Free experience way to engage in medical equipment business activities regulatory measures (for trial implementation)
In order to further standardize the free experience way to engage in medical equipment business activities, to protect the reasonable and safe use of medical equipment, and to crack down on false propaganda and illegal business practices, according to the "Chinese People's *** and the State of the Anti-Unfair Competition Law", "Chinese People's *** and the State of the Advertisement Law", "Medical Devices Supervision and Administration Regulations" (the Regulations of the supervision and administration of medical devices). Regulations for the Supervision and Administration of Medical Devices" (referred to as "Regulations"), "supervision and management of medical device business" (referred to as "Measures") and "medical device business quality management standard" (referred to as "medical device GSP") and other provisions, combined with the supervision and management of the actual, has formulated the "free experience to engage in the supervision and management of medical device business activities (for trial implementation)".
I. Grasp the business conditions
1. Regulations, engaged in medical device business activities, there should be with the scale and scope of operation of the business premises and storage conditions. According to the relevant provisions, the experience of the premises as a business enterprise on the products it operates in the implementation of advertising, marketing and trial behavior, should be regarded as the business premises of the enterprise. Including the claim that "only set up experience places for medical device experience, no actual sales behavior", should be regarded as part of the business process, should apply for a separate medical device business license or record. Business premises and warehouses shall not be located in the housing planning use for "residential" premises, shall not be located in the premises without fire inspection, shall not be located in the military management area, party and government organs, organizations, institutions and village (neighborhood) committee office area, shall not be located in various types of colleges and universities, and other unsuitable for the business premises.
2. Business premises and storage area. Business enterprises to submit an application for a medical device license (for the record) information, should be in the business premises in the schematic diagram of the clear experience of the premises and storage area and area (in terms of building ownership certificate of the floor area, the same below).
3. Business scope. Operating third-class medical equipment business, its "business license" and "medical equipment business license" on the business scope should be marked "three physical therapy and rehabilitation equipment (or medical ultrasound instruments and related equipment, medical high-frequency instrumentation and equipment) sales (excluding the diagnosis and treatment of disease, consulting services)"; the operation of the second class of medical devices Enterprises, its "Business License" and "Class II Medical Devices Business Record Certificate" on the scope of business should be marked "Class II Medical Devices (including Class II Physical Therapy and Rehabilitation Equipment sales, but does not include the diagnosis and treatment of disease, consulting services)".
4. Equipped with a computerized management system. Computer management system should be in line with the "medical device GSP" requirements, at the same time, enterprises should be equipped with monitoring equipment, business premises, experience places and warehouses to implement the dead-end monitoring, the use of external storage media to monitor the information on a monthly basis to back up, back up at least to save to the date of the back up after 4 months.
5. Equipped with professionals. Operating companies should be equipped with at least 1 physician or nurse practitioner or more professional and technical personnel, and on duty. In principle, according to 1 person / 30m2 equipped with professional and technical personnel, less than 30m2 or more than part of less than 30m2, are calculated in 30m2.
6. Standardize the setup of the warehouse. Cross-administrative areas set up warehouses, should be in the location of the enterprise regulatory department for medical equipment license (for the record) on the basis of change, and then to the warehouse where the county-level regulatory departments for the record.
Second, strengthen advertising supervision
7. Verification of medical device advertising approval documents. Should verify whether the medical device advertisements released by the enterprise has obtained the approval number of medical device advertisements, shall not be released without obtaining the approval documents, the authenticity of the approval documents have not been verified or the advertisement content is inconsistent with the approval documents of the medical device advertisements.
8. Filing of advertising approval documents. Enterprises should submit the relevant advertising approval information to the local county-level regulatory departments for the record.
9. Advertising content set. Business premises should be posted in a conspicuous position at least two times more than the enlargement of the "Medical Device License" (business record certificate), "Medical Device Product Registration Certificate", "Medical Device Registration Form" and other copies of the text. Shall not be posted, hanging letters of thanks, banners, Chinese medicine teaching wall charts. Recommended to individuals for personal use of medical device advertisements, should be prominently displayed "please read the product instructions or under the guidance of medical personnel to purchase and use. Medical device product registration documents have contraindicated content, precautions, advertising should be significantly marked "contraindicated content or precautions see instructions.
Three, to strengthen the daily supervision
10.on-site verification. Application for business license, in accordance with the "Medical Device GSP" and the requirements of this guidance to carry out on-site verification, does not meet the conditions, not licensed. Apply for the record, should be in accordance with the "Medical Devices GSP" and the requirements of this approach to the site for verification, meet the conditions to be filed; filed within one month from the date of its on-site verification.
11. Strict on-site supervision. At least once a year to arrange a full program inspection, increase the frequency of other forms of daily supervision (flight inspection, daily inspection, supervision and sampling and tracking inspection). On-site inspection should focus on the enterprise equipped with computer management system and backup whether in line with the requirements of this approach; enterprises in accordance with the provisions of Article 36 of the Regulations, the use of medical devices in accordance with the requirements of the manual, regular inspection, calibration, calibration, maintenance, repair and maintenance and to be recorded in a timely manner to analyze, assess, and to ensure that the medical device is in good condition.
12. Establishment of sales records. Enterprises should be invoiced at the same time to the consumer sales vouchers stamped with the seal of the enterprise, sales vouchers should be recorded at least the name of the medical device, specifications (model), the name of the manufacturer, quantity, unit price, amount, operating company name, business address, contact phone number, the date of sale in order to carry out the quality of traceability. Enterprises retain their own sales vouchers retention period with reference to the "Medical Device GSP" in Article IX of the purchase inspection records and sales records.
Four, create *** governance environment
13. Establishment of collaborative *** governance mechanism. As the process of experience of medical devices at the same time inevitably involves the use of medical devices, in accordance with the "Regulations" Article 39 requirements, the enterprise for medical equipment business license (for the record) within seven working days, the regulatory authorities should be the name of the enterprise, the address, experience the name of the medical devices used at the same time copy the enterprise's location of the health sector; in order to form the masses of safe and rational consumption of medical equipment awareness, and gradually form the Group prevention and control, to create a social **** governance atmosphere, the regulatory authorities should also be the business of the above information in the license (for the record) within 7 working days after the town of the enterprise location of the Office of Comprehensive Governance copied. Suspected of "free physical therapy", "diagnosis and treatment", timely transfer to the health sector to investigate and deal with.
14. Strengthen the comprehensive law enforcement efforts. The supervision process found in violation of the law, the comprehensive use of the "Anti-Unfair Competition Law", "Advertising Law", "Regulations", "Measures" and other laws and regulations, and intensify the crackdown.
15.Establishment of public exposure mechanism. Open up complaint channels to guide rational consumption. Issue consumer warnings to prevent the use of risk. Interaction with the public media, timely information on illegal business enterprises (product name, name of the manufacturer, business enterprise name, legal representative of the enterprise, the person in charge of the enterprise) and cases of exposure to enhance the deterrent effect; the seriousness of the case, the responsible person and the enterprise will not be admitted within five years of the application for a medical device business license (for the record).