Gunjan Verma - India

“The recent updates to IVD classification in India gives us further insight into the rules governing IVD medical devices and may affect licensing for IVDs.”

Gunjan Verma
Managing Partner
Asia Actual India

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CDSCO Issues Updates to IVD Classification List in India

Published on: November 29th, 2023

The Central Drugs Standard Control Organisation (CDSCO) of India has issued a notice (PDF) on October 25, 2023, updating several in-vitro diagnostic (IVD) categories and classifications. The updates to IVD classification list in India include intended use, associated risk, additional IVD categories, and other parameters.

These updates mean that all medical devices, regardless of class, must either be registered in India through the ePortal (cdscomdonline.gov.in) or receive a Form MD-15 import license before importing.

We expect that these changes may affect the registration process for some medical device manufacturers, import license holders and distributors. Please contact an Asia Actual expert to learn more.

Updates to IVD Classification Lists

The notice advised that the CDSCO has updated two lists under the Medical Device Rules, 2017:

  • Annexure A for IVD analyzers – now contains 72 total medical devices
  • Annexure B for IVD instruments – now contains 29 medical devices, all of which are classified as class A (see below). This list also includes any other instrument not expressly stated in the list but intended for diagnostic purposes.

Two additional lists were also added to the Medical Device Rules, 2017:

  • Annexure D for IVD Specifmen Receptacles
  • Annexure E for products that are provisions of sub-rule (2) rule 4 of the Medical Devices Rules, 2017 (i.e. COVID, DNA, and mRNA Extraction Kits, etc).

There were no changes made to Annexure C which covers IVD software, although any software that drives a device or influences its use falls in the same class automatically.

The updates to the lists include changes to categories for some IVD devices; for instance, some items that were grouped together have now been split into two categories depending on whether they’re point-of-care or not.

IVD Classification in India

In order to determine whether a medical device requires a review or clinical test data to be registered in India, the CDCSO classifies them by type. Reviews in India can take six months or more for products classified Class A (m/s) and higher. Class A (non-m/s) only require an online registration and the local license holder will need to maintain certain documents in case the CDSCO requests them.

IVDs are separated into five classifications in India based on their risk-level, intended use and other parameters:

  • Class A (Non-Measuring/Sterile)
  • Class A (Measuring/Sterile)
  • Class B
  • Class C
  • Class D – High risk

IVD Grouping

IVDs can fall into a number of group categories, including:

  • Single
  • Family
  • IVD cluster
  • IVD test kit
  • System

These groupings allow license applicants to consolidate their medical devices into a category if they have the same intended purpose or share technological features as per the predefined criteria under Grouping guidelines to save time and money in applying. In this case, manufacturers or licensees can submit one application in India to streamline the process of regulatory compliance through a single Device Master File evaluation instead of multiple.

For more information on registering IVDs in India, please see our dedicated page on the topic here.

Learn More from Experts at Asia Actual

To better understand how the changes to IVD classification in India may affect your registered devices, get in touch with our experts at Asia Actual. We can guide you through the registration process and help you save time and money in certifying your IVDs in India.

Come Grow With Us

Please contact us if you’d like support from our experienced staff registering your device in India. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.

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