About clearing medical devices registers administrative document to concern the announcement of the problem

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About clearing medical devices registers administrative document to concern the announcement of the problem

The country feeds medical inspect to fetters [2008]518 date

Medicines and chemical reagents of food of each province, municipality, municipality directly under the Central Government controls management board (medicines and chemical reagents controls management board) :

Register management for farther normative medical devices, national provision medicines and chemical reagents supervises management board to registered normative sex file of management to undertake clearing to partial medical devices. Inform concerned item as follows now:

One, the day that releases from this announcement rises, following file gives revocatory:
(one) fulfil about carrying out " admittance of market of product of medical devices examines a regulation " the announcement of concerned problem (traditional Chinese medicine implement 1996 〕 of inspect word 〔 the 70th) , include its accessory 1 " admittance of market of product of medical devices examines a regulation " executive specification, accessory 2 " of short duration of clinical try out provides product of medical devices all right " ;
(2) about print and distribute " of short duration of clinical test and verify provides product of medical devices all right " announcement (traditional Chinese medicine implement inspect word 〔 1997 〕 the 280th) ;
(3) about print and distribute " entrance medical devices is registered detect regulation " announcement (2001 〕 of 〔 of instrument of inspect of traditional Chinese medicine 130) ;
(4) about be opposite the 3rd kind of medical devices registers entrance medical devices, churchyard the announcement that makes a certain number of compensatory specifications (2001 〕 of 〔 of instrument of inspect of traditional Chinese medicine 478) ;
(5) register additional provision about medical devices of print and distribute (one) announcement (2002 〕 of 〔 of instrument of inspect of traditional Chinese medicine 259) ;
(6) about print and distribute " medical devices registers additional provision (2) " announcement (2003 〕 of 〔 of instrument of inspect of traditional Chinese medicine 119) .

2, basis " medical devices registers administrative measure " (supervisory management board of national provision medicines and chemical reagents makes the 16th) the 15th the first regulation, following medical devices can execute the complement after the entrance registers to detect: System of scanning of fault of X ray computer (CT) , system of scanning of fault of positron emissive computer (system of scanning of fault of emissive computer of PET) , odd photon (SPECT) , ultrasonic of stone crusher of the bow wave outside body, large-scale color is diagnosed.

3, the condom product of executive state level, clinical trial data can be not provided when application is registered.

National provision medicines and chemical reagents controls management board
28 years on September 16

Supervisory management board of national provision medicines and chemical reagents clears partial medical devices registers document of administrative plan plasticity

Released on September 19, 2008

Register management for farther normative medical devices, national provision medicines and chemical reagents supervises management board to registered normative sex file of management to undertake clearing to partial medical devices. 　　
.
One, the day that releases from this announcement rises, following file gives revocatory: 　　
.(one) fulfil about carrying out " admittance of market of product of medical devices examines a regulation " the announcement of concerned problem (traditional Chinese medicine implement 1996 〕 of inspect word 〔 the 70th) , include its accessory 1, accessory 2; 　　
.(2) about print and distribute " of short duration of clinical test and verify provides product of medical devices all right " announcement (traditional Chinese medicine implement inspect word 〔 1997 〕 the 280th) ; 　

.(3) about print and distribute " entrance medical devices is registered detect regulation " announcement (2001 〕 of 〔 of instrument of inspect of traditional Chinese medicine 130) ; 　
.(4) about be opposite the 3rd kind of medical devices registers entrance medical devices, churchyard the announcement that makes a certain number of compensatory specifications (2001 〕 of 〔 of instrument of inspect of traditional Chinese medicine 478) ; 　　
.(5) register additional provision about medical devices of print and distribute (one) announcement (2002 〕 of 〔 of instrument of inspect of traditional Chinese medicine 259) ; 　　
.(6) about print and distribute " medical devices registers additional provision (2) " announcement (2003 〕 of 〔 of instrument of inspect of traditional Chinese medicine 119) . 　
.
2, basis " medical devices registers administrative measure " (supervisory management board of national provision medicines and chemical reagents makes the 16th) the 15th the first regulation, system of scanning of fault of X ray computer (CT) , system of scanning of fault of positron emissive computer (system of scanning of fault of emissive computer of PET) , odd photon (SPECT) , ultrasonic of stone crusher of the bow wave outside body, large-scale color diagnoses: . 　　
.
3, the condom product of executive state level, clinical trial data can be not provided when application is registered.