Attention pharmacies that sell medical masks, condoms, and sticky medical devices, the nationwide inspection is coming.
590,000 medical equipment operating companies, the nationwide inspection is coming
On March 26, the Comprehensive Department of the State Food and Drug Administration issued the "Notice on Carrying out the Investigation and Treatment of Hidden Risks of Medical Device Quality and Safety" (hereinafter referred to as the "Notice").
According to the "Notice", under the deployment of the 2021 National Medical Device Supervision and Management Work Conference, to thoroughly implement the "four most stringent" requirements, strengthen medical device risk management, further improve the level of quality and safety assurance, and promote the high-quality development of my country's medical device industry, Now the investigation and management work is carried out on the hidden dangers of the quality and safety of medical devices.
The "Notice" clarified that we must start from four aspects. One is a comprehensive investigation of hidden dangers, and timely detection and elimination of signs and tendencies; the second is the full implementation of governance responsibilities, and the implementation of all responsibilities to people; the third is management The level has been comprehensively improved; the fourth is the comprehensive enhancement of quality assurance.
As for the inspection method, the "Notice" pointed out that it is necessary to actively innovate the inspection mode. Drug regulatory authorities at all levels can adopt various forms such as cross-inspection, joint inspection, entrusted inspection, and "Internet + supervision" to carry out investigation and governance and organize "look back" on key enterprises using follow-up inspection and third-party evaluation.
According to data from the National Food and Drug Administration, as of the end of 2019, there was 593,000 Class II and Class III medical device operating companies nationwide, of which 347,000 were only operating Class II medical device products, and only 6.9 were operating Class III medical device products. There are tens of thousands of companies operating at the same time as the second and third categories of medical device products. This also means that the next 590,000 medical equipment operating companies will face major inspections.
Retail pharmacies, focusing on medical masks, condoms, etc.
As we all know, retail pharmacies operate medical devices, especially Class II medical devices, involving thermometers, sphygmomanometers, blood glucose meters, electronic blood pressure, and pulse meters, ultraviolet therapy devices, infrared therapy devices, magnetic therapy stickers, ultrasound physiotherapy devices, and electronics. Acupuncture instrument, moxibustion instrument, electronic moxibustion therapy instrument, electric cupping device, pot therapy instrument, acupoint magnetic patch, medical absorbent cotton, medical absorbent gauze, medical cotton swab, medical mask, medical sterile gauze, wound dressing (breathable Application, waterproof application), sterile wound dressing, disposable wound dressing, emergency hemostatic bandage, scar repair patch, scar ointment, physiological seawater nasal cavity cleaning solution, medical eye protection patch, anti-snoring device, nasal ventilation patch, Blood glucose test strips, pregnancy diagnostic test strips (early pregnancy test strips), ovulation test strips, condoms, and many other products.
In other words, the nationwide inspection of medical equipment, that is, the pharmacies that handle these products must be inspected.
As for the focus of investigation and management, the "Notice" clarified 9 directions, including epidemic prevention and control medical devices, centralized procurement of selected products, online sales of medical devices, supervision and random inspection of unqualified companies, and products and companies that frequently complain and report. After combing, it is found that these three aspects have the greatest relevance to retail pharmacies.
The first is epidemic prevention and control medical equipment. The "Notice" requires that the focus is on the investigation of new coronavirus detection reagents, ventilators, medical protective clothing, medical masks, and infrared thermometers, etc., especially for emergency approval and commissioning, and cross-border conversion. Companies, as well as companies with unqualified product quality and defective quality systems.
The second is the online sales of medical devices. The "Notice" requires continuous "net clearance operations", focusing on the investigation of epidemic prevention and control medical devices, complaints and reports, and medical devices that are more focused on public opinion, as well as third-party platforms for medical device online transaction services. Statutory obligations. Focus on whether the product manual and label are consistent with the registered content; whether the product is sold following the scope of application and intended use of the registered product; whether there are behaviors such as asserting efficacy and false propaganda of the product when the product is sold. The drug regulatory authority supervises and inspects the third-party platform of medical device online transaction services no less than once a year, and supervises and inspects online sales companies no less than once every two years.
