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Active " medical devices monitors regulation " apply at rising on April 1, 2000, byelaw of basis of medical inspect branch began medical devices of nearly 10 years to execute the law, normative the development of medical devices, production, manage, use and supervise administrative action. But " medical devices monitors regulation " also highlight an a lot of problem and inadequacy in practice, production of a few medical devices, manage, the illegal behavior in using, cannot according to " medical devices monitors regulation " undertake investigating.
" standard of quality of product of People‘s Republic of China " (the following abbreviation " product quality standard " ) the important legislation that serves as pair of product quality to carry out supervisory management, specific provision is engaged in product production, sales compaign must be being abided by in our country churchyard " product quality standard " . But to medical inspect branch whether according to " product quality standard " undertake medical devices executes the law, many medical inspect execute the law to personnel is known and do not reach the designated position, some thinking " product quality standard " cannot apply at medical devices to execute the law, some thinking that carry out " product quality standard " the duty that is qualitative inspect branch and door of The Ministry of Commerce and Industry. The author thinks, inspect branch is in medicine to be carried out strictly carry out " medical devices monitors regulation " while, ought to execute the law in medical devices in apply adequately " product quality standard " relevant provision, make sure people uses instrument security.
One, " product quality standard " and " medical devices monitors regulation " the legal impact analysis between
" product quality standard " regulation " this law place says the product is to show the course is machined, make, the product that is used at the sale " , product of apparent medical devices besides need not at the sale besides, all ought to belong to " product quality standard " in the product category that sets. At the same time " product quality standard " stipulate construction project is only unwell clearly also with this law, quality of war industry product supervises administrative measure to be made separately by the State Council, central the Central Military Commission, reason " product quality standard " ought to product of applicable medical devices.
" product quality standard " thirteenth the first regulation " the industrial product that endangers security of human body health and person, belongings possibly, must accord with the national level that ensures safety of human body health and person, belongings, occupation standard; Did not establish national level, occupation standard, the requirement that must accord with safety of health of safeguard human body and person, belongings " , the 2nd regulation " prohibit the industrial product of the standard that production, sale does not accord with safety of health of safeguard human body and person, belongings and requirement. Specific government measure is set by the State Council " , product of medical devices involves human body health directly, be based on afore-mentioned regulations, " medical devices monitors regulation " the administrative regulations that releases as the State Council, the product of medical devices that to prohibiting production, sale does not accord with the level that ensures safety of human body health and person, belongings and requirement had specific provision. Of course, the industrial product that endangers security of human body health and person, belongings possibly besides product of medical devices, still nicotian, salt, pesticide waits a lot of product a moment, the State Council also made corresponding administrative regulations.
But " medical devices monitors regulation " in, do not have " standard of basis product quality, enact this ordinance " formulation, how ought to this understand? The author thinks, " medical devices monitors regulation " besides cover prohibit outside the relevant content of the product of medical devices of the standard that production, sale does not accord with safety of health of safeguard human body and person, belongings and requirement, the development that returns pair of medical devices, production, manage, use and supervised the respect such as management to make a large number of provisions, and " product quality standard " outside be being supervised except the quality that formulary product is produced and sells segment, still stipulated with much space the product is civil responsibility, reason " medical devices monitors regulation " in only one part content is a basis " product quality standard " the regulation is made.
From the point of analysis of legal layer class, " product quality standard " it is the legislation that countrywide person enacts greatly, " medical devices monitors regulation " it is the administrative regulations that the State Council makes, " product quality standard " ought to be " medical devices monitors regulation " go up an one of laws, but because " product quality standard " specific provision " prohibit the industrial product of the standard that production, sale does not accord with safety of health of safeguard human body and person, belongings and requirement. Specific government measure is set by the State Council " , afore-mentioned specific government measure that made clear regulation of the State Council actually are in applicable when precede over " product quality standard " , reason executes the law in medical devices in, should preferential and applicable " medical devices monitors regulation " , in " medical devices monitors regulation " when setting accordingly, ought to applicable " product quality standard " . That is to say, " product quality standard " the statutory requirement to product quality, it is the main demand of pair of product quality, and " medical devices monitors regulation " it is the quality requirement that serves as special product to medical devices, product of medical devices should be accorded with as medical devices not only " medical devices monitors regulation " special quality requirement of the regulation, also should accord with " product quality standard " the main demand to product quality.
