The state ordered!

Medical News, April 1st.
On March 26th, the State Drug Administration issued the "Notice of the Comprehensive Department of the State Drug Administration on Carrying out the Inspection and Treatment of Medical Device Quality and Safety Risks" (hereinafter referred to as the "Notice").

 

start up! National Medical Device Supervision and Investigation Action

 

This investigation involves all medical device manufacturers and users, and local drug regulatory authorities at all levels are involved!

 

According to the "Notice", the investigation and management of hidden dangers in the quality and safety of medical devices is mainly divided into three stages, self-inspection and rectification, inspection and investigation, and summary and improvement.

 

Before June 30, all medical device-related companies need to submit the self-inspection form (see end of the article), rectification plan, and implementation of rectification measures to the local drug regulatory authority.

 

In addition, the "Notice" emphasizes that: on the basis of promoting the comprehensive self-inspection of medical device manufacturers and the comprehensive investigation by the regulatory authorities, focus on key products, key enterprises, and key links, and sort out the inspection risks one by one.

 

Not only that, the National Bureau will also organize a supervision team to supervise the investigation and governance work in various places in a timely manner.
If the self-inspection 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 ask the legal representative of the enterprise to be interviewed.
The results of the talks are announced to the public.
Those who are found to be suspected of violations of laws and regulations shall be investigated and dealt with strictly in accordance with the law, and the requirements for punishment shall be implemented, and the connection of execution and discipline shall be strengthened.

 

　　Nine major work priorities

 

　　Attention to all machinery companies

 

　　The first half of the year was basically concentrated in the enterprise self-inspection stage, and the local drug regulatory authorities will conduct investigations before December.
Therefore, please pay attention to all medical device related companies, check and conduct self-examination as soon as possible, and quickly standardize rectification!

 

　　The key tasks of this investigation and governance are mainly divided into the following nine aspects.

 

　　1.
Epidemic prevention and control medical equipment

 

　　Focus on the investigation of new coronavirus detection reagents, ventilators, medical protective clothing, medical masks, and infrared thermometers and other epidemic prevention and control medical equipment, especially companies that have been approved for production and cross-border conversion, as well as companies with unqualified product quality and defective quality systems .

 

　　2.
pharmnet.
com.
cn/news/yyzb/" target="_blank">Selected products in centralized pharmnet.
com.
cn/news/yyzb/" target="_blank">procurement

 

　　Focus on the products selected in the centralized procurement of coronary stents and other countries, and focus on investigating whether the manufacturer strictly controls the raw material review and supplier management, whether the production process, quality control and finished product release control are in place, whether the traceability system is sound, and whether the adverse events found Carry out investigation and evaluation in time; whether the selected product delivery unit strictly follows the product manual or labeling requirements for transportation and storage, and keeps corresponding records; whether the medical institution conducts quality management such as the procurement, acceptance and storage of the selected product in accordance with the regulations.

 

　　3.
Sterile and implantable medical devices

 

　　Organize a comprehensive risk investigation for sterile and implantable medical device companies, focusing on artificial joints, intraocular lenses, balloon dilatation catheters, defibrillators, occluders, orthopedic materials, staplers and other high-value medical consumables, as well as disposables Use a sterile syringe.

 

　　Focus on investigating whether the raw material procurement and supplier management of the production enterprise meet the requirements, whether the key processes and special processes are identified and effectively controlled, whether the clean room (area) control meets the requirements, whether the process inspection, finished product inspection and finished product release are strictly implemented It is required that the drug regulatory department inspects the entire project of sterile and implantable medical device manufacturers at least once a year; whether the operating company is engaged in the operation (online sales) of medical devices without permission (for the record), and whether the operation (online sales) is not Medical devices that have obtained registration certificates or filing vouchers; whether the user purchases medical devices from suppliers without legal qualifications, whether they purchase or use medical devices that have not been registered, have no qualification certificates, expired, expired, or are obsolete.

 

　　The drug regulatory department shall supervise and inspect aseptic and implantable enterprises and users every year not less than 15% of the total number of relevant enterprises and units in the administrative area.

 

　　4.
Online sales of medical equipment

 

　　Continue to carry out the "Net Cleanup Action", focusing on the investigation of medical devices for epidemic prevention and control, medical devices that are more focused on complaints and reports, and public opinion, as well as the fulfillment of statutory obligations by third-party platforms for medical device online transaction services.

 

　　Focus on whether the product manual and label are consistent with the registered content; whether the product is sold in accordance with 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.

 

　　Five, supervise the unqualified enterprises in random inspections

 

　　Focus on the investigation of unqualified enterprises of the same variety and multiple varieties of unqualified enterprises for many years.
Make full use of medical device quality supervision and random inspection methods to find medical device manufacturers that may have potential risks and products that need to be focused on, such as infusion pumps, disposable nasal oxygen tubes, nerve and muscle stimulators and other products.
In-depth analysis of historical sampling data, digging out potential risks, and urging enterprises to make rectifications in place.

