Drugs and then shot, sword refers to the medical treatment leave recall, a recall!

Pharmaceutical Network January 18 last year, May 1 last year, "Medical Device Recall Management Measures" was officially implemented.This recall of the new regulations after the introduction of a significant change is that the industry's enterprises active and passive recall of more products, In particular, many domestic enterprises also joined the initiative to recall the team.

Medical equipment recall, sitting in a large number of foreign-funded enterprises in Shanghai, called the 'medical device recall the first province' has always been the release of the recall is the largest, management should be considered the most abundant.

The latest news is that a few days ago, the Shanghai Food and Drug Administration issued a public "Shanghai Medical Device Recall Management Work Code" (Trial).

Shanghai Drug Regulatory Agency to come up with this recall of the new regulations, the General Administration of Drug Control "Medical Device Recall Management Measures," further supplement norms, is a further landing documents, many of the content is not clearly defined in the national version of the provisions of writing from.

One of the highlights of this document is the explicit regulation of medical device recalls, in particular the first-level recall of product defects in recall sequences.

The paper proposed that Shanghai Municipality should conduct cross-departmental and inter-provincial coordinated supervision on the recall of medical devices.

A voluntary recall involving the Shanghai medical institutions, if the medical institutions did not cooperate in the timely recall, the City Food and Drug Administration will inform the Municipal Health Planning Commission .If the provinces and municipalities medical device companies or medical institutions did not cooperate with the recall The Shanghai Food and Drug Administration will report the information to the drug supervisor of other provinces and cities and report it to the State Administration of Drug Control.

The need to order a recall, the City Food and Drug Administration Medical Device Supervision Office should also take the initiative to inform the Audit Office, timely inspection.

The document also made it clear that Shanghai Drug Administration should strictly supervise and inspect the recall effect of the enterprises.

5 cases, the recall of enterprises to conduct on-site inspection:

1, a voluntary recall

2, ordered the recall

3, the recall of the product site destruction

4, the State Administration of Drug Control or Shanghai Food and Drug Administration supervision of the initiative to recall

5, other

The on-site inspection focused on whether the recall was conducted according to the recall plan, whether the products to be destroyed were all destroyed or returned to the original factories abroad, whether the operating enterprises and medical institutions cooperated with the recall, etc.

Site inspection found that the existence of mechanical enterprises in the recall process fraud, or other illegal activities, the Drug Administration will investigate and deal with according to law and order a recall.

In addition, the initiative to recall at a level, the document made a special mention, Shanghai Drug Administration to strengthen the audit report on the recall of information, if necessary, held expert analysis will be organized on-site inspection company, interview companies, carry out monitoring of adverse events, the implementation of supervision and inspection Wait.

This new document from Shanghai Food and Drug Administration clearly strengthened the supervision and inspection on the recall of machinery enterprises and the direct recall of 'false recalls' and other acts. It will not work.

Article 1 (Purpose Basis) In order to further regulate the supervision over the recall of medical devices in this Municipality, this system has been formulated in accordance with the Measures for the Administration of the Recall of Medical Devices under the "Regulations on the Supervision and Administration of Medical Devices" and in combination with the actual supervision in Shanghai.

Article 2 (Division of Responsibilities) The SFDA Medical Device Supervision Office is responsible for the voluntary recall supervision and management of the medical devices in this Municipality and is responsible for the release of information on the voluntary recall of medical devices. The EMDA regulates the production of medical devices involving voluntary recalls Operators, medical institutions to carry out supervision and inspection, evaluation of the initiative to recall the plan, the recall effect, is responsible for the city administrative region of the recall information and supervision and inspection problems found in the SFDA, and inform the city's Health Planning Commission and related Provincial food drug Supervisory Authority.

City Food and Drug Administration audit department in charge of the city medical instruments Ordered the recall of supervision and management work, is responsible for medical devices ordered the release of information recall, evaluation ordered the recall plan, the recall effect, the organization of the District Market Authority on the area involved in the order to recall the medical device production and management enterprise Medical institutions to implement supervision and inspection and investigation according to law.

The Municipal Food and Drug Administration Drug Administration Circulation Management Office cooperates with the Medical Device Regulatory Office to organize the supervision and inspection of the medical device companies involved in the voluntary recall in its jurisdiction.

District Market Authority in charge of the area under the jurisdiction of the first category of medical equipment for the record of the supervision and management of the recall, review the first category of medical equipment filed in the jurisdiction of the "medical equipment recall incident report form" to assess the recall plan, the recall effect to the city food SFDA reports information on the recall and release of the first type of medical devices and the completion of the recall, and is responsible for conducting reports on the inspection and handling of the recall of medical devices and medical institutions under their jurisdiction involving the recall of medical devices and medical institutions, and urging them to report the recall of products.

Municipal Food and Drug Administration Law Enforcement Corps with the Medical Device Regulatory Office and the Audit Office on the major recalls on-site supervision and law enforcement.

The Municipal Food and Drug Administration Information Center is responsible for uploading medical device recall information to the Municipal Food and Drug Administration's government affairs network and sending the recall information to the State Food and Drug Administration Information Center.

Shanghai Pharmaceuticals and Medical Devices Adverse reactions Monitoring Center is responsible for recalling medical device-related adverse event monitoring and risk assessment and other technical work, put forward regulatory recommendations.

