Regulatory services India

When exporting medical devices to India, an import license is required.

Assure your products and importation processes are regulatory compliant.

When exporting medical devices to India, an import license is required. Through a local agency (the manufacturer’s India Authorized Importer (IAI)), this import license can be obtained at the Central Drug Control Organization (CDSCO). The IAI can have different roles: a local distributor, a subsidiary or an independent entity.

The registration process, to obtain approval to sell medical devices in India, can be divided in two groups:

Registration of notified medical devices
Registration of non-notified medical devices (non-sterile, non-measuring)

The difference is made based on the product’s needs, associated risks, purpose and functionality. The non-notified (or self-notified) medical devices are basically all medical devices not mentioned under the notified medical devices by the official authorities and its registration process is less stringent.

Registration of notified medical devices

The classification of notified medical devices in India (which falls under the new Medical Devices Rules, 2017, updated in 2020) is done based on the risk to a patient’s health. The current risk classifications are:

Class A: devices with the lowest risk (e.g., thermometers and alcohol swabs);
Class B: devices with low to moderate risk with minimal or no invasiveness (e.g., needle kits and suction cannula);
Class C: devices with moderate to high risk (e.g., bone cement, bifurcation stents and catheters);
Class D: devices with high risk (e.g., coronary stents and cardiac catheterization kits).

Registration of notified medical devices

In India, 20+ product categories have been listed as "Notified Medical Devices" by the CDSCO. The list of notified medical devices includes for instance catheters, blood pressure monitors, MRI equipment and dialysis machines. This list is subject to extensive review by the CDSCO, and changes might occur over time.

View Resources

The India medical device or IVD registration process for notified medical devices follows several steps.

Step 1:

Determine what the product requirements are for registration.

To define the classification and regulatory status, the latest status of CDSCO directions has to be checked. We always advise to assess the latest status and related registration requirements with a competent partner. Gateway MedTech can support in this process.

Step 2:

Appoint an India Authorized Importer (IAI).

Manufacturers not having a local presence in India, must appoint an IAI or an India based distributor to manage the registration as well as post-market surveillance requirements. The IAI acts as a liaison between the India government (CDSCO) and the overseas manufacturer under the Drug Controller General of India (DCGI). The importer must hold a wholesale license and will receive authorization from the manufacturer to register the product and to regulate the import (license holder and importer) of the medical devices and IVD’s.

There can be several reasons to appoint an independent entity as IAI instead of a distributor. The main reason is that you can’t change the distributor for a period of 5 years once the importation certificate is issued on the distributor’s name. This could be a real issue in case of a non-performing distributor (the registration certificate can’t be transferred).

Step 3:

Submit the regulatory dossier

A list of documents must be compiled for registration. The required documents are similar to those required in other main jurisdictions. The most important documents are the Free Sale Certificate (FSC), ISO 13485, the quality manual and the technical dossier. See for further information our resources section.

Government fees apply for registration and the registration process can normally take in between 6 to 9 months.

Step 4:

Obtain registration certificate and import license

Once the documents have been submitted, the CDSCO will contact the IAI with a query letter. Based on the answers received, CDSCO will submit a second query letter or grant license. Once an approval has been granted by the CDSCO, it is unlimited in time. It does not have to be renewed. However, fees for the continuation of the license must be paid every 5 years. The local registration holder, or authorized domestic representative, is the only entity allowed to import the registered devices in India.

Step 5:

Market launch

Once the products have been launched in the Indian market, the authorized agent should report any change, adverse events, recalls in other countries or other relevant changes to CDSCO when they occur.

Temporary staffing solutions for registration and compliance

We know from experience that the India regulatory compliance journey for medical devices and IVD can be challenging. From concept to market it brings additional workload and requires specific expertise. Any manufacturer might struggle if current resources are not able to meet the deadlines and requirements. Our (temporary) staffing solution can support you in the regulatory process (registration and compliance) and will help you to meet project deadlines.

We offer a smart and quick solution meeting your budget to support you in your India registration and compliance process. We typically support with:

Document review preparation
Assistance for regulatory submissions
PMS and vigilance support
Compliance updates and alerts

With a team of experienced professionals, we have represented manufacturers from over 30 countries, directly handling over 10,000 medical device and diagnostic SKU’s.