Medical devices manages business license to run way

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Medical devices manages business license to run way

(bureau make the 15th)

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." license of management business of medical devices runs way " supervised joint hearing of Wu of management board bureau to discuss via national provision medicines and chemical reagents on June 25, 2004 through, grant to announce now, apply since the day that announce.


Two years on August 9

General principles of the first chapter

The first controls government to strengthen what manage a license to medical devices, basis " medical devices monitors regulation " , make this way.

The 2nd " license of management business of medical devices " hair card, change card, change to reach supervisory management applicable this method.

The 3rd manages the 2nd kind, the 3rd kind of medical devices ought to hold " license of management business of medical devices " , but the 2nd kind of a few medical devices that can assure its security, effectiveness through convention management in current process need not apply for " license of management business of medical devices " . Do not need application " license of management business of medical devices " directory of product of the 2nd kind of medical devices supervises management board to make by national provision medicines and chemical reagents.

Supervisory management board of medicines and chemical reagents of provision of the 4th state is in charge of the whole nation " license of management business of medical devices " supervisory government works.

Province, municipality, municipality directly under the Central Government (food) supervisory management department of medicines and chemical reagents is responsible inside this area under administration " license of management business of medical devices " hair card, change card, change and supervisory management job.

The city stage that sets an area (food) supervisory administration of medicines and chemical reagents perhaps is saved, municipality, municipality directly under the Central Government (food) the prefectural stage that supervisory management department of medicines and chemical reagents sets directly (food) supervisory administration of medicines and chemical reagents is responsible inside this area under administration " license of management business of medical devices " day-to-day supervisory management works.

Supervisory management board of medicines and chemical reagents of provision of the 5th state carries out medical devices to manage quality standard to run a system stage by stage. Medical devices manages quality management standard to supervise management board organization to make by national provision medicines and chemical reagents.

The 2nd chapter applies for " license of management business of medical devices " condition

The 6th application " license of management business of medical devices " ought to have following requirement at the same time:

(one) have the quality administration that suits with operation and photograph of scope of operations or full-time quality administrator. The relevant and professional record of formal schooling that quality administrator ought to have a country to approbate or title;

(2) the management place that has the opposite independence that suits with operation and photograph of scope of operations;

(3) have what suit with operation and photograph of scope of operations to store condition, include to have those who accord with requirement of item characteristics of medical devices to store establishment, equipment;

(4) ought to build perfect product quality to run a system, include to purchase, replenish onr‘s stock is checked and accept, system of check of custodial, delivery of cargo from storage, quality trace mixes storage the report system of undesirable incident;

(5) the technology that ought to have the photograph of product of medical devices that runs with its to suit grooms and the ability of after service, perhaps agree provide technical support by tripartite.

The 7th application " medical devices manages business license " , must pass (food) the examination of supervisory management department of medicines and chemical reagents is checked and accept.

Province, municipality, municipality directly under the Central Government (food) medicines and chemical reagents supervises management department ought to according to this method, join this area under administration actual, make medical devices manage enterprise examination to check and accept a standard,

The 8th " medical devices manages business license " the administrative category that stated scope of operations ought to classify the regulation in catalog according to medical devices, kind code name name is affirmatory.

The 3rd chapter applies for " license of management business of medical devices " program

The 9th plans to do enterprise seat province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents is in charge of accepting " license of management business of medical devices " the application that send card.

The 10th province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents ought to be in website of its executive authority perhaps applies for to accept a place make public show application " medical devices manages business license " requires condition, program, .

Eleventh application " medical devices manages business license " when, ought to submit following data:

(one) " application form of license of management business of medical devices " ;

(2) department of industrial and commercial administration issued company name beforehand approve proves a file;

(3) the Id that plans to do company quality administrator, record of formal schooling or title proof photocopy and resume;

(4) plan to handle company origanization construction and function;

(5) the situation plan that plans to do an enterprise to register address, storehouse address, ichnography (make clear an area) , building property right proves (perhaps rent an agreement) Xerox;

(6) plan to do company product quality to manage system file to reach store list of establishment, equipment;

(7) plan to do company scope of operations.

Dozenth an applicant ought to to plan to do enterprise seat province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents puts forward " license of management business of medical devices " the application that send card.