Article III (Information Audit) The SFDA Medical Device Regulatory Office, the Inspection Office and the District Market Regulatory Authority shall review the "Report on the Recall of Medical Device Recalls", which are voluntarily recalled and ordered to recall according to their respective duties, and review the key enterprises Determine the recall level is reasonable, the recall of medical devices involved in the information is consistent with the medical device registration certificate information found "Medical Device Recall Incident Report" is not correct, it should promptly notify the enterprise changes.

Within 20 working days from the date of receiving the "Report on Recall of Medical Device Recalls" as modified by the enterprise, the audit will be completed.

The SFDA Medical Device Regulatory Office and the District Market Authority may evaluate the voluntary recall plan submitted by the manufacturer and believe that the measures taken by the manufacturer can not eliminate product defects or control the risk of the product, Grade, expand the scope of the recall, shorten the recall time or the product's handling methods and other more effective measures to deal with.

Article 4 (Information Release) The second and third level "medical equipment recall report form" information release should be in accordance with the procedures of Annex 1, through the manager audit (audit time limit of 10 working days), the person in charge review (review deadline 10 A working day) to be released (release form see Annex 2).

Order to recall the information after the audit by the Food and Drug Administration Audit Department to be released (release form see Annex 3) District Market Authority in accordance with Annex 1 procedures require the completion of the audit within 5 working days, in accordance with Annex 2 or 3 Type of information reported to the Food and Drug Administration, the Food and Drug Administration unified release of the recall information.

The Municipal Food and Drug Administration Information Center shall, within 3 working days from the date of receiving and reviewing the information on the recall and release of the recall, disclose relevant information on the bureau's government affairs website and promptly transmit the information center of the State Food and Drug Administration.

Municipal Food and Drug Administration Medical Device Regulatory Office at the end of each quarter with the City of Drugs and Medical Devices Adverse Reaction Monitoring Center summary of recall information and the implementation of corporate recalls, and the relevant recall information to assess, extract the relevant risks, the formation of a written report, Bureau leaders .

Article 5 (Supervision and Coordination) The relevant business divisions (departments) and district market supervisory bureaus of the Municipal Food and Drug Administration shall pay attention to the recall information of medical devices and strengthen the supervision of the related medical device production and operation enterprises and medical institutions based on the recall information.

The suspected illegal, or the need to order a recall, the FDA Food and Drug Administration Medical Device Supervision Office should be informed of the audit department, the Office of the audit should be promptly handled in accordance with the law.

A voluntary recall involving the city's medical institutions, the recall evaluation found that the city medical institutions did not follow Regulations Requires real-time recall with the FDA Food and Drug Administration Medical Device Supervision Office should inform the relevant information to the Municipal Health Planning Commission, business, please help do a good job of supervision and management.

Recall of the evaluation found that medical equipment companies or medical institutions in other provinces and cities failed to comply with the requirements of laws and regulations with the implementation of the recall, Food and Drug Administration Medical Device Regulatory Office should inform the relevant information under the jurisdiction of food and drug regulatory authorities in provinces and cities, Good supervision and management, and reported to the State Food and Drug Administration.

Article 6 (Supervision and Inspection) The Food and Drug Administration Medical Device Supervision Office shall review the report within 10 working days from the date of receiving the recall summary evaluation report submitted by the enterprise and evaluate the recall effect, if necessary, Medical Device Circulation Office or Inspection Office organize enterprises to conduct on-the-spot inspection by the Market Supervision Bureau, and organize a major recall event to conduct an on-the-spot inspection by the Municipal Food and Drug Administration Law Enforcement Corps that should the recall not yet eliminate defects or control the risk of the product, the recall shall be required in writing; Recall, it should be notified to the Audit Office, the Audit Office in accordance with the requirements of the law ordered the recall company, ordered the recall notice, see Annex 4.

To take the initiative to recall at the first level, the Food and Drug Administration Medical Device Supervision Office shall strengthen the examination of the recall report data, hold an expert analysis meeting if necessary, organize on-site inspections, interviews with enterprises, carry out monitoring of adverse events, conduct supervision and inspection, etc. Regulatory measures.

The district market supervision bureau shall examine the report within 10 working days from the date of receiving the recall summary evaluation report submitted by the first type of medical device production and record enterprises in the jurisdiction and evaluate the recall effect and if necessary, Inspection, the site inspection and recall effect assessment, within 5 working days from the date of adoption in accordance with the requirements of Annex 4 or 5 SFDA; that the recall has not yet eliminated defects or control the risk of the product should be required in writing The enterprise shall be recalled. If the enterprise fails to make a recall, it shall order the enterprise to recall according to law, and order the recall notice in Attachment 4.

The following circumstances District Market Authority shall conduct on-site supervision and inspection.

Field supervision and inspection focus: 1. Whether the enterprise carries out the relevant recall according to the recall plan; 2. Whether all the recalled products to be destroyed are destroyed or returned to the original factory outside China; 3. Whether the relevant operating enterprises and medical institutions cooperate with the manufacturing enterprises to carry out recall work ; 4. Other provisions of the inspection.

During the site supervision and inspection, enterprises found fraud, fraud or other illegal activities during the recall process. The District Market Authority shall investigate and punish the case according to law and order it to be recalled. The results of the investigation shall be promptly reported to the SFDA.

This specification has been released since the trial date.