 

　　6.
Adverse event monitoring reminds companies that may be at risk

 

　　Focus on the investigation of adverse events The monitoring of manufacturers and medical device products that may have serious problems is focused on checking whether the company's quality management system is operating effectively, checking and confirming whether the product has hidden quality and safety risks, and urging the company to take targeted risk control measures.

 

　　7.
Products and companies with frequent complaints and reports

 

　　Focusing sodium hyaluronate for injection, contact lenses, orthokeratology lens, radio frequency skin hyperthermia, radio frequency ultrasonic fat dissolving instrument, facial radio frequency beauty instrument, artificial nose implant, condom, spinal orthosis, adolescent myopia correction eye Optometry medical devices, sticking medical devices, as well as medical cold compresses sold under the name of "Machine Brand Mask", cold compress gels sold under the name of "Machine Brand Toothpaste", tooth desensitizers and other medical devices, comprehensively sorted out For complaints and reports, if necessary, follow-up investigations will be carried out for companies that have completed investigations and disposals to ensure that the investigation and disposal measures are in place; for clues of problems that have not yet been investigated and handled, timely investigations will be carried out to ensure that they are thoroughly investigated and verified, and products are effectively excluded Hidden dangers of quality and safety.

 

　　8.
Innovative medical devices and related enterprises with conditional approval

 

　　The National Bureau promptly notified the list of relevant enterprises, and the provincial drug regulatory authorities focused on the investigation of relevant enterprise quality management system self-inspection, raw material procurement, production process control, finished product inspection and adverse event monitoring system operation, especially innovative medical devices and product innovation points Whether the relevant production process has been effectively controlled, and whether the conditions attached to the conditional approval product have been effectively implemented.

 

　　9.
Entrusted production by the registrant of the medical device

 

　　The investigation focused on whether the registration of medical devices to establish a sound quality management system, whether the security guarantees the quality of the life cycle of medical devices the ability to effectively carry out self-examination whether the quality management system, whether entrusted with the production company had strict quality management.

 

　　Recently, the State Drug Administration issued the revised "Regulations on the Supervision and Administration of Medical Devices," and the new "Regulations" will be officially implemented on June 1, 2021.

 

　　Undoubtedly, the implementation of the new regulations will inevitably have a huge impact on the medical device industry.
At this time, the country has launched a nationwide investigation and management of medical device quality and safety risks.
The purpose is self-explanatory, but I don’t know how many more this year.
Is the enterprise caught in the investigation storm? let us wait and see!

　　Medical News, April 1st.
On March 26th, the State Drug Administration issued the "Notice of the Comprehensive Department of the State Drug Administration on Carrying out the Inspection and Treatment of Medical Device Quality and Safety Risks" (hereinafter referred to as the "Notice").

 

　　start up! National Medical Device Supervision and Investigation Action

 

　　This investigation involves all medical device manufacturers and users, and local drug regulatory authorities at all levels are involved!

 

　　According to the "Notice", the investigation and management of hidden dangers in the quality and safety of medical devices is mainly divided into three stages, self-inspection and rectification, inspection and investigation, and summary and improvement.

 

　　Before June 30, all medical device-related companies need to submit the self-inspection form (see end of the article), rectification plan, and implementation of rectification measures to the local drug regulatory authority.

 

　　In addition, the "Notice" emphasizes that: on the basis of promoting the comprehensive self-inspection of medical device manufacturers and the comprehensive investigation by the regulatory authorities, focus on key products, key enterprises, and key links, and sort out the inspection risks one by one.

 

　　Not only that, the National Bureau will also organize a supervision team to supervise the investigation and governance work in various places in a timely manner.
If the self-inspection 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 ask the legal representative of the enterprise to be interviewed.
The results of the talks are announced to the public.
Those who are found to be suspected of violations of laws and regulations shall be investigated and dealt with strictly in accordance with the law, and the requirements for punishment shall be implemented, and the connection of execution and discipline shall be strengthened.

 

　　Nine major work priorities

 

　　Attention to all machinery companies

 

　　The first half of the year was basically concentrated in the enterprise self-inspection stage, and the local drug regulatory authorities will conduct investigations before December.
Therefore, please pay attention to all medical device related companies, check and conduct self-examination as soon as possible, and quickly standardize rectification!

 

　　The key tasks of this investigation and governance are mainly divided into the following nine aspects.

 

　　1.
Epidemic prevention and control medical equipment

 

　　Focus on the investigation of new coronavirus detection reagents, ventilators, medical protective clothing, medical masks, and infrared thermometers and other epidemic prevention and control medical equipment, especially companies that have been approved for production and cross-border conversion, as well as companies with unqualified product quality and defective quality systems .