Put forward to the applicant " medical devices manages business license " the application that send card, province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents ought to make processing respectively according to following case:

(one) application item does not belong to this sectional limits of one‘s functions and powers, ought to make the decision that does not grant to accept immediately, send " do not grant to accept advice note " , inform an applicant to apply for to concerned branch;

(2) of the mistake that application material existence can correct on the spot, ought to allow an applicant to correct on the spot;

(3) application material is not all ready perhaps do not accord with legal form, perhaps ought to be in on the spot 5 workaday indrawn applicants are given out " make good omissions material advice note " , one-time the entire content that informs need to make good omissions. Exceed the time limit does not inform, it is namely since the day that gets application material accept;

(4) application item belongs to this sectional limits of one‘s functions and powers, all ready, coincidence method decides application material form, or the applicant is referred according to the requirement make good omissions entirely of application material, send " accept advice note " . " accept advice note " ought to build accept special rule and make clear accept date.

Thirteenth province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) examination of management enterprise of medical devices of basis of supervisory administration of medicines and chemical reagents checks and accept a standard to undertake the spot check to planning to do a business, undertake checkup to filing a material according to this method.

The 14th province, municipality, municipality directly under the Central Government (food) supervisory management department of medicines and chemical reagents ought to rise in accepted day make inside 30 weekday whether the nucleus is sent " license of management business of medical devices " decision. Think to accord with a requirement, ought to make allow nucleus send " license of management business of medical devices " decision, remove indrawn applicant 10 days to issue in the day that makes a decision " license of management business of medical devices " . Think not to accord with a requirement, ought to written announcement applicant, show reason, inform an applicant to enjoy the right that application administration is reconsidered or carries lawsuit of politics of start on a journey lawfully at the same time.

The 15th (food) when medicines and chemical reagents supervises management department to undertake checkup to the applicant‘s application, ought to fair show examine and approve process and examine and approve a result. Applicant and interests person can are opposite immediate impact the matter that its weigh golden eggs refers written opinion to have allegation and argue one‘s case.

" license of management business of medical devices " application involves what significant increase concerns between applicant and other directly, (food) the right that medicines and chemical reagents controls management department to ought to inform applicant and interests person to enjoy application hearing of witnesses lawfully.

(food) supervisory management department of medicines and chemical reagents thinks " license of management business of medical devices " involve public interest, ought to to social announcement, hold hearing of witnesses.

The 16th province, municipality, municipality directly under the Central Government (food) supervisory management department of medicines and chemical reagents ought to announce what had issued " license of management business of medical devices " concerned information, the public has authority to undertake inquiring.

The 4th chapter " license of management business of medical devices " change and change hair

The seventeenth " license of management business of medical devices " the modificatory cent of the project is changed to allow item and register item to change.

Permissive item change includes quality administrator, register address of address, scope of operations, storehouse (include storehouse of increase and decrease) change.

Change of the item that register is to point to afore-mentioned item beyond the change of the any other business.

The 18th change " medical devices manages business license " allow item, management enterprise of medical devices ought to fill in " license of management business of medical devices " modificatory requisition, carry occur simultaneously to build this enterprise seal " business charter " and " medical devices manages business license " Xerox.

Change quality administrator, ought to submit letter of the Id that holds the post of quality administrator newly, record of formal schooling at the same time or title certificate photocopy; Modificatory enterprise registers an address, the property right that ought to refer the address after change at the same time proves or rent graph of consultative photocopy, situation, ichnography and memory condition specification; Change scope of operations, ought to refer the specification of the photocopy that plans to manage a product to register card and corresponding memory condition at the same time; Change storehouse address, the property right that ought to refer address of the storehouse after change at the same time proves or rent graph of consultative photocopy, situation, ichnography and memory condition specification.

The 19th medical devices manages an enterprise to apply for to change those who allow item, province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents ought to be in since the day that hears medical devices to manage an enterprise to permit item change to apply for inside 15 weekday according to medical devices management enterprise examines check, and by province, municipality, municipality directly under the Central Government (food) the decision that medicines and chemical reagents controls management department to make allow change perhaps forbid to change; Need spot is acceptable, the decision that allow is changed or prohibits change ought to be made inside 20 weekday since accepted day.

Province, municipality, municipality directly under the Central Government (food) medicines and chemical reagents supervises management department to make allow change a decision, ought to be in " license of management business of medical devices " the content that change records on carbon and time; Forbid to change, ought to written tell an applicant and show reason, inform an applicant to enjoy the right that application administration is reconsidered or carries lawsuit of politics of start on a journey lawfully at the same time.

Management enterprise of medical devices is changed " license of management business of medical devices " after allowing item, ought to change procedures to the concerning that is versed in administration department conduction business registers business lawfully. After change " medical devices manages business license " period of efficacy is changeless.

