Medical network May 22 - May 4, 2017, premier li keqiang signed a state council order no. 680, published "state council on modifying the < regulations on the supervision and administration of medical devices > decision", and come into force from the date of release.
This means that after two years of revision, the regulations on the supervision and regulation of medical devices have changed greatly since this month. And because this is existing for medical devices industry the highest level, which is the most important rules, its content changes will deeply affect the regulation of the industry in the future work.
On May 6, 2015, the state council examined and passed at the 91th executive meeting of the clean-up opinions put forward non-executive licensing examination and approval items, will be a large medical equipment configuration by non-executive approval is adjusted for examination and approval matters in the administrative licensing items, further standardize and strengthen the management of large medical equipment configuration, use.
In July 2015, the national health development planning commission in consultation with the administration of drug safety determine revision ideas, with the defender planning commission draw consensus drafted the amendments to the "regulations on the supervision and administration of medical devices (SongShenGao)" (hereinafter referred to as the "SongShenGao"), and the state council for examination.
On May 4, 2016, the legislative affairs office of the state council asked for comments on the draft.
On May 4, 2017, the revised regulations on the supervision and administration of medical devices was officially announced and implemented.
It is worth noting that last comment "SongShenGao" is put forward to the revised content also is associated with large medical equipment allocation and use, and eventually published revisions, but increased the relevant medical device clinical trials, content of the revision of the incoming inspection, etc. This suggests that the regulatory landscape has changed in the past year.
For large medical equipment, the revised regulations on the supervision and administration of medical devices are explicitly required to permit them. Hospitals will face heavy fines and other administrative penalties for unauthorized use of large equipment without permission.
The regulations on the supervision and administration of medical devices for the first time will be related to large medical equipment special provisions include, release the country to the medical equipment purchase and sale of real strong signal.
Secondly, the new regulations on the supervision and administration of medical devices in clinical trials made some revision content, clear the clinical test units a filing management, cancel the qualification. This, in the form of more specific rules, rules out the "upper position" barrier.
Once again, the new regulations on the supervision and administration of medical devices have put a great deal of good news for businesses and medical institutions in the industry.
Medical device industry regulations have some "persistent", including: do not conform to the prescribed standards, not registered according to law, expired, failure of medical apparatus and instruments abound.
Especially since YiXie management and use of regulation releasing, the agency's regulation by production extends to the management, use the link, the problem of medical devices were found, and so a large number of enterprise and use the unit by administrative penalty.
There is no lack of among them high fines and big cases, such as a hospital last year due to use not in accordance with the registered medical device was sent more than 1000 ten thousand yuan, an enterprise was sent more than 100 ten thousand yuan, an unlicensed medical devices at the same time to the number of medical institutions and so on.
The big case, the case of the case, the industry shock, and the business enterprise and the medical establishment to be confused: how to prevent such problems?
The revision has created a special provision for businesses and medical institutions that are exempt from fines.
And compare the measures for the management of medical equipment management and use, such as regulations on the supervision and administration of medical devices is still a "host law", "host law", thus on the one hand, clear the responsibilities between, on the other hand will also reduce the damage by mistake.
The following is a detailed revision of the new regulations on the supervision and administration of medical devices:
Article 18 is revised as: "in the clinical trials of medical equipment, shall be in accordance with the requirements for the quality control standard for clinical trials of medical apparatus and instruments, in the clinical test units have the corresponding condition, and clinical trials to forward the local people's governments of provinces, autonomous regions and municipalities directly under the food and drug supervision and administration department for the record. Clinical trials for the record of the food and drug supervision and administration department shall inform the clinical test units for the record the location of the food and drug supervision and administration departments at the same level and health departments of family planning.
"A filing management of medical device clinical trials. Medical instrument clinical trial institution shall meet the conditions and for the record management methods and quality control standard for clinical trials, by the food and drug supervision and administration department under the state council jointly with the departments of family planning of public health under the state council and promulgated."
Cypress blue instrument interpretation:
The change in the provision is to change the accreditation of the clinical trial institutions of medical devices to the record. This and are open for advice on the encourage pharmaceutical medical devices of clinical trial management innovation reform policy (draft) "the new rules, is the same.
It is imperative that the accreditation of clinical trial institutions be cancelled and changed to the record management.
2, paragraph 1 of article 34, the second paragraph, as the first paragraph: "medical apparatus and instruments and the using unit shall have to use medical device type, quantity and conditions appropriate to the storage places. Medical equipment use units shall strengthen the technical training of staff, according to the product specification, technical operation standard requires the use of medical equipment, etc."
Increase a, as the second paragraph: "use unit configuration of large medical equipment, medical devices shall comply with the family planning departments of health under the state council of the large medical equipment allocation planning, and its function orientation, clinical service requirements, with corresponding technical conditions, supporting facilities and have corresponding qualifications and ability of professional and technical personnel, and approved by the family planning departments of health under the people's government at or above the provincial level, large medical equipment allocation license."
Increase a, as the third paragraph: "measures for the management of large medical equipment allocation by family planning departments of public health under the state council jointly with the relevant departments under the state council. Large medical equipment directory by the department in charge of family planning of public health under the state council put forward the relevant departments of the state council, executed after the approval of the state council."
Cypress blue instrument interpretation:
The provisions of the provision of large medical equipment include the required statutory conditions, implementation departments, and the contents of the catalogue.
For the content, state development planning commission of the SongShenGao drafting explanation has made it clear that medical institutions are widespread bed size and large medical equipment expansion impulse, if you don't take effective measures, will exacerbate medical resources layout is not scientific, structure is not reasonable.
