the medical device e-commerce industry, a large overall transaction scale and a continuously active capital market.In order to promote the healthy development of the medical device e-commerce industry, the "detailed rules" adopt more detailed management methods, and put forward specific requirements for the online sales and trading services and supervision and management of medical devices.Medical equipment electrical contractor must follow the principle of 'online consistent, according to the original medical instrument electricity policy requirements, to develop sales business main body must be for the pharmaceutical retail chain enterprises, and must be a separate bid "Internet drug trading services qualification certificate"."Detailed rules" follows the principles of consistent "online", reduce the barriers to entry, the access to justice, regulations, medical device manufacturing enterprise as long as meet the requirements of the offline medical equipment sales can be used to fulfill its obligations to conduct online sales network for the record.
At the same time, the detailed rules also simplify the process of handling affairs. It is clear that the proposed filing enterprise only needs to submit the application materials to the accepting department, which will conduct formal examination.Require companies to strengthen quality management of medical apparatus and instruments, further clarify quality management agencies, through the establishment of effective quality management system, improve their own quality risk control ability, ensure the quality and safety of medical equipment.Clear for the enterprise has been put on record, regulators in filing within three months from the date of on-site inspection, and develop the detailed on-site inspection, solve between the upper and lower levels, the different jurisdiction standards are inconsistent, do not form a complete set, no problem.