India Medical Equipment registration and importation process updates

Question: How can a Medical Device Import License be obtained?

The Medical Device import license can be obtained by filling Form MD-14 and submitting to

the CDSCO. An authorized Indian agent must be appointed for the same.

Question: What are important aspects when preparing and submitting form MD-14?

• Creating a Device Master File (DMF) using a technical file from another GHTF (Global

  Harmonization Task Force) country can reduce the time required for registration. The

  time required to create a DMF depends on the completeness of the documents

  provided but normally it takes only a few days.

• A FSC (Free Sale Certificate) from the country of origin is required to register a

  medical device in India. If you are from a non-GHTF country, a Free Sale Certificate

  from either USA, EU, Canada, Australia or Japan is recommended to expedite the

  approval process with minimal queries from the CDSCO.

• As per India MDR 2017, the CDSCO may inspect the manufacturing site either by itself

  or a third party body. The fee and the expenditure for the same will be borne by the

  manufacturer. However, in our experience of working with the CDSCO for medical

  devices for more than 15 years, no audits of the legal or actual manufacturer have

  been conducted. A valid ISO 13485 certificate from the manufacturer factory and a

  Plant Master File (PMF) are considered sufficient for compliance.

• A Plant Master File (PMF) is based on a Quality Manual and is a straightforward

  document. Once all relevant documents are provided, the Plant Master File can be

  created within a few working days.

Question: Can you start selling without a Medical Device License in India?

The manufacturer needs to obtain the Import License (Form MD-15) to start selling in India.

An Indian Agent needs to be appointed who can apply on behalf of the manufacturer in

India.

Question : What is the validity period of a medical device import license Form MD-15 in

India?

In India, a medical device license is valid for perpetuity unless its cancelled or surrendered.

However, it is essential to renew the license every five years by depositing a license

retention fee to ensure continued compliance with regulatory requirements. A late fee of

two per cent will be applicable if the due date is crossed.

As per the current regulations, it is mandatory to pay the government fees every five years

and provide retention documents like renewed certificates, any changes made to the device

or manufacturing site over the last 5 years, any reported recalls or adverse events in India.

Importers need to ensure all documentation, including application forms, sales data, and

post-market reports is up-to-date so that during renewal, no changes are there to report.

The renewal process does not allow the importer to include any changes to the product.

Importers need to submit a declaration that there has been no change since the product is

registered or accompany the registration with the post approval changes (see comments

below on post-approval medical device changes).

Question: How is grouping of devices determined in India?

In India, medical devices are grouped into four categories - single, family, system and group.

The grouping is determined based on the intended use, device design and manufacturing,

material of construction, device risk classification and how it is sold (individual or packaged):

1. Single Grouping: Devices like condoms, requiring distinct licenses and documentation

   for different package sizes.

2. Family Grouping: Groups similar devices, such as defibrillators and gloves, under a

   single license to simplify compliance.

3. System Grouping: Products designed to function together, like hip replacement

   systems, are grouped together; separate components need individual

   documentation.

4. Group Category: Devices from various manufacturers, like those in first aid kits, share

   fee structures but require separate documentation.

Question: What are the government registration fees for different classes of medical

devices in India?

Notified
Class	Fee	US$
Class A	(A) One site; and	$1000
	(B) Each distinct medical device	$50
Class B	(A) One site; and	$2000
	(B) Each distinct medical device	$1000
Class C & Class D	(A) One site; and	$3000
	(B) Each distinct medical device	$1500

Question: What are medical device labelling requirements in India?

Labelling regulations under the Legal Metrology Act, 2009, and the Medical Devices Rules,

2017, are one of the significant requirements for Medical Device Manufactures exporting to

India. If a license is approved in another country, the same label design can be registered in

India, provided that the details of the country of origin and the India importer details are

included on the label along with all the requirements as listed in Chapter VI of the India

Medical Device Rules 2017. Some specific comments:

1. Labelling guidelines: The label has to include information like device name,

   manufacturer details, batch numbers, and instructions for proper use, ensuring

   compliance and safety, etc.

2. Maximum Retail Price (MRP): The Legal Metrology Act, 2009 requires medical device

   importers to ensure that the Maximum Retail Price (MRP) is indicated along with theimporter details and license number.

3. Labelling Standards: Mandates manufacturer details, product info, net quantity,

   dates, prices, indelible ink, batch numbers, expiry, storage, etc.

Question: What is the procedure in India in case of post-approval medical device changes?

Modifications to medical products after CDSCO approval, such as changes in design,

intended use, material etcetera, need to be updated to the CDSCO. Changes are classified by

the CDSCO under the Drugs and Cosmetics Rules as either major or minor changes

1. Major Changes: Involving significant impact on device specifications, these changes

   require prior approval and include updates to materials, design, sterilization, and

   more. They must be implemented within 60 days.

2. Minor Changes: Affecting the device minimally, these do not need prior approval but

   must be reported within 30 days to become effective.

To manage post-approval changes with the CDSCO, an Indian importer must prepare

documentation, submit it, pay fees, undergo a review, and receive updated approval, with

ongoing compliance monitoring.

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