CDSCO Portal for Import License and Registration Certificate

Introduction

The Central Drugs Standard Control Organization (CDSCO) has announced on 15 February 2016 an online Portal for submission of applications in Form 41 for the registration certificate and for import license. Authorized Indian Agents, Importers, Corporates and Foreign Enterprises Holding Indian Subsidiary can use this application Portal. An important document to access this new application system is the Whole Sale Drug License. Additionally, the CDSCO has requested all applicants who have submitted the application via hard copy to the CDSCO portal prior to 15^TH February 2016 are requested to submit the documents through online portal to allow smoother transition for the regulatory body from India to the new systems. The Indian regulatory body believes that this new application portal will make the issuance of registration certificates, communication of application status, raising o queries and response to queries during the regulatory submission process for medical devices, drugs and import licenses easier.

Currently drugs, medical devices and IVD’s are regulated by the CDSCO. There are 14 notified medical devices. However, it is important to note that CDSCO does not have ‘combination products’ and several products such as clips, stapler, contraceptives, sutures, pacing wires etc. are regulated as drugs in India.

Medical devices which require registration in India include spinal needles, cochlear implants, annuloplasty rings, tracheostomy tubes, syringes and needle, dental implants, surgical sealants, heart valves, cardiac stents, orthopedic implants, endotracheal tubes, and catheters, among others. A detailed list of notified medical devices in India can be found here.

Detailed explanation of the checklist for document requirements with the CDSCO is found below.

Form 40
TR6 Challan
Power of Attorney
Schedule D(I)
ISO 13485 Certificate
Full Quality Assurance Certificate
CE Design Certificate
Declaration of Conformity
Free Sale Certificate
Other Regulatory Approvals
PMS report
Plant Master File
Device Master File

Who and How to Apply to Access the Online Registeration Portal for CDSCO

The system can be accessed by using the link http://cdscoonline.gov.in using any standard web browser like Firefox, Google Chrome etc
Using the online registration portal that allows the authorized Indian Agent to apply for registration certificate, import license, track the status of the application and also respond to queries raised by the CDSCO
The user account lists out all the licenses held by it through the country, licenses issued, suspended and cancelled, details of the facilities for manufacturing at each location, import licenses details, details of the technical staff working at each facility etc

Important Points to Remember while Creating your Login Credentials for the application

A PDF form has to be filled out by the Authorized Agent, signed, stamped and uploaded as a part of the process
E-versions of the
- Whole sale drug license,
- Company Address Proof
- Certificate of Incorporation
- Individual’s Aadhar Card (if not available, alternative address proof may be submitted. However, Aadhar Card must be submitted within 2 months of application)
Once the form is filled through the online portal, a verification email will be received on the official email account.
Following the successful online application submission, hard copies must be submitted to the CDSCO office.
Only following their verification, will an email activating your online account be provided

User Profile

Prior to submission of applications, the authorized Indian Agent must update their User Profile. This section includes information on Member Details Contact Person Details, Directors etc. Only once it is successfully filled, will the ‘Form Submission’ section get activated.

Permission Owned

Another important section is Permission Owned. This is, if the user is holding permissions, Registration Certificate or Import License, which are issued through the manual process in the year 2012 or later, then user needs to provide valid permission details through permission owned into the online portal for making applications to the CDSCO for medical devices, drugs and IVD’s.

Summary

Registration can be done with verified credentials via the Online Form Submission
After receiving the verified credentials, the User Profile must be updated. This includes member details, contact information and whole sale drug license.
Only once the User Profile is filled, will the Authorized Indian Agent be able to proceed to Form Submissions.
Prior to submitting New Forms, the Authorized Indian Agent must enter Historical Data. This is data/ registration certificate information obtained by the Firm in Hard Copy format by the CDSCO.
During Form Submission, currently two options are available – Form 40 – for the Registration Certificate and Form 8 for the Import License.
It is important to remember that once the Authorized Indian Agent moves to the Check-list page, the information entered cannot be modified. Hence, make sure to enter all correct details.
If user fills the complete application in one go, then application will be submitted to CDSCO.
- To view Submitted Application, click on Menu ” Form Submission ” Submitted Applications.
- If application is approved by CDSCO, then it will be visible under Approved Applications
- To view Approved Application, click on Menu ” Form Submission ” Approved Applications.
- If application is rejected by CDSCO, then it will be visible under Rejected Applications
- To view Rejected Application, click on Menu ” Form Submission ” Rejected Applications.

This Guide will help users register with the newly developed IT system by the CDSCO. For the registration of medical devices, drugs, cosmetics and IVDs in India, Morulaa HealthTech provides an end to end solution from dossier preparation, submission, follow-up with the CDSCO, labeling requirements, and obtaining the relevant certification.