Chapter I General provisions article to strengthen the supervision and inspection of medicines and medical devices, safety risk prevention and control, according to the People's Republic of China pharmaceutical administration law of the People's Republic of China pharmaceutical administration law implementation regulations for the supervision and administration of medical devices Ordinance and other relevant laws and regulations, these measures are formulated.

Second flight inspection of medical devices in these measures refers to the food and Drug Administration for drug and medical device development, production, operation and use links not informed in advance of the inspection. Article III the State food and Drug Administration is responsible for organization and implementation of medical devices nationwide flight check.

Local food and drug supervision and administration of medical devices of the Department is responsible for organizing the implementation of the administrative flight inspection.

Article fourth flight inspection of medical devices should be followed according to the independent, objective and impartial, scientific disposition principle, on security risk management.

Article fifth units under inspection to the food and drug administration organization and implementation of medical devices flight inspection shall cooperate, shall not deny, evade, or obstacles.

Sixth food and drug supervision and management departments should be in accordance with open government information require the disclosure of examination results, significant or typical case, you can take news releases to the public.

Article seventh food and drug supervision and management departments and staff concerned should strictly abide by relevant laws and regulations, the Commissioner of discipline and work requirements, shall not be presented to the inspected unit requirements regardless of the check may not disclose related the circumstances of flight or informants for information and business secrets of the units inspected.

Second chapter started eighth article has following case one of of, food drug supervision management sector can carried out drug medical devices flight check: (a) complaints reported or other source of clues showed that may exists quality security risk of; (ii) test found exists quality security risk of; (three) drug bad reaction or medical devices bad event monitoring tips may exists quality security risk of; (four) on declared information authenticity has questions of; (five) suspected serious violation quality management specification requirements of;

(F) serious does not keep records of enterprises, and (VII) other circumstances that need to carry out unannounced inspections. Nineth flight inspection should be carried out to develop screening programmes, explicitly check the matter, time, personnel and methods.

Need not open the way for investigation and inspection scheme should be clear.

If necessary, the food and Drug Administration can be combined with public security organs and other relevant departments to carry out unannounced inspections. Article tenth of the food and Drug Administration sent inspection teams should be composed of 2 or more inspectors, an inspection team leader accountability system into practice.

Inspectors should be the food and drug administration law enforcement officials, shall obtain the inspectors qualified personnel or other officer authorized the checks made according to inspection needs, the food and Drug Administration can invite experts in related fields to check the work.

Participate in the inspection staff shall sign a statement of no conflict of interest and the Commission's undertaking; between are engaged in inspection activities and their personal interests could conflict or conflict, should be offered to withdraw.

11th Inspection Unit shall investigate and verify the inspected units implementing drug and medical device regulatory laws to the actual situation, in accordance with the inspection scheme clearly on-site inspections focus on, and according to the risk management plan risk analysis.

12th members of the inspection team shall not inform the units under inspection to check travel and examines the content after a specified collection points, the first time direct access to the site directly checked for issues that might exist; shall not be disclosed during the inspection of progress, found illegal clues and other related information. 13th superior implementation of unannounced inspections of food and drug administration organization, timely inform the examination unit local food and drug supervision and Administration Department.

Units under inspection staff of the food and drug supervision and management departments should assist in the inspection, assist in checking personnel should be subject to the inspection arrangements.

14th organizations conduct unannounced inspections of food and drug supervision and management departments should strengthen the unit chain of command, according to spot checks of feedback adjust the coping strategies and, if necessary, start the coordination mechanism, and can send personnel to the scene to coordinate and direct.

Third chapter 15th after an inspection team arrived to inspect the site, inspectors shall produce relevant documents and food and drug supervision and administration of the departments appointed to carry out supervision and inspection law enforcement documents communicated to the inspection requirements and the rights and obligations of the inspected unit.

16th inspected unit and related personnel should be in accordance with the inspection request in a timely manner, clear head of site, open places or regions, cooperate with inspections of related facilities and equipment, maintain the normal production and operation, providing solid, effective and complete documentation, records, notes, documents, electronic data and other related materials, answering inspection inquiry. 17th shall make a detailed record of the unit check the time, place, site, etc; the problems should be found by a written record, and according to collect or copy documents, shooting-related facilities and equipment and material objects and the scene, collecting physical and ask related personnel.

Asking records should include asking object names, jobs and the content of the conversation, and ask about page-by-page signature or fingerprint.

Records should be timely, accurate, complete, and objective reflect an on-site inspection.

Flight formation during the inspection records and related information collected according to law, the real, can be used as a basis for ascertaining the facts in administrative penalties. 18th must extract products and other material to carry out an inspection, sampling inspection in accordance with the relevant provisions of the unit sampling or notify the unit under inspection sampling local food and drug supervision and management departments in accordance with the regulations.

Samples should be taken from a qualified technical body for inspection or verification, sampling inspection fee, appraisal fee by organizations conduct unannounced inspections of food and drug supervision and management departments. After the 19th Inspection Unit considered that evidence may be destroyed or lost or difficult to obtain, as well as the compulsory administrative measures need to be taken, you can notify the examination unit local food and drug supervision and Administration Department.

Units inspected local food and drug supervision and Administration Department shall take evidence preservation or compulsory administrative measures.