Management enterprise of the 20th medical devices is managed because of breaking the law already by (food) investigation of put on record of supervisory management department of medicines and chemical reagents, but have not of end a case; Perhaps had received administration to punish a decision, but have not fulfill punishment, province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) medicines and chemical reagents supervises an administration to break down is accepted or ought to examine its " license of management business of medical devices " permissive item changes application, till the case handles end.

Management enterprise of the 21st medical devices is changed " license of management business of medical devices " of the item that register, ought to be in after change of approve of department of industrial and commercial administration inside 30 days fill in " license of management business of medical devices " modificatory requisition, to province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents applies for " license of management business of medical devices " change is registered. Province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents ought to be in since the day that gets modificatory application inside 15 weekday deal with modificatory formalities for its, inform an applicant.

The 22nd " medical devices manages business license " after the item that register is changed, province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents ought to be in " license of management business of medical devices " the content that change records on carbon and time. After change " medical devices manages business license " period of efficacy is changeless.

Component of the 23rd company, amalgamative perhaps cross former administer migratory, ought to apply for afresh according to the regulation of this method " license of management business of medical devices " .

The 24th " license of management business of medical devices " period of efficacy is 5 years. At the expiration of one‘s term of office of period of efficacy, need continues to manage product of medical devices, management enterprise of medical devices ought to be before at the expiration of one‘s term of office of period of efficacy 6 months, to province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents applies for to change hair " license of management business of medical devices " .

Province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents stipulates according to this method trade card applies for to undertake checkup.

Province, municipality, municipality directly under the Central Government (food) supervisory management department of medicines and chemical reagents ought to be in " license of management business of medical devices " make before at the expiration of one‘s term of office of period of efficacy whether its change allow the decision of card. Exceed the time limit did not make a decision, regard as agree to change testimony and grant to fill do corresponding procedure.

Province, municipality, municipality directly under the Central Government (food) medicines and chemical reagents supervises management department to think to accord with a requirement, ought to be in " license of management business of medical devices " give when at the expiration of one‘s term of office change hair new evidence, call in former " license of management business of medical devices " ; Do not accord with a condition, ought to deadline undertakes rectifying and reform, the condition still does not accord with after rectifying and reform, ought to cancel when at the expiration of one‘s term of office of period of efficacy former " license of management business of medical devices " , written tell an applicant and show reason, inform an applicant to enjoy the right that application administration is reconsidered or carries lawsuit of politics of start on a journey lawfully at the same time.

The 25th medical devices manages enterprise losing " license of management business of medical devices " , ought to instantly to (food) medicines and chemical reagents monitors management department report, be in province, municipality, municipality directly under the Central Government (food) publish on the media that supervisory management department of medicines and chemical reagents appoints lost property notice. Province, municipality, municipality directly under the Central Government (food) supervisory management department of medicines and chemical reagents ought to publish in the enterprise since the day of lost property notice full after a month, reissue according to former approve item " license of management business of medical devices " . Reissue " license of management business of medical devices " with former " medical devices manages business license " period of efficacy is identical.

The 5th chapter supervises an examination

The 26th superior (food) supervisory management department of medicines and chemical reagents ought to be strengthened right inferior (food) the supervisory examination that medicines and chemical reagents supervises management department to carry out medical devices to manage a license, correct administration in time to permit the illegal action in carrying out.

The 27th (food) supervisory management department of medicines and chemical reagents ought to be built " license of management business of medical devices " the hair card, job file that changes card, change and the aspect such as supervisory examination, go up in the 1st week general of every quarter quarter " license of management business of medical devices " hair card, change on card, change and the circumstance newspaper such as supervisory examination one course (food) medicines and chemical reagents supervises management department. To becoming invalid lawfully, call in " medical devices manages business license " , province, municipality, municipality directly under the Central Government (food) supervisory management department of medicines and chemical reagents ought to build archives to save 5 years.

The 28th (food) the supervisory examination that medicines and chemical reagents supervises management department to ought to strengthen pair of medical devices to run a company. The main content of supervisory examination includes:

(one) legal representative of company name, industry or chief and quality administrator are fluctuant circumstance;

(2) the enterprise registers address and storehouse address fluctuant circumstance;

(3) condition of business place, memory and basically store circumstance of establishment, equipment;

(4) the execution of the main item such as scope of operations and fluctuant circumstance;

(5) the executive circumstance of system of management of company product quality;

(6) the concerned item that other need inspects.

The 29th supervisory examination can take written examination, spot examination written perhaps the kind that ties with spot examination. Medical devices manages an enterprise to have one of following state, (food) supervisory management department of medicines and chemical reagents must undertake the spot checks:

(one) the enterprise of new start of on one year;

(2) the enterprise of problem of the existence in inspection of on one year;

(3) because violate concerned law, statute, the enterprise that is punished by administration;

(4) (food) the other company that supervisory management department of medicines and chemical reagents thinks to need to undertake the spot is checked.

