According to the China Pharmaceutical News, on February 16, the 2017 National Medical Device Supervision and Management Work Conference opened in Beijing, which not only summarized the medical device supervision work in 2016, but also deployed the 2017 medical device supervision tasks. .

Jiao Hong, deputy director of the State Food and Drug Administration, emphasized at the meeting that in 2017, the national medical device supervision departments should do a good job in 6 aspects:

1. Promote the reform of the review and approval system, and go all out to focus on quality.

Further deepen the reform and do a good job in the special approval and priority approval of innovative medical devices. Strengthen the research on the technical review guiding principle system, intensify the preparation work, and improve the coverage of the guiding principles. Promote the construction of the review quality management system, and gradually establish a clinical-oriented and review-focused project team review system. Establish an expert advisory committee, improve the communication system and technical dispute resolution system. Strengthen the supervision and management of clinical trials of medical devices, and carry out verification of the authenticity of product research and development, clinical trial samples and registration materials. Continue to promote the reform of classification management, and promote basic work such as medical device standards, naming, and coding. Promote the implementation of government purchasing service policies, strengthen guidance on provincial-level medical device review and approval capacity building, and carry out assessments.

2. To prevent and control risks and hidden dangers, go all out to investigate.

Strengthen daily supervision, move the risk prevention threshold forward, and comprehensively use methods such as supervision and sampling, adverse event monitoring, complaints and reporting, and public opinion monitoring to ensure that risks are eliminated in their infancy. In 2017, the whole system will carry out large-scale quality sampling inspections, continuously expand the scale of sampling inspections, and actively disclose the sampling inspection results and the handling of substandard products. Effectively promote the monitoring of adverse events. Supervision departments at all levels should conduct investigations one by one in accordance with the requirements of quality management standards. Continue to strengthen the guidance for enterprises to implement norms. Continue to increase the frequency of unannounced inspections of medical devices and overseas inspections. Consolidate the results of special rectification in the circulation field, and maintain a high-pressure situation of continuous crackdown on illegal business activities. Strengthen the quality supervision of medical devices in the use link.

3. Focus on outstanding problems and go all out to rectify them.

On the one hand, continue to focus on outstanding problems and carry out special rectification. Rectify violations of laws and regulations such as making and selling counterfeit goods, false propaganda, exaggerating effects, refurbishment and resale. On the other hand, continue to intensify the investigation and handling of cases and strengthen supervision. The General Administration will continue to improve the working mechanism of leading case handling, cooperating case handling, proactive case handling, and cooperating case handling. Regulatory departments at all levels should strengthen coordination with local inspection departments. Innovate the case-handling mechanism, continue to strengthen cooperation with relevant departments such as customs and quality inspection, and ensure the quality of medical devices with the high-pressure situation of law enforcement and case-handling.

4. Strengthen the construction of technical support capabilities and go all out to improve.

Continue to increase training efforts, encourage technical reviewers to participate in unannounced inspections, clinical inspections, and domestic and overseas quality management system inspections, and continue to hone in practice. Promote the establishment of positions, ranks, salary management systems and incentive and restraint mechanisms for technical reviewers. Promote the establishment of review and approval, audit inspection, inspection and testing, and adverse event monitoring institutions and systems. Accelerate the construction of a team of professional food and drug inspectors. In 2017, the General Administration will carry out inspection skills training throughout the system. All localities should combine skills training, temper the team of professional inspectors, and promote the transformation of grassroots supervisors into professional inspectors. Further improve the informatization support for medical device supervision.

5. Clarify the responsibilities of all parties and go all out to implement them.

According to the unified deployment of the General Administration, all localities earnestly implement their territorial supervision responsibilities. Encourage relevant societies, associations, institutions of higher learning, and scientific research institutions to give full play to their respective advantages and make suggestions for supervision work. Give full play to the role of the news media, and create a favorable environment for public opinion by strengthening risk interpretation and communication. Continue to improve the regulatory system of medical devices. Further strengthen international exchanges and cooperation, learn from international regulatory experience, grasp regulatory laws, and enhance regulatory effectiveness.

6. Strengthen the construction of clean government and go all out to grasp the style.

Supervision departments at all levels must always place the construction of party style and clean government in an important position, strengthen the constraints on key links and departments in the operation of power, and integrate the construction of anti-corruption and integrity into all business work.