China Releases Document on Local Representatives' obligations and bolsters Adverse Event Reporti


Draft on Local Representatives' Obligations

In order to ensure the safety and effectiveness of imported medical devices, NMPA has released a draft titled “Measures for the Supervision and Administration of Local Representatives for Imported Medical Devices”. The State Drug Administration will be responsible for guiding the supervision and management of local agents. The holder of the overseas medical device listing permit can set up a representative office or authorize a local agent to facilitate the importation of medical devices into the country.

The draft includes information on the conditions and obligations of local authorized agents, supervision and management of agents by provincial authorities in their respective administrative regions as well as the legal liabilities of the agents.

Some of the obligations of these agents are listed below:

  • Product Registration in compliance with the country’s regulation

  • Post Market Surveillance, i.e. Management of Adverse Events etc

  • Serves as the liaison between the Overseas License Holder and relevant authorities

For more information on the draft, check out the following link:

- Draft on imported medical device agents.

Adverse Events reporting process

The State Administration of Market Regulation (SAMR) and the National Health Commission of the People’s Republic of China (NHC) had recently reviewed and approved “The Measures for the Management and Re-evaluation of Adverse Events of Medical Devices”. This measure is expected to be implemented on January 1, 2019 which aims to strengthen the monitoring and re-evaluation of adverse events, as well as to ensure competence in the management of possible risks that are capable of threatening human lives.

The holder of the medical device marketing license is tasked at maintaining a monitoring system for medical device adverse events. The holder is also required to establish an information transmission process with their authorized agents for timely exchange of related information. The measure has listed several main obligations in which the holder has to fulfill:

  1. Well-established Quality Management System;

  2. Establishment of organizations and/or personnel to engage in adverse event monitoring;

  3. Collation of timely reports of adverse events;

  4. Conducting investigations, analysis and evaluation, risk control measures and releasing of relevant information within a certain time frame;

  5. Constant research and compilation of risk assessment reports;

  6. Proactively carrying out re-evaluation of medical devices;

  7. Cooperation with relevant authorities during investigations of adverse events.

Once an (Individual) adverse event is discovered or informed, the holder shall immediately investigate the cause and report the incident, whereby:

  • The cause of death shall be reported within 7 days. After which, an investigation, analysis and evaluation must be carried out within 30 days;

  • Serious injuries are to be reported within 20 days. After which, an investigation, analysis and evaluation must be carried out within 45 days;

  • Instances that result in the likelihood of serious injuries or death to be reported within 20 days. After which, an investigation, analysis and evaluation must be carried out within 45 days.

Once a (group) adverse event is discovered or informed, the holder shall immediately:

  • Report to the Provincial branch by telephone or fax within 12 hours;

  • Immediately suspend production, sale and any use of the medical device. Relevant devices must be recalled if necessary;

  • Commence investigation and self-inspection of the production quality management system, and report to the Provincial branch within 7 days.

The holder shall conduct continuous research on the safety of the medical devices listed, which includes summarizing and analyzing adverse event reports, as well as conducting risks and benefits assessment of the medical products. Risk control measures are to be compiled into a periodic risk assessment report after listing. The holder shall complete the periodic risk assessment report every subsequent (full) year starting from the date of approval, within 60 days of the effective date. The report shall be submitted to the monitoring agency related to the authoritative entity that carried out the registration, i.e. if the registration is carried out by the State Drug Administration, the report is to be submitted to the National monitoring agency.

If there are adverse events that threaten human health and lives, the holder shall take the following actions:

  1. Suspend production and sales of related products;

  2. Inform all relevant users to stop the use;

  3. Recall products if necessary;

  4. Issue risk information;

  5. Self-inspection of production quality management system and conduct any necessary rectifications;

  6. Modifications of IFUs, labels and operating manuals;

  7. Improve on the production and design of products;

  8. Carry-out re-evaluation of medical devices;

  9. Change registration or filing according to regulations;

  10. Other risk control measures to be taken.

In any of the following circumstances, the holder shall initiate a re-evaluation and take corresponding measures accordingly:

  • Development in scientific research related to the safety and effectiveness of the devices;

  • Adverse Events that show the defectiveness of current devices;

  • Requirements by the State Drug Administration.

If control measures are required, the re-evaluation report must be submitted within 15 days. If the re-evaluation results indicate a threat to human safety and lives and that no effective risk control measures is available, the holder shall apply for a cancellation of the registration certificate or product record.

The released measure has also highlighted legal liabilities of the holder as well as medical equipment enterprises to facilitate the efficiency of the adverse events reporting process.

For more information on the measure released, check out the following link:

- The Measures for the Management and Re-evaluation of Adverse Events of Medical Devices.

Contact us at info@arqon.com.


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