Churchyard II kind, III kind medical devices registers application material requirement

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Churchyard II kind, III kind medical devices registers application material requirement

Churchyard II kind, III kind medical devices registers application material requirement first

(one) churchyard medical devices registers application form

(2) proof of qualification of company of production of medical devices

(3) product technology report

(4) safe risk analyses a report

(5) applicable product standard and specification

(6) product function measures a report oneself

(7) medical devices detects issued product registers the orgnaization detect report

(8) medical devices is clinical test data (specific refer means to see this method accessory 12)

(9) manual of medical devices

(10) system of product production quality is assessed (attestation) valid proof file

(11) the ego that refers material authenticity assures to state

If need us to act as agent, we all can offer above document example, in order to offer reference

Churchyard II kind, III kind medical devices registers application material requirement afresh

(one) churchyard medical devices registers application form

(2) proof of qualification of company of production of medical devices

(3) former medical devices registers certificate

(4) medical devices detects issued product registers the orgnaization detect report

(5) applicable product standard and specification

(6) report of product quality trace

(7) manual of medical devices

(8) system of product production quality is assessed (attestation) valid proof file

(9) belong to this method thirtieth of the 5th chapter of 4 case, ought to submit corresponding circumstance specification and proof sex document

(10) the ego that refers material authenticity assures to state

If need us to act as agent, we all can offer above document example, in order to offer reference

Note:

4 medical devices register thirtieth following content produces change in certificate, manufacturing company ought to rise from the day that produces change

.....Change of the application inside 30 days registers afresh:

(one) model, norms

(2) manufacturing address

(3) product standard

(4) product performance structure and composition

(5) product suitable scope