The third is products and companies with frequent complaints and reports. The "Notice" requires that focus on sodium hyaluronate for injection, contact lenses, orthokeratology, radiofrequency skin hyperthermia, radiofrequency ultrasound lipolysis instrument, facial radio frequency beauty instrument, Artificial nasal bridge implants, condoms, spinal orthoses, adolescent myopia correction eye and optic medical equipment, application medical equipment, as well as medical cold compresses sold under the name of "Machine Brand Mask", under the name of "Machine Brand Toothpaste" Conduct sales of cold compress gel, tooth desensitizer and other medical devices, comprehensively sort out complaints and reports, and carry out follow-up investigations when necessary for companies that have completed investigations and disposals to ensure that the investigation and disposal measures are in place; clues to problems that have not yet completed the investigation and disposal , Carry out investigations in a timely manner to ensure that the investigation is carried out to the end, and the hidden dangers of product quality and safety are effectively eliminated.
Pharmacies selling medical devices, all control, and self-examination
At the same time, the "Notice" requires that medical device manufacturers, operating companies (including online sales companies), users, and third-party platforms for online transaction services must conduct a comprehensive self-examination per the requirements, and form a ledger for the hidden risks found in the self-examination, and Formulate a rectification plan and take rectification measures promptly to eliminate hidden risks. The self-inspection form, rectification plan, and the implementation of rectification measures should be submitted to the local drug regulatory authority before June 30.
The self-inspection form of hidden dangers of operating enterprises is as follows:
Illegal selling medical equipment, the most severe punishment is coming
Also, it should be noted that the "Notice" also emphasizes the implementation of the "four most stringent" requirements. Seriously investigate and deal with violations of laws and regulations. If the self-examination is not in place, the rectification is not in place, and the main responsibility of the enterprise is not in place, the drug regulatory department will interview the legal representative of the enterprise, and the results of the interview will be announced to the public. Those who are found to be suspected of violations of laws and regulations shall be investigated and dealt with strictly following the law, and the requirements for punishment shall be implemented, and the connection of execution and discipline shall be strengthened.
The "Notice" also pointed out that, taking the implementation of the new "Regulations on the Supervision and Administration of Medical Devices" as an opportunity, we will increase the training efforts for enterprises, and use industry associations as bridges to organize enterprises to carry out exchanges and learning.
On the 18th of this month, the State Drug Administration’s official website officially announced the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations"), which stipulates the registration, filing, production, and operation of medical device products, and it is clear that from June 2021 It will be implemented on the 1st.
By the "Regulations," the state has established a professional and professional inspector system to strengthen the supervision and inspection of medical devices. Sorting out the "Regulations" legal responsibilities, the penalties for illegal operations of medical devices have been increased. Retail pharmacies must pay attention to these aspects.
Article 81: In any of the following circumstances, the department responsible for drug supervision and administration shall confiscate illegal income, medical devices used in illegal production and operation, and tools, equipment, raw materials, and other items used in illegal production and operation; medical treatment in illegal production and operation If the value of the equipment is less than 10,000 yuan, a fine of more than 50,000 yuan and less than 150,000 yuan shall be imposed; if the value of the device is more than 10,000 yuan, a fine of 15 times to 30 times the value of the goods shall be imposed; if the circumstances are serious, the production shall be suspended Suspension of business, no medical device license applications submitted by relevant responsible persons and units will be accepted within 10 years. Legal representatives, main responsible persons, directly responsible persons in charge, and other responsible persons of the illegal units shall be confiscated from the units obtained during the period of the illegal acts. Income, and a fine of more than 30% and less than 3 times of the income received, and prohibits them from engaging in medical device production and operation activities for life:
(1) Production and operation of Class II and Class III medical devices that have not obtained the medical device registration certificate;
(2) Engaging in the production of Class II and Class III medical devices without permission;
(3) Engaging in the third-class medical device business activities without permission.
