The medical devices that installs to going all out how qualitative processing

Medical Tourism @ Bumrungrad International

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The medical devices that installs to going all out how qualitative processing



2008-04-17

Case:

Superintendency bureau of medicines and chemical reagents of A city food is supervising the discovery in the examination daily, what some community service station uses inside area under administration is medical X ray diagnoses equipment, its controller is produced for B manufacturer and prove with this plant eligibility; X line ball is in charge of and examine bed is produced for C manufacturer and the eligible proof with this factory. Check via investigation, department of this medical devices manages an enterprise to purchase from some medical devices, manufacturer of B, C produces a business for medical devices, all obtained medical the product of medical devices of X ray diagnostic equipment registers certificate, two register certificate to carry bright product composition and structure all include canal of ball of line of controller, X and disgnostic couch. Manufacturer of B, C affirms these components are produced before for its, of the sale medical the component with X ray diagnostic overall equipment, but all deny this machine to be its production, sale.

Difference:

In this case, what what this community service station uses is medical X ray diagnoses equipment, should be other (blame manufacturer behavior) what produce with two different manufacturer is medical in X ray diagnostic equipment still spendable component goes all out to install and be become, with respect to this machine how qualitative, execute the law personnel interior arose the following 4 kinds of different opinions:

The first kind of opinion thinks, this machine should qualitative register the certificate, medical devices that has eligible proof to do not have a product. Because this machine fastens the part that produces by different manufacturer to go all out to install and be become, although each components have,register card, but whole is more than a part, can maintain this overall the medical devices that registers certificate to do not have a product. Because of this machine each components all have eligible proof, so this opportunity has eligible proof.

The 2nd kind of opinion thinks, this machine should qualitative register the certificate, medical devices that proves without qualification to have a product. Each components have this opportunity the eligible proof of manufacturer, but that just proves each components are eligible, and assemble overall hind, overall prove without qualification. And each components all have this opportunity register card, so cannot qualitative the medical devices that registers certificate to do not have a product.

The 3rd kind of opinion thinks, this machine should qualitative register the certificate, medical devices that proves without qualification to do not have a product, because this machine is comprised by the part that different manufacturer produces, overall not be manufacturer production, however other spells the component of two manufacturer to install and be become, spell the person that holds this plane to be not had apparently produce and examine the ability of this machine, answer so qualitative register the certificate, medical devices that proves without qualification to do not have a product.

The 4th kind of opinion thinks, although install and this machine is become to go all out, but each component all has register card and certificate of approval, cannot qualitative register the card, medical devices that proves without qualification to do not have a product, with respect to existing legal laws and regulations, of short duration handles this kind to spell outfit behavior without specific provision. (case offers: Jiangxi saves medicines and chemical reagents of Jingdezhen city food to superintend bureau Wang Zhangming)
Review analyse:

Medical devices is to point to perhaps combine alone use the instrument at human body, equipment, implemental, data other perhaps goods, include the software of a need; The function that its use within watch of human body body and body is not to use the method that pharmacological, immunology perhaps metabolizes to obtain, but the auxiliary function with the particular move since the participation of these methods. The anticipation of use medical devices the purpose includes: The precaution to the disease, diagnose, cure, custody, alleviate; Right injure or the diagnosis of deformity, cure, custody, alleviate, compensation; Right anatomize or the research of physiology process, replace, adjust and gravid control. Because medical devices has the effect that cannot replace in medical treatment service, the life health of people of can immediate impact is safe, the State Council was promulgated in January 2000 " medical devices monitors regulation " , to the classification of medical devices, product production is registered, of license of license of company of production of medical devices, management business of medical devices, medical devices supervise and legal responsibility made specific provision.

In this case, what some community service station uses is medical X ray diagnostic equipment is other (blame manufacturer behavior) in this equipment that produces before with B factory and C factory still spendable component goes all out to install and be become. Although " medical devices monitors regulation " right how qualitative go all out install medical devices to did not make specific provision, but the “ unreliability ” of this kind of medical devices is clearly, the reason basically has 2: The first, each components of this equipment are apparently from what fall into disuse medical X ray diagnostic equipment is overall on tear open come down, although these components belong to eligible product at first, but use exceed period of efficacy, the security of the product and effectiveness index all can arise to cause the harm to human body not stable and easily. For example, the data that uses the tutelar appearance that eliminate to may show an error or signal, cause thereby by accident examine, incur loss through delay treats an opportunity. The 2nd, to say the least, although spell each component qualification with overall outfit, unwarrantable also spell the qualification with overall outfit. Because different medical devices produces manufacturer to be in the craft of products plan, treatment, difference that assembles the respect such as the technology, go all out of outfit overall and likely existence component does not deserve to cover, do not adjust wait for all sorts of breakdown hidden trouble.

Go all out to what some community service station uses outfit is medical X ray diagnostic equipment is OK from administration and product safety two respects give qualitative. From administration respect, in this case, this spells furnish is to regard as fully overall use, execute the law consequently personnel should from overall angle is not from composition the angle of each overall components holds a product. As overall, this equipment and B, C produces manufacturer twice to have nothing to do formerly, be by do not have produce and examine the tripartite of ability goes all out of outfit, go up in this bit, the 3rd kind of opinion of this case is relatively reasonable, 3 kinds of opinions have the rest biasedding place, biasedding dot depends on pay close attention to end ministry only and failing to see a problem from whole. Accordingly, this spells furnish to have ought to qualitative register card to do not have a product, produce the business license, “ that does not have product certificate of approval without medical devices 3 without ” product. From product safety aspect, this spells furnish to answer fully by qualitative for “ ” of insecure medical devices. The diction of ” of “ insecure medical devices originates " medical devices monitors regulation " thirtieth 2 regulation, the meaning is ” of “ unwarrantable safety, effective medical devices. Medical devices is insecure have a variety of state, include “ among them 3 without ” product. For example, without registered medical devices, did not obtain a government the accuracy that means this kind of medical devices, dependability, security, effectiveness to concern a section approbate and approve, its function and index do not accord with safe requirement likely and form healthy to the public harm, because this is insecure.

According to afore-mentioned qualitative, the principal part that this case needs to assume legal responsibility has 3, namely operator of generator of medical devices, medical devices and the some community service station that serve as medical establishment. The first, in this case, the case of generator of medical devices is very not clear, need executes the law personnel is investigated through after investigation affirms, giving. If this generator is belonged to,have medical devices produces business license and go all out outfit register card without the product medical X ray diagnoses equipment, ought to according to " medical devices monitors regulation " thirtieth 5 regulation grants to punish; If this generator is belonged to,go all out outfit is medical of X ray diagnostic equipment (medical X ray diagnostic equipment belongs to 2 kinds, 3 kinds of medical devices) , ought to according to " medical devices monitors regulation " thirtieth 6 regulation gives punishment. The 2nd, in this case, the medical devices that operator of medical devices manages is belonged to register the certificate, medical devices that proves without qualification without the product, ought to according to " medical devices monitors regulation " thirtieth 9 regulation gives punishment. The 3rd, in this case, the some community service station that serves as medical establishment uses the medical devices that registers certificate of approval of card, product without the product, ought to according to " medical devices monitors regulation " the 42nd regulation gives punishment. In addition, a series of this illegal behavior are like those who make crime, return the criminal responsibility that ought to find out relevant responsibility person lawfully. (case reviews analyse: Admire of man of courtyard of law of university of Chinese politics and law beautifuls)