Know Your Service
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
Dear user, you will be redirected to EODB portal for this service. If not already registered, please register first otherwise login to avail the service.
- If the applicant is a first time user, he/she needs to click the Register Tab provided in top right corner in this page and then get registered with the necessary fields such as Full Name, Mobile No., Email id (which is not mandatory), State and Password.
- Then the applicant needs to login with the credentials, by clicking the Login Tab.
- After the applicant has logged on to the system, he/she needs to click the Apply Online tab and select the service they want to apply for and click the apply button after going through the Requirements tab.
- Applicant has to fill up the form and upload the required supporting documents.
- On final submission of the form, applicant has to pay the requisite amount.
- Once the payment is successful it will be forwarded to the higher officials for further processes. An acknowledgement will be generated containing the application reference no., the same will be notified over SMS and Email id of the applicant.
- An SMS and Email alert is sent to applicant on completion of the service. The applicant needs to respond to the SMS and Email regarding completion of the service.
- After successful completion of the service, 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 is generated. The applicant will be notified about this over SMS and Email and the applicant can download it from ARTPS portal.
Supporting Documents :
1. Self certificate of compliance with respect to Good Distribution Compliance
2. Identity Proof, such as, Aadhar card or PAN Card.
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.
4. Details of the applicant or firm including its constitution
5. Documentary evidence in respect of ownership or occupancy on rental of the premises.
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.
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-
a) Hold a degree from a recognized University / Institution: or
b) Is a registered Pharmacist.
c) Has passed intermediate examination or its equivalent examination from a recognized Board with one –year experience in dealing with sale of medical devices.
Stipulated Time Limit :
Not Mentioned
Fees:
Rs. 3000/-
ONLINE: The requisite fees to be paid through EGRAS payment gateway only.
OFFLINE:The Head of Account is "0210-Medical and Public Health, 04- Public Health, 104-Fees and Fines".
