The national pharmacy renovation begins!

Sorting out: Xiyu

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", in accordance with the deployment of the 2021 National Medical Device Supervision and Management Work Conference, in order 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 of hidden dangers of medical device quality and safety is carried out.

The "Notice" clarified that we must start from four aspects.

As for the inspection method, the "Notice" pointed out that it is necessary to actively innovate the inspection mode.

According to data from the National Food and Drug Administration, as of the end of 2019, there were 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.

Retail pharmacies, focusing on medical masks, condoms, etc.

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.

The first is epidemic prevention and control medical equipment.

The second is the online sales of medical devices.

The third is products and companies with frequent complaints and reports.

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 in accordance with the requirements, and form a ledger for the hidden risks found in the self-examination, and Formulate a rectification plan and take rectification measures in a timely manner to eliminate hidden risks.

The self-inspection form of hidden dangers of operating enterprises is as follows:

Illegal selling medical equipment, the most severe punishment is coming

In addition, it should be noted that the "Notice" also emphasizes the implementation of the "four most stringent" requirements.

The "Notice" also pointed out that, taking the implementation of the new "Regulations on the Supervision and Administration of Medical Devices" as an opportunity, strengthen the training of 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.

In accordance with 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 or more than 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 own 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 in accordance with 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 confiscated 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 in accordance with the technical requirements of the registered or filed product, or failing to establish a quality management system and maintain effective operation in accordance with 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 10,000 yuan up to 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 in accordance with 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 in accordance with 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 in accordance with the provisions of these regulations, fail to report adverse events in accordance with 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 in accordance with regulations and ensure their effective implementation;

(7) The medical device registrant and recorder fail to establish and implement a product traceability system in accordance with the 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 in accordance with 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 in accordance with 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.