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The Indian medical regulatory system has

become more complicated in recent years. In
the past, medical devices did not need to be
approved at all, but that is not the case today.
In India, there are about 30 device “families”
that outline which specific medical devices
need to be registered.

With the rising opportunities in India comes

increasing regulations that companies must
face and overcome. With the assistance of a
highly experienced third-party regulatory
compliance consultant such as Pacific Bridge
Medical, the registration process is much less
complex. We can help you prepare and
submit the required documents and materials
to the relevant regulatory agencies in India.

REGULATORY BODIES IN THE INDIAN GOVERNMENT - FOR MEDICAL DEVICE REGISTRATION IN INDIA

✓The Central Drug Standards Control Organization (CDSCO) is India’s main regulatory
body for pharmaceuticals and medical devices.
✓The Drug Controller General of India (DCGI) is the key official within the CDSCO. The
DCGI is responsible for the approval of the manufacturing of certain drugs (vaccines, large
volume parenterals, blood products, r-DNA derived), specific medical devices, and new
drugs.
✓In India, the manufacturing, import, sale, and distribution of medical devices are regulated
under India’s Drugs & Cosmetic Act and Rules (DCA).
IN INDIA, MEDICAL DEVICES REQUIRED TO BE REGISTERED BEFORE THEY CAN BE SOLD:

Currently only 40-50 medical devices require registration. For all other medical devices that do not
require registration, the manufacturer should obtain a No Objection Certificate (NOC)from the
DCGI. The NOC is a letter from the DCGI stating that the product does not require registration and
can be imported freely into India.

WHAT ARE THE DIFFERENT REGULATORY CLASSIFICATIONS FOR MEDICAL DEVICES?

Currently there is not a formal regulatory classification scheme, however, draft regulations outline
the following:

• Class A – Low Risk (example: thermometers, tongue depressors)

• Class B – Low-moderate Risk (example: hypodermic needles, suction equipment)
• Class C – Moderate-high risk (example: lung ventilator, bone fixation)
• Class D – High Risk (example: heart valves, implantable devices)

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 G M P - Documentation
G2 Business Excellence Consulting

WHAT DOES THE REGISTRATION PATHWAY LOOK LIKE FOR REGULATED MEDICAL DEVICES?

(Non-Regulated Medical Devices with a NOC are exempt from registration)

• Companies must register regulated medical devices with the DCGI before they can be introduced
into the Indian market.
• For new medical devices, prior approval from the DCGI must be obtained before the device can
apply for registration.
• Upon receipt of the application with fees, evaluation begins.
• The DCGI may require clinical testing in India or abroad.
• The DCGI may visit the manufacturing premises during the process.

Summary of Steps for the Medical Device Registration Process in India

1.Appoint a local agent in India to be the applicant and license holder

2.Prepare Device Master File (DMF)
3.Prepare Plant Master File (PMF)
4.Prepare application Form w/supporting documents
5.Submit above documents to DCGI with fees
6.DCGI reviews and sends back an inquiry letter
7.Applicant responds and addresses inquiries made by the DCGI
8.DCGI may request technical presentation
9.Approval

Timeline: The registration of medical devices in India can take between 9 and 18 months if there
are no clinical trials.

IS LOCAL TESTING (TYPE TESTING/SAMPLE TESTING) REQUIRED FOR REGISTRATION?

No, foreign testing reports are generally accepted.

ARE CLINICAL STUDIES REQUIRED FOR REGISTRATION?

This is determined on a case-by-case basis. In many cases, foreign clinical data is accepted.

IS APPROVAL IN THE COUNTRY OF ORIGIN REQUIRED FOR REGISTRATION?

Yes, approval in the Country of Origin is required for medical device registration in India.

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© G2 BusinessExcellence (Consulting) 2019 - All Rights Reserved