In the case of the first item of the preceding paragraph and the circumstances are serious, the original license-issuing department shall revoke the medical device production license or medical device business license.
Article 83: Where false information is provided or other deceptive methods are used when applying for an administrative license for medical devices, the administrative license shall not be granted. If the administrative license has been obtained, the administrative license shall be revoked by the department that made the administrative license decision, and the illegal gains and illegal gains shall be confiscated. For medical devices used in production and operation, applications for medical device licenses submitted by relevant responsible persons and units will not be accepted within 10 years; medical devices used in illegal production and operation with a value of less than 10,000 yuan will be fined 50,000 yuan up to 150,000 yuan; If the value of the goods is more than 10,000 yuan, a fine of 15 times to 30 times the value of the goods shall be imposed; if the circumstances are serious, the production and business shall be suspended, and the legal representative, the main person in charge, the directly responsible person in charge and other Responsible personnel shall confiscate the income received from their unit during the period of the violation, and shall impose a fine of 30% or more but not more than 3 times the income, and they shall be prohibited from engaging in the production and operation of medical devices for life.
Anyone who forges, alters, sells, rents, or lends relevant medical device licenses shall be confiscated or revoked by the original license-issuing department, and the illegal gains shall be confiscated; if the illegal gains are less than 10,000 yuan, a fine of 50,000 yuan up to 100,000 yuan shall be imposed. ; If the illegal income is more than 10,000 yuan, a fine of 10 times or more and 20 times the illegal income shall be imposed; if the violation constitutes a violation of public security management, the public security organ shall impose public security management penalties per the law.
Article 84. Under any of the following circumstances, the department responsible for drug supervision and management shall announce the name of the unit and product to the public and order it to make corrections within a time limit; if the correction is not made within the time limit, the illegal income and medical devices produced and operated illegally shall be confiscated; illegal production If the value of the medical device is less than 10,000 yuan, a fine of more than 10,000 yuan and less than 50,000 yuan shall be imposed; if the value of the medical device is more than 10,000 yuan, a fine of 5 times to 20 times the value of the goods shall be imposed; the circumstances are serious , For the legal representative, main responsible person, directly responsible person in charge and other responsible personnel of the illegal unit, confiscate the income received from the unit during the period of the illegal act, and impose a fine of more than 30% and less than 2 times of the income, within 5 years It is forbidden to engage in medical device production and operation activities:
(1) Production and operation of Class I medical devices that have not been filed;
(2) Engaging in the production of Class I medical devices without filing;
(3) The operation of Class II medical devices shall be filed but not filed;
(4) The documents that have been filed do not meet the requirements.
Article 85. If false information is provided during filing, the department responsible for drug supervision and administration shall announce the name of the filing unit and product to the public, and confiscate illegal income and illegal production and operation of medical devices; the value of illegal production and operation of medical devices is insufficient If the value of the goods is more than 10,000 yuan, a fine of more than 20,000 yuan and less than 50,000 yuan shall be imposed; if the value of the goods is more than 10,000 yuan, a fine of more than 5 times and less than 20 times the value of the goods shall be imposed; The legal representative, the main person in charge, the directly responsible person in charge, and other responsible persons shall confiscate the income received from the unit during the period of the illegal act, and impose a fine of 30% or more and less than 3 times the income, and prohibit them from engaging in medical treatment for 10 years Equipment production and operation activities.
