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State approvals / Assam / State Drugs Control Administration

Application for grant of registration certificate to Sell, Stock, Exhibit or offer for sale or distribution a medical device including in Vitro Diagnostic Medical Device

DepartmentState Drugs Control Administration
TypeNew
StageOperation / Renewal
Fee₹3,000
AppliedApply on NSWS
Apply on National Single Window System

Documents to submit

#DocumentConditionRequired
1 Self certificate of compliance with respect to Good Distribution Compliance — Required
2 Identity Proof, such as, Aadhar card or PAN Card — Required
3 An undertaking to the effect that the storage requirements to sell, stock, exhibit or offer for sale or distribute a medical device will be complied — Required
4 Details of the applicant or firm including its constitution — Required
5 Documentary evidence in respect of ownership or occupancy on rental of the premises — Required
6 Brief description on other activities carried out by applicant namely, storage, of drugs , medical items , food products , stationeries etc. or any other activities carried out by the applicant in the said premises — Required
7 Details of competent technical staff, under whose direction and supervision the sales activity of medical devices shall be undertaken who shall possess the following educational qualification and experience namely- — Required
8 Hold a degree from a recognized University / Institution: or — Required
9 Is a registered Pharmacist — Required
10 Has passed intermediate examination or its equivalent examination from a recognized Board with one –year experience in dealing with sale of medical devices — Required

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