20th article has following case one of of, inspection unit should immediately reported organization implementation flight check of food drug supervision management sector timely made decided: (a) need increased check power or extends check range of; (ii) need take products recalled or suspended development, and production, and sales, and using, risk control measures of; (three) need filed investigation of; (four) suspected crime need transferred police organ of; (five) other need report of matters.

Risk control measures need to be taken, the units under inspection shall, in accordance with the requirements of the food and Drug Administration to take corresponding measures.

21st field checked by the inspection unit under examination is required to determine, to identify verified the problem as a principle.

After organizing the implementation of unannounced inspections of food and Drug Administration approval, inspection unit inspection. At the end 22nd check, the inspection team shall be to inform the units under inspection to check relevant information.

Disagrees with the units under inspection, can be stated and to defend themselves, the inspection team shall truthfully record. 23rd after the check is complete, the inspection team shall write inspection reports.

Check the contents of the report include: inspection process, identify problems, the relevant evidence, inspection findings and treatment recommendations. 24th unit shall, within 5 business days after the check is complete, inspection reports, inspection records, relevant documentary evidence and other organizations conduct unannounced inspections of food and drug supervision and management departments.

If necessary, you can cc units inspected local food and drug supervision and Administration Department. The fourth chapter 25th, according to test results, the food and Drug Administration can legally take rectification, warning letters, interviews the unit under inspection, monitoring product recalls, withdraw or cancel the relevant certificate of qualification, as well as the suspension of the development, production, sales, use and other risk control measures.

After the Elimination of risk factors, and risk control measures should be relieved.

26th State food and Drug Administration implemented need case investigation of flight inspection found violations, State food and Drug Administration to investigate and penalize directly, or you can specify units inspected local food and drug supervision and Management Department investigated and dealt with.

Local food and drug supervision and management departments at all levels to implement the needed case investigation of flight inspection found violations, should in principle be directly investigated.

By lower food and drug supervision and management departments to investigate, organize implementation of unannounced inspections of food and drug supervision and management departments should track steering investigation.

The 27th flight check finds an unlawful act of a crime, by the food and drug supervision and management departments in charge of case investigation transferred to the public security organs, and copied to the Procuratorate at the same level.

28th food and drug supervision and Administration Department shall be entitled at any time to enter into the inspected unit development, production, distribution, use, and other places to check, the units under inspection shall not refuse, escape.

Was check units has following case one of of, considered refused to, and escape check: (a) delay, and limit, and refused to check personnel into was check places or regional of, or limit check time of; (ii) no due reason not provides or delay provides and check related of file, and records, and notes, and voucher, and electronic data, material of; (three) to claimed staff is not, and deliberately stop production business, way cheat, and misleading, and escape check of; (four) refused to or limit shooting, and copy, and sampling, forensics work of;

(E) other circumstances that do not match check.

Inspection Unit the unit under inspection rejection, avoid checks shall make a written record shall be ordered to correct and timely reporting on flight inspection organizations food and drug supervision and Management Department; has not corrected after the correction, cause unable to complete the inspection work, inspection findings determined that does not meet the quality specifications, or other requirements. 29th units inspected for violation of law shall be subject to administrative penalties, and reject, evade supervision or forge materials relating to evidence, destroy, conceal, by the food and drug supervision and administration in accordance with the People's Republic of China pharmaceutical administration law of the People's Republic of China pharmaceutical administration law implementing regulations relating to the supervision and administration of medical devices Ordinance stipulates heavier punishment.
30th article was check units has following case one of, constitute violation security management behavior of, by food drug supervision management sector business please police organ in accordance with People's Republic of China security management punishment method of provides for punishment: (a) hinder check personnel law implementation positions, or threat check personnel personal security of; (ii) forged, and variable made, and sale or using forged, and variable made of approval file, and certification finds certificate, of; (three) hidden, and transfer, and sold, and damaged food drug supervision management sector law seized, and

Seized property; (d) falsifying, concealing or destroying evidence or false testimony, impact of checks carried out in accordance with law.

31st superior food and drug supervision and Administration Department shall promptly inform the flight test results of its implementation units inspected local food and drug supervision and Administration Department.

Lower food and drug supervision and management departments should be organized and implemented in a timely manner to fly significant problems discovered in the inspection report in writing food and drug supervision and Management Department at a higher level, and will before the end of the year the annual flight inspection summary report to food and drug supervision and Management Department at a higher level.

32nd flight check found in the culture, universality or longstanding, prominent problems, superior food and drug supervision and management departments interviewed units inspected local food and drug supervision and Administration Department in charge or the local people's Government responsible.

Being interviewed by the food and drug supervision and management departments should timely corrective measures, and report the rectification.

33rd article food drug supervision management sector and the about staff has following case one of of, should public informed; on about staff according to cadres management permission give administrative sanctions and disciplinary, or proposed processing recommends; suspected crime of, law transfer judicial organ processing: (a) leaked flight check information of; (ii) leaked whistleblower information or was check units commercial secret of; (three) issued false check report or test report of; (four) interference, and delay check or refused to filed investigation of;

(E) violation of discipline of the ICAC and (f) other acts of abuse of authority or malfeasance.

Fifth chapter supplementary articles article 34th food and drug supervision and management departments at all levels of medical devices should be flight inspection requirements for sampling and related costs included in the annual budget, and in accordance with the needs to be covered in full. 35th article of the rules take effect on September 1, 2015.