Article 86. In any of the following circumstances, the department responsible for drug supervision and administration shall order corrections and confiscate the medical devices used in illegal production and operation; if the value of the medical devices used in illegal production and operation is less than 10,000 yuan, they shall be punished concurrently A fine of not less than 20,000 yuan but not more than 50,000 yuan; if the value of the goods is more than 10,000 yuan, a fine of 5 times to 20 times the value of the goods shall be imposed; if the circumstances are serious, the production and business shall be suspended until the registration of the medical device is revoked by the original issuing authority The legal representative, the main person in charge, the directly responsible person in charge and other responsible personnel of the illegal unit shall confiscate the income obtained from the unit during the period of the illegal act, and shall be dealt with. A fine of more than 30% of the income received but less than 3 times, and prohibits them from engaging in the production and operation of medical devices for 10 years:
(1) The production, operation, and use of medical devices that do not meet mandatory standards or do not meet the technical requirements of registered or filed products;
(2) Failing to organize production under the technical requirements of the registered or filed product, or failing to establish a quality management system and maintain effective operation by the provisions of these Regulations, which affects the safety and effectiveness of the product;
(3) Operating or using medical devices that do not have conformity certification documents, expired, invalidated, or eliminated, or use medical devices that have not been registered according to law;
(4) The department in charge of drug supervision and management still refuses to recall after it is ordered by the department in charge of drug supervision and management, or the production, import, and operation of medical devices are still refused to be stopped after the department in charge of drug supervision and management orders to stop or suspend production, import, or operation;
(5) Entrusting an enterprise that does not meet the requirements of these regulations to produce medical devices, or failing to manage the production activities of the entrusted manufacturing enterprise;
(6) Import expired, expired, obsolete and other used medical devices.
Article 87. Medical device operating companies and user units have fulfilled the obligations of purchase inspection and other requirements stipulated in these Regulations, and have sufficient evidence to prove that they do not know the medical devices they operate and use are listed in the first paragraph of Article 81 of the Regulations. 1. Medical devices under the conditions specified in Paragraph 1 of Article 84, Paragraph 1 of Article 86, and Paragraph 3 of Article 86, and the source of the purchase can be truthfully stated, and those that do not meet the statutory requirements for operation and use shall be confiscated Medical devices can be exempted from administrative penalties.
Article 89: In any of the following circumstances, the department in charge of drug supervision and administration and the competent health department shall order corrections and give warnings according to their respective duties; if they refuse to make corrections, a fine of 10,000 yuan up to 100,000 yuan shall be imposed; circumstances In serious cases, it shall be ordered to suspend production and business until the original license-issuing department revokes the medical device registration certificate, medical device production license, and medical device business license. The legal representative, the main person in charge, the directly responsible person in charge, and others of the illegal entity The responsible person shall impose a fine of not less than 10,000 yuan but not more than 30,000 yuan:
(1) Failing to submit the quality management system self-inspection report as required;
(2) Purchase medical devices from suppliers who do not have legal qualifications;
(3) Medical device operating enterprises and user units fail to establish and implement the medical device purchase inspection record system following the provisions of these regulations;
(4) Operating enterprises engaged in the wholesale business of Type II and Type III medical devices and the retail business of Type III medical devices fail to establish and implement a sales record system per the provisions of these Regulations;
(5) Medical device registrants, record holders, production and operation enterprises, and user units fail to carry out medical device adverse event monitoring under the provisions of these Regulations, fail to report adverse events by requirements, or monitor technical institutions for medical device adverse events and are responsible for drug supervision and management Failing to cooperate in the investigation of adverse events carried out by the relevant departments and health authorities;
(6) Medical device registrants and recorders fail to formulate post-marketing research and risk control plans following regulations and ensure their effective implementation;
(7) Medical device registrants and recorders fail to establish and implement product traceability systems per regulations;
(8) Medical device registrants, recorders, and operating companies engaged in online sales of medical devices fail to notify the department responsible for drug supervision and administration by regulations;
(9) For medical devices that require regular inspection, inspection, calibration, maintenance, and maintenance, the medical device user fails to perform inspection, inspection, calibration, maintenance, and maintenance under the requirements of the product manual and records, analyze and evaluate in time to ensure medical treatment The equipment is in good condition;
(10) The medical device user failed to properly keep the original materials of the third-class medical device purchased.
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