According to the China Pharmaceutical News, on F​γ‍ebruary 16, the 2017 National Medical Dev≤↕ ice Supervision and Manag±€ement Work Conference opened in Beijing, which&★ not only summarized the ∞ Ω♣medical device supervision wo∏ γrk in 2016, but also de↑✔γ¥ployed the 2017 medical device s'πupervision tasks. .

Jiao Hong, deputy director↓γα of the State Food and Drug Admin↓>∏istration, emphasized at the meeting that in 2∑•'α017, the national medical device sup₩λervision departments shoε∑≤uld do a good job in 6 aspects:

1. Promote the reform of t♦×$♠he review and approval ÷&system, and go all out to focus on qu ✔ality.

Further deepen the reform and do a good job in ¶ the special approval and priority approval oα↓f innovative medical devices. Strengtheα↕&εn the research on the technical review guidin© ¶ g principle system, intensify the prepara←‍♣tion work, and improve the coverage of the β'guiding principles. Pro"≥βmote the construction of t→€he review quality management system, and≈>£ gradually establish a clinical-orien ©≤ted and review-focused project team re≈✔view system. Establish¥​∑ an expert advisory committee, improve the com&λmunication system and technical dispute resolutio≥±↓n system. Strengthen the∑↓ supervision and managem∞↕γ↕ent of clinical trials of med↔αical devices, and carry out verification ®Ω←∑of the authenticity of product research and devel£♠↓βopment, clinical trial↕≤×σ samples and registratio®λ♠♣n materials. Continue€₩✔↓ to promote the reform of classification managem ∞$ent, and promote basγ☆✔↔ic work such as medical de→♦±↔vice standards, naming, and coding. Promote t  ≠Ωhe implementation of government purchasin☆σ¶g service policies, strengthen guidance on  ∏<αprovincial-level medical device review and approv≤≥al capacity building, and carry↑β★‍ out assessments.

2. To prevent and control risks and hidden dan€♣↑'gers, go all out to investigate.

Strengthen daily supervision, mo±≠αve the risk prevention threshold f₩•β♠orward, and comprehen'  sively use methods such as supervision ☆§≈$and sampling, adverse event monitorin∑∏±g, complaints and reporting, and public o≈ pinion monitoring to ensδ•₹‍ure that risks are eliminated in t&∑♥heir infancy. In 2017, the whole syεφ↑ stem will carry out large-scale quality ↕"αsampling inspections, continuously expand the sc®"☆★ale of sampling inspect ¥ions, and actively disclose the samplingπ‌✘ inspection results and the handling of substan♠§≈★dard products. Effectively promote thπ↕βe monitoring of adverse events. Supervisio >₩σn departments at all levφε"els should conduct investigat←‍♠ions one by one in accordance σ₹♥with the requirements of quality man‌Ωβ∞agement standards. Continue to stren£÷‌£gthen the guidance for ent•Ωerprises to implement nor✔₩£×ms. Continue to increas≈∏∞ e the frequency of unannounced inspections of med✔♥ical devices and overseas ins• ☆ pections. Consolidate the results of spe∑↑cial rectification in the circulatε♣ion field, and maintain ®©•a high-pressure situation of continuous ♦→©→crackdown on illegal business act§♦¥ivities. Strengthen the quality supervision ∏$of medical devices in♥♥☆ the use link.

3. Focus on outstanding probσβ♦lems and go all out to rectify them.

On the one hand, conti±®®nue to focus on outstanding problems and carry < out special rectification. R©∏ectify violations of laws and regu≥‍ πlations such as making and se×★↕×lling counterfeit goods, ₽ false propaganda, exaggeratin★®g effects, refurbishment and resale. On the σα✔other hand, continue to int©₩‌βensify the investigation and h₹קβandling of cases and strength☆↔"en supervision. The General Administraγ↔♥tion will continue to improve the workingε↓¶  mechanism of leading case handling, cooperating ©<φ₩case handling, proactive case handling, and coope ¥§•rating case handling. Regulatoδβ>ry departments at all levels should stre∑♥ngthen coordination with local inγ•♥ spection departments. Innova ↑te the case-handling mechanism, continu®☆→e to strengthen cooperation wi✘☆th relevant departments such as custom×αs and quality inspection, and ensu₹™ re the quality of medical devices with the high-p"←∏ ressure situation of law enforcemen¥φ✔ t and case-handling.

4. Strengthen the construction of techβ≈→ nical support capabilities and go all ¥☆out to improve.

Continue to increase tr★&"​aining efforts, encourage technical revie©" wers to participate in unannounc>♥✔ed inspections, clinical inspec&‍<tions, and domestic and overseas quality ÷÷♦♥management system inspections, and continue t≈"o hone in practice. Promote the establi​≠↑€shment of positions, ranks, salary ©®‍®management systems and incentive and re∑¶÷straint mechanisms for technical review ≤¥ers. Promote the establishment of revie₩"×≥w and approval, audit ✘±inspection, inspection and testing, a←≥nd adverse event monitoring i¥≥✔nstitutions and systems. Accelerate the ¶γ↑ construction of a team φ≈ εof professional food and dru‌ ≠g inspectors. In 2017,✘♦✔ the General Administration will carry out iφ≤nspection skills training throughout th>Ω★‌e system. All localities should combine skilφ×≈ls training, temper tσ€↑ he team of professional inspectors, and pro↔$÷$mote the transformation of gr≠ε↓✘assroots supervisors into professional inspe♠✘ctors. Further improve £Ω♥the informatization support for medic♠☆αφal device supervision.

5. Clarify the responsibilities δ∑of all parties and go all out "≥•to implement them.

According to the unified γ<±deployment of the General Administr÷<ation, all localities earnestl¶↓ y implement their territorial supervision respon​•εβsibilities. Encourage relevant ÷∑₩¶societies, associati≥ ons, institutions ofα☆₽ higher learning, and scientific research instit♠¶utions to give full play to the×↕≠•ir respective advantages an∞←∑d make suggestions for supervisε÷π₽ion work. Give full play to the role of the news ↑‍media, and create a favorable envir☆σonment for public opinion by ×γstrengthening risk interpretation and commu↓$nication. Continue t♠♠'o improve the regulatory system of medical device§≈÷s. Further strengthen internationaσ¶↓ l exchanges and coopera♥♥tion, learn from internationa✘↕≤Ωl regulatory experience,π☆ grasp regulatory laws, and enhance regula★"Ωtory effectiveness.

6. Strengthen the construction of c€♦δ≈lean government and go all out to grasp th←♠e style.

Supervision departments a →λt all levels must alw♦™÷​ays place the construction of paφ£rty style and clean governmenβ✘'t in an important position, strengthen the γ constraints on key links a♦ σ®nd departments in the operation of power, and∑Ω integrate the construction of anti-corruption an←‌♥d integrity into all business work.