InVitro Diagnostic Device Import License Service In Chennai

The import of InVitro Diagnostic is governed by the 2017 New Medical Device Rules. For submitting applications and granting permission of import of IVD falling under any Category A, B, C, or D respective online form is required to be submitted on SUGAM, which is a central Licensing Authority for such products. This platform was created by the Central Drugs Standard Control Organization.

Who can apply for InVitro Diagnostic Device Import License?

Foreign manufacturers cannot directly seek for registration in India as applicants. To file their Application for Registration of Imported InVitro Diagnostic Device, they must designate an Indian Entity that is an approved agent or licence holder. The authorised agent may submit an application for an import licence to the CDSCO if they already have a wholesale licence for sale and distribution or a licence to manufacture for sale or distribution. Any business or institution that has been given a "Power of Attorney" by an international manufacturer to handle the importation of in vitro diagnostic devices into India is considered to be an authorised agent.

Forms Required for Application and Permission

 

Application Form to get import license for IVD Diagnostic Device	Approval Form from central Licensing Agency to grant permission to import IVD Diagnostic kit	Risk	Authority to Grant license
MD 14	MD15	A, B, C,&D	CDSCO

 

What is the procedure for requesting an import licence for an in vitro diagnostic device?

Step 1 Evaluation
The first step is to evaluate the product to see if it complies with the fundamental standards needed to submit an application for an import licence in accordance with the Medical Rule of 2017. The evaluation process must be carried out by competent authorities.

Step 2 Classification
The In Vitro Diagnostic Device is categorised according to the Product Risk category if registration under the 2017 Medical Device Rule is necessary.

Step 3 Documentation
The New Medical Devise Rule of 2017 stipulates that certain documents must be kept on hand and duly signed by the signatory authority.

Step 4 Appointment of agent
Then, an overseas manufacturer must appoint an agent through a power of attorney who is licenced to manufacture medical devices and in vitro devices for sale and distribution.

Step 5 Form Filing
Online software generates an application form. The form must be completely filled out, including all attachments.

Step 6 Approvals by Agent
An authorised agent must approve and submit the draught application form.

Step 7 Follow up
Follow-up with the regulatory authority and question management can be done in the event of any uncertainty.

Step 8 Grant of Approval
A License to Import InVitro Diagnostic Device is given if all necessary standards and regulations are met.

       

Validity of License

As long as the licence retention costs are paid as specified in the second schedule prior to the license's 5-year expiration date, the import licence issued under form MD 15 stays valid indefinitely. Only if the licence has not already been suspended or revoked by the Central Drugs Standard Control Organization is this action taken.

Major points

Before submitting an application for a medical device import licence, there are a few things to keep in mind.

01. One needs to confirm that "Free Sale Certificate" is available from GHTF nations.

02. Verify how many manufacturing facilities are included in the application.

03. The Power of Attorney format must follow the instructions in the 2017 regulations for the regulation of medical device rules.

04. The Medical Device Rules 2017 must also be followed while creating the documentation needed for the Device Master File, Site Master File, or any other technical documents.

05. The Apostille and Notary must also be in accordance with the 2017 Medical Device Rules Guideline.

06. Only if an agent has a licence to manufacture for sale and distribution or a licence of wholesale sale and distribution in India is that agent regarded an authorised agent for the grant of licence for an in vitro diagnostic device.

FAQ

 

Does the central Licensing Authority have the power to inspect the overseas manufacturing site of the InVitro Diagnostic Device before the Grant of License?

Only if Central Licensing Authority finds it necessary to inspect an overseas manufacturing site it may carry out an inspection.

Can we change anything after the InVitro Diagnostic gadget has received approval?

Yes, changes can be made to the production process, tools, testing, primary packaging materials, and labelling in accordance with the sixth schedule. For changes to be made, authorization from a qualified authority is needed.

If there are multiple importers, then what all documents are required?

A new agent must submit all necessary paperwork, including a new power of attorney, an MD 14 Form, a manufacturing and wholesale licence, government fees, a label, and a copy of the import licence that the previous importer had been issued. In addition, the Manufacturer must certify that the site master plan, device master plan, and any other technical and regulatory documentation provided to CDSCO by the prior agent have not changed.

Before the Medical Device Rule of 2017, if products are already marketed in India, do they need a License under the new rule?

From the start of the Medical Device Rules 2017, the medical devices that have already been marketed in India may do so for another 18 months or until the license's current expiration date. Predicate Gadgets are those devices.

What all License or authtrosization is required from the overseas Manufacturer for Import License?

In addition to the import licence, a Free Sale Certificate is necessary, which is often given by a competent government in any of the nations (Australia, Canada, and Japan, the countries of the European Union or the United States of America).