2, applicable to product of medical devices " product quality standard " should carry out by medical inspect branch
" product quality standard " quality of product of whole nation of director of supervisory department of quality of product of the State Council of the 8th regulation supervises the work, quality of product of place of prefectural class above supervises a branch to be in charge of the product quality inside area of politics of one‘s own profession to supervise the work, but its make clear a regulation the 3rd times " law has a regulation additionally to the supervisory branch of product quality, according to is carried out about legal regulation " . Be like " Pharmaceutical Affairs Law " it is law, stipulate medical inspect branch is in charge of medicines and chemical reagents controlling administrative job, qualitative inspect branch is not supervisory branch of quality of medicines and chemical reagents. " medical devices monitors regulation " belong to administrative regulations, be not " product quality standard " the 8th the 3rd law that weighs in the paragraph, but the author thinks, " product quality standard " thirteenth the 2nd regulation " prohibit the industrial product of the standard that production, sale does not accord with safety of health of safeguard human body and person, belongings and requirement. Specific government measure is set by the State Council " , already accredit the State Council is being made include " medical devices monitors regulation " wait for the industrial product that involves human body health and person belongings, security specific government measure, reason " medical devices monitors regulation " branch of clear medicine inspect supervises management department as product of medical devices, with " product quality standard " the 8th the 3rd " law has a regulation additionally to the supervisory branch of product quality, according to is carried out about legal regulation " the regulation does not conflict.
On the other hand, serve as law " administration sanctions a method " and " administration allows a law " specific provision, the State Council can decide exercise of an executive authority is other the administrative punishment authority of the executive authority and administrative license authority, and administrative punishment and the most serious content that but carry out quality to supervise,administration praises, " medical devices monitors regulation " as administrative regulations of the State Council, before this byelaw was not carried out, the quality that pledges inspect branch is product of medical devices supervises a department, pledge by product of medical devices of exercise of medical inspect branch after byelaw is carried out the quantity supervises duty namely.
" product quality standard " the 70th administration punishment that stipulates this code is decided supervises a department by product quality exercise of industrial and commercial perhaps branch, but law, administrative regulations punishs the mechanism of authority to have a regulation additionally to exercise administration, according to is carried out about the regulation of law, administrative regulations. " medical devices monitors regulation " as administrative regulations of the State Council, its make clear branch of formulary medicine inspect the 4th times to be in charge of medical devices controlling government, supervisory management ought to cover the content such as administrative license and administrative punishment, the generator of product of medical devices, person that sell violates on purpose " product quality standard " of the regulation, should by basis of medical inspect branch " product quality standard " decision administration punishment.
3, product of medical devices is applicable " product quality standard " a certain number of case
1. sells product of unqualified medical devices. " medical devices monitors regulation " thirtieth does not accord with level of state of medical devices 7 times to production or the set of medical devices of occupation standard punish criterion, but in execute the law in practice, medical inspect branch more it is to managing link to discover through sampling observation medical devices does not accord with national level or occupation standard, to this " medical devices monitors regulation " punish without set criterion, its thirtieth also registers certificate 9 times without the product to managing merely, prove without qualification, expire, invalidation, fall into disuse set of medical devices punish criterion, but because examine unqualified do not be equal to prove at having qualification, and the behavior itself that sells unqualified medical devices has greater society to endanger a gender again, according to " medical devices monitors regulation " punish hard to this kind of illegal behavior. Below this kind of circumstance, medical inspect branch is adducible " product quality standard " the 49th " the sale does not accord with the product of the national level that ensures safety of human body health and person, belongings, occupation standard, instruct stop to sell, confiscate break the law, the product of the sale, be in goods of illegal sale product to be worth amount equivalence above 3 times the following amerce; Have illegal income, be in confiscate illegal earning " the regulation carries out administration to punish.
