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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.
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.
| 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 |
The applicant is required to provide a number of documents for import registration in accordance with part II of the IV schedule of the New Medical Rules of 2017.
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.
The In Vitro Diagnostic Device is categorised according to the Product Risk category if registration under the 2017 Medical Device Rule is necessary.
The New Medical Devise Rule of 2017 stipulates that certain documents must be kept on hand and duly signed by the signatory authority.
Then, an overseas manufacturer must appoint an agent through a power of attorney who is licensed to manufacture medical devices and in vitro devices for sale and distribution.
Online software generates an application form. The form must be completely filled out, including all attachments.
An authorised agent must approve and submit the draft application form.
Follow-up with the regulatory authority and question management can be done in the event of any uncertainty.
A License to Import In Vitro Diagnostic Device is given if all necessary standards and regulations are met.
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.
Before submitting an application for a medical device import licence, there are a few things to keep in mind.
It is a regulatory approval issued by CDSCO for importing in-vitro diagnostic (IVD) devices into India. The license ensures compliance with the Medical Device Rules, 2017.
Indian importers or foreign manufacturers intending to sell IVD devices in India must apply. Foreign manufacturers must appoint an Authorized Indian Representative (AIR).
Form MD-14 (application for import) and Form MD-15 (license issuance) are required. Both are submitted via the CDSCO SUGAM portal.
Documents include ISO 13485 certification, Free Sale Certificate (FSC), Device Master File (DMF), Clinical Evaluation Report, and proof of payment.
The license is valid for five years. Renewal is required to continue importing IVD devices after the validity period expires.