Thirtieth " license of management business of medical devices " change testimony in those days, supervisory examination and change card to examine can undertake along with all the others.

Thirtieth (food) when medicines and chemical reagents supervises management department to manage an enterprise to undertake supervisory checking to medical devices lawfully, ought to mix the circumstance of supervisory examination processing result on record, by the file after supervisory examination staff signs. (food) medicines and chemical reagents supervises management department ought to announcement is in " license of management business of medical devices " the result that spot examination records on carbon.

Thirtieth has one of following state 2 times, " license of management business of medical devices " cancel by the former office that send card:

(one) " medical devices manages business license " at the expiration of one‘s term of office of period of efficacy did not apply for or did not change testimony permissibly;

(2) management enterprise of medical devices stops what manage or shut lawfully;

(3) " license of management business of medical devices " by lawfully cancel, recall, revoke, call in or announce to disable;

(4) force majeure brings about medical devices to cannot manage an enterprise normally;

(5) the regulation ought to cancel law, code " license of management business of medical devices " other state.

(food) supervisory management department of medicines and chemical reagents is cancelled " license of management business of medical devices " , labour informs of commercial firm politics inside 5 since day weekday that ought to cancel oneself management department, announce to the society.

Responsibility of law of the 6th art of composition

Do sth without authorization of management company of 3 medical devices changes thirtieth of quality administrator, by (food) supervisory management department of medicines and chemical reagents instructs deadline to correct. Refus of exceed the time limit does not correct, place fine 10 thousand yuan below with 5000 yuan of above.

Change of do sth without authorization of management company of 4 medical devices registers thirtieth of address, storehouse address, by (food) supervisory management department of medicines and chemical reagents instructs deadline to correct, give notice of criticism, be in 5000 yuan of above 20 thousand yuan of the following amerce.

Do sth without authorization of management company of 5 medical devices enlarges thirtieth scope of operations, lower management requirement, by (food) supervisory management department of medicines and chemical reagents instructs deadline to correct, give notice of criticism, be in 10 thousand yuan of above 20 thousand yuan of the following amerce.

6 applicants conceal thirtieth to perhaps offer false data to apply for about the circumstance " license of management business of medical devices " , province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents is accepted to applying for not to grant or do not grant the nucleus is sent " license of management business of medical devices " , give a warning. The applicant must not apply for again inside 1 year " license of management business of medical devices " .

Thirtieth 7 applicants are obtained with the wrong step such as deceit, bribery " license of management business of medical devices " , (food) medicines and chemical reagents supervises management department ought to cancel its " license of management business of medical devices " , give a warning, be in 10 thousand yuan of above 20 thousand yuan of the following amerce. The applicant must not apply for again inside 3 years " license of management business of medical devices " .

8 medical devices manage thirtieth the enterprise has one of following action, (food) supervisory management department of medicines and chemical reagents ought to instruct deadline to correct, give a warning; Refus of exceed the time limit does not correct, place fine 20 thousand yuan below with 10 thousand yuan of above:

(one) alter, buy in and sell at a profit, rental, lend " license of management business of medical devices " perhaps make over illegally with other form " license of management business of medical devices " ;

(2) surmount " license of management business of medical devices " stated scope of operations develops management activity;

(3) concerned condition is concealed in supervisory examination, offer false data to perhaps reject to provide the real data that reflects its to manage a case.

Thirtieth is in 9 times " license of management business of medical devices " hair card, change card, change and there is the other state that offends relevant law, code to set in supervisory management, according to the formulary processing of concerned law, code.

Supplementary articles of the 7th chapter

The 40th " license of management business of medical devices " include original and copy. " license of management business of medical devices " original and carbon have coequal law effectiveness. " medical devices manages business license " original ought to the marked place that park medical devices runs an enterprise to run a place.

" license of management business of medical devices " ought to carry legal representative of bright company name, industry, controller and quality administrator full name, scope of operations, register address of address, storehouse, licence the project such as date of card of mechanism of card of date of date, licence running water, hair, hair, period of validity.

The 41st " license of management business of medical devices " by national provision medicines and chemical reagents supervisory management board is united print. " medical devices manages business license " style of original, carbon and number method, by national provision medicines and chemical reagents supervisory management board is united make.

This the 42nd method is carried out since the day that announce. Supervisory management board of national medicines and chemical reagents makes the 19th " management enterprise of medical devices supervises administrative measure " abolish at the same time.