2. uses unqualified medical devices. " medical devices monitors regulation " the 42nd also stipulated medical establishment is used merely register certificate without the product, prove without qualification, expire, the legal responsibility of the invalidation, medical devices that fall into disuse, if be,in medical devices use link sampling observation discovers off quality of medical devices, also cannot cite afore-mentioned laws undertake condemnatory. And " product quality standard " the 62nd regulation, the operator that serves industry will " product quality standard " come the 49th times fiftieth the product that 2 regulations prohibit selling is used at managing a gender to serve, instruct disuse, the product that uses to know or ought to knowing place belongs to the product that this code prohibits selling surely, be worth amount according to the goods that violates use product, this law is opposite according to the punishment of the person that sell sets punishment. So, execute the law in medical devices in the process, medical establishment uses unqualified medical devices as medical treatment service industry, can handle according to afore-mentioned regulations. A few service type business that are not medical establishment property use unqualified medical devices to also can be handled according to afore-mentioned regulations like hairdressing orgnaization.
3. is right of the sell person of product of unqualified medical devices light, reduce punishment. The sampling observation of classics of medical devices that management enterprise of medical devices sells thinks truly unqualified, but the method cannot be checked and accept to identify its to be through convention when medical devices manages an enterprise to be checked and accept in replenish onr‘s stock unqualified, and purchase from lawful channel again, can according to " product quality standard " fiftieth 5 regulation perhaps reduces punishment lightly.
4. party rejects to accept quality of product of medical devices to supervise an examination. " medical devices monitors regulation " branch of inspect of medicine of the 29th regulation sets supervisor of medical devices to produce enterprise, management enterprise and medical establishment to undertake supervisory checking to medical devices, but check to rejecting to supervise about the unit not set law responsibility. Basis of branch of inspect of drug of this kind of case " product quality standard " fiftieth give party 6 times the warning, instruct correct; Refus does not correct, instruct close down to rectify; The clue is particularly serious, move send gantry crane of The Ministry of Commerce and Industry to sell business license.
5. is confiscated use technically at production to not have register card tool of the Yuan Fucai makings of medical devices, packing, production. To acquiring product of medical devices production registers certificate to produce medical devices, " medical devices monitors regulation " thirtieth set 5 times halt production, confiscate product and till illegal earning, amerce has right " license of company of production of medical devices " of enterprise condole card punish criterion, but the medical devices that did not obtain production of product of medical devices to register certificate to produce is belonged to necessarily " product quality standard " the product of the national level of the regulation that does not accord with safety of health of safeguard human body and person, belongings, occupation standard, the Yuan Fucai of medical devices that registers card to be being used technically at production to not have tool of makings, packing, production, ought to according to " product quality standard " the 60th regulation gives confiscate.
6. is carried illegally, the processing of custodial storage. Party knows or ought to knowing is to not have register the medical devices of card and offer for production, operator carry, of the convenience condition such as custodial, storage, ought to according to " product quality standard " the 61st regulation confiscates illegal income and manage illegal income 50% above 3 times the following amerce.
7. hides, move, sell off, mar be closed down by medical inspect branch, sequestered article. " medical devices monitors regulation " thirtieth sets, the product that causes accident of quality of medical devices possibly perhaps to causing accident of quality of medical devices reachs concerned data, medical inspect branch can give close down, sequestered. But hide to party, move, sell off, mar be closed down by medical inspect branch, sequestered article ought to not make a provision like where buy, branch of inspect of drug of this kind of case should according to " product quality standard " the 63rd regulation, be hidden to party place, move, sell off, mar goods goods to be worth equivalence above 3 times the following amerce; Have illegal income, be in confiscate illegal earning.
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