Countries need to large medical equipment allocation problem "the knife" indeed, prevent medical institutions "equipment", which is the first three types of equipment: "expensive and complex technology, high risk of large equipment put into use, many of which equipment technology is not mature, economical efficiency and low cost effect." These are also the names of the national health and family planning commission in the draft of the draft.
3, paragraph 1 of article 56, in the second paragraph to merge, as the first paragraph: "the food and drug supervision and administration department should strengthen the medical device manufacturing enterprise production and management, and use the unit of medical apparatus and instruments used random inspection. Inspection fee and any other fees may be charged on random inspection, the costs into the government budget at the corresponding level. The people's government at or above the provincial level the food and drug supervision and administration department shall, according to random inspection conclusion medical instrument quality announcement in a timely manner."
Increase a, as the second paragraph: "family planning departments for public health shall exercise supervision over the use of large medical equipment status and evaluation; found illegal use and associated with large medical equipment such as excessive examination, excessive treatment, should immediately correct, dealt with in accordance with the law."
Cypress blue instrument interpretation:
The provision of this provision shall be added to the provision of excessive examination and treatment in time. This is to control drug consumables income in the hospital at the same time, to prevent medical institutions income depends on the equipment check treatment, from "medicine for the medical" into "machinery repair cure".
Increase a 4, article sixty-three, as the third paragraph: "without the permission of use of large medical equipment configuration, by the family planning departments of health under the people's government at or above the county level shall be ordered to stop the use, given a warning and confiscate the illegal income; the illegal income of less than 10000 yuan, and be fined between RMB 10000 yuan and 10000 yuan; the illegal income of 10000 yuan of above, and be fined five times more than 10 times the illegal income; if the circumstances are serious, don't accept those responsible for five years and units of large medical equipment allocation licensing applications."
Cypress blue instrument interpretation:
The provision added "hospitals without permission to configure the use of large-scale medical equipment". In the future, there will be a huge penalty for such violations.
5, paragraph 1 of article sixty-four is revised as follows: "to provide false information or take other deception to obtain registration certificate of medical equipment, medical equipment production license, medical equipment business licenses, large medical equipment allocation license, advertising and other documents of approval certificates, revoked certificates which have been obtained by the original license issuing department, and be fined between RMB 50000 yuan and 50000 yuan, not to accept the relevant responsible persons and units within five years of medical equipment licensing applications."
Cypress blue instrument interpretation:
The provision adds to the administrative penalty for "obtaining a license for large medical devices".
Increase a 6, article sixty-six, as the second paragraph: "the medical equipment management enterprise, the use of units to fulfil the obligations such as the incoming inspection of these regulations, have sufficient evidence to prove that they don't know the management, use of medical apparatus and instruments for the first paragraph of the preceding paragraph, paragraph 3 cases of medical apparatus and instruments, and can truthfully explain the source of replenish onr's stock, may be exempted from punishment, but shall confiscate its management, use, do not conform to the legal requirements of medical devices."
Cypress blue instrument interpretation:
This clause increases the disclaimer of the operation of medical devices and the use of units.
Namely, trading enterprises and use the unit as long as the incoming inspection duty, and can be self knowledge, have been found to operate using do not conform to the compulsory standards or does not conform to the product technical requirements for registration or registration of medical devices, and another was found to use certificate for qualified products, expired, failure, obsolete, not registered in accordance with the law of medical apparatus and instruments, trading enterprises and use the unit won't be fined or even closure and revocation of licenses.
This new regulation to strengthen the business enterprise and unit using incoming inspection duties, also means that as long as serious to perform its obligations, of course, is no need to worry face 5 to 10 times the collapse of heavy fines.
Increase a 7, article sixty-eight, item 9 as: "(9) medical devices unit using illegal use of large medical equipment, cannot guarantee medical quality and safety", and change the original item 9 to 10 items.
Cypress blue instrument interpretation:
Have been added to the terms and conditions for hospital use punishment according to the content of large medical equipment, weight degree, according to the circumstances of the violation penalties from shall be ordered to correct, warning, and the fines of up to 5000-20000 yuan, to order the hospital license suspension and revocation of large-scale medical equipment configuration.
Eight, the article sixty-nine is revised as follows: "in violation of the provisions of these regulations to carry out medical device clinical trials, by the people's governments at or above the county level to the food and drug supervision and administration department shall be ordered to correct or stop clinical trials, to a fine of less than RMB 50000; thereby causing serious consequences, in accordance with the law, the person in charge directly responsible and other persons directly responsible for demoted, dismissed or expelled disposition; the agency may not conduct within five years relevant professional medical device clinical trials.
"Medical device clinical test units issued a false report, by the people's governments at or above the county level to the food and drug supervision and administration department shall be imposed a penalty fine not exceeding 50000 yuan and 100000 yuan; have the illegal income, confiscate the illegal income; the person in charge directly responsible and other directly responsible personnel, given sacked or kicked out of the sanctions according to law; the 10 years may not conduct relevant professional medical device clinical trials."
Cypress blue instrument interpretation:
The revision of this provision is also the qualification of the clinical trial organization of medical devices.
Nine, the article seventy-three is revised as follows: "the food and drug supervision and administration department, health department in charge of family planning and their personnel shall strictly in accordance with the provisions of these regulations, amplitude, and the types of the punishment according to the circumstances of the nature of the illegal act and the specific exercise of administrative punishment, the specific measures by the food and drug supervision and administration department under the state council, the department in charge of family planning according to their respective duties of public health."
Cypress blue instrument interpretation:
The provision of this provision gives the administrative penalty authority to the health and family planning department.
10 and article seventy-six increase: "large medical equipment, is refers to the use of the complex technology, large net inflow, high operation cost, large impact on the health care costs and included in the directory management of large medical equipment."
Cypress blue instrument interpretation:
This is included in the "annex", which is a description of the concept of a large medical device. |