 

　　2.
pharmnet.
com.
cn/news/yyzb/" target="_blank">Selected products in centralized pharmnet.
com.
cn/news/yyzb/" target="_blank">procurement

 

　　Focus on the products selected in the centralized procurement of coronary stents and other countries, and focus on investigating whether the manufacturer strictly controls the raw material review and supplier management, whether the production process, quality control and finished product release control are in place, whether the traceability system is sound, and whether the adverse events found Carry out investigation and evaluation in time; whether the selected product delivery unit strictly follows the product manual or labeling requirements for transportation and storage, and keeps corresponding records; whether the medical institution conducts quality management such as the procurement, acceptance and storage of the selected product in accordance with the regulations.

 

　　3.
Sterile and implantable medical devices

 

　　Organize a comprehensive risk investigation for sterile and implantable medical device companies, focusing on artificial joints, intraocular lenses, balloon dilatation catheters, defibrillators, occluders, orthopedic materials, staplers and other high-value medical consumables, as well as disposables Use a sterile syringe.

 

　　Focus on investigating whether the raw material procurement and supplier management of the production enterprise meet the requirements, whether the key processes and special processes are identified and effectively controlled, whether the clean room (area) control meets the requirements, whether the process inspection, finished product inspection and finished product release are strictly implemented It is required that the drug regulatory department inspects the entire project of sterile and implantable medical device manufacturers at least once a year; whether the operating company is engaged in the operation (online sales) of medical devices without permission (for the record), and whether the operation (online sales) is not Medical devices that have obtained registration certificates or filing vouchers; whether the user purchases medical devices from suppliers without legal qualifications, whether they purchase or use medical devices that have not been registered, have no qualification certificates, expired, expired, or are obsolete.

 

　　The drug regulatory department shall supervise and inspect aseptic and implantable enterprises and users every year not less than 15% of the total number of relevant enterprises and units in the administrative area.

 

　　4.
Online sales of medical equipment

 

　　Continue to carry out the "Net Cleanup Action", focusing on the investigation of medical devices for epidemic prevention and control, medical devices that are more focused on complaints and reports, and public opinion, as well as the fulfillment of statutory obligations by third-party platforms for medical device online transaction services.

 

　　Focus on whether the product manual and label are consistent with the registered content; whether the product is sold in accordance with 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.

 

　　Five, supervise the unqualified enterprises in random inspections

 

　　Focus on the investigation of unqualified enterprises of the same variety and multiple varieties of unqualified enterprises for many years.
Make full use of medical device quality supervision and random inspection methods to find medical device manufacturers that may have potential risks and products that need to be focused on, such as infusion pumps, disposable nasal oxygen tubes, nerve and muscle stimulators and other products.
In-depth analysis of historical sampling data, digging out potential risks, and urging enterprises to make rectifications in place.

 

　　6.
Adverse event monitoring reminds companies that may be at risk

 

　　Focus on the investigation of adverse events The monitoring of manufacturers and medical device products that may have serious problems is focused on checking whether the company's quality management system is operating effectively, checking and confirming whether the product has hidden quality and safety risks, and urging the company to take targeted risk control measures.

 

　　7.
Products and companies with frequent complaints and reports

 

　　Focusing sodium hyaluronate for injection, contact lenses, orthokeratology lens, radio frequency skin hyperthermia, radio frequency ultrasonic fat dissolving instrument, facial radio frequency beauty instrument, artificial nose implant, condom, spinal orthosis, adolescent myopia correction eye Optometry medical devices, sticking medical devices, as well as medical cold compresses sold under the name of "Machine Brand Mask", cold compress gels sold under the name of "Machine Brand Toothpaste", tooth desensitizers and other medical devices, comprehensively sorted out For complaints and reports, if necessary, follow-up investigations will be carried out for companies that have completed investigations and disposals to ensure that the investigation and disposal measures are in place; for clues of problems that have not yet been investigated and handled, timely investigations will be carried out to ensure that they are thoroughly investigated and verified, and products are effectively excluded Hidden dangers of quality and safety.

 

　　8.
Innovative medical devices and related enterprises with conditional approval

 

　　The National Bureau promptly notified the list of relevant enterprises, and the provincial drug regulatory authorities focused on the investigation of relevant enterprise quality management system self-inspection, raw material procurement, production process control, finished product inspection and adverse event monitoring system operation, especially innovative medical devices and product innovation points Whether the relevant production process has been effectively controlled, and whether the conditions attached to the conditional approval product have been effectively implemented.

 

　　9.
Entrusted production by the registrant of the medical device

 

　　The investigation focused on whether the registration of medical devices to establish a sound quality management system, whether the security guarantees the quality of the life cycle of medical devices the ability to effectively carry out self-examination whether the quality management system, whether entrusted with the production company had strict quality management.

 

　　Recently, the State Drug Administration issued the revised "Regulations on the Supervision and Administration of Medical Devices," and the new "Regulations" will be officially implemented on June 1, 2021.

 

　　Undoubtedly, the implementation of the new regulations will inevitably have a huge impact on the medical device industry.
At this time, the country has launched a nationwide investigation and management of medical device quality and safety risks.
The purpose is self-explanatory, but I don’t know how many more this year.
Is the enterprise caught in the investigation storm? let us wait and see!