Regulation/Guidelines

Classification Of Non-Notified Medical Devices : A Major Move By CDSCO

  • 19th October, 2020
Classification of non-notified Medical Devices : A major move by CDSCO

On 3rd September, 2020, CDSCO released a draft classification for non-notified Medical devices. The Ministry of Health and Family Welfare (MoHFW) is going to classify non-notified medical devices like gowns, adhesive drapes, and coveralls under Class A, and surgical drapes and non- notified in-vitro diagnostic (IVD) as Class B medical device. In February 2020, the MoHFW made a great move by releasing the medical device definition and inclusion of Chapter III A under MDR 2017. This led all importers and manufacturers to provisionally register these non-notified Medical devices with the CDSCO, effective from 1st April 2020. Upon registration, such non-notified Medical devices would enjoy exemptions from the Medical Device Rules’ remaining provisions, 2017 for a period 30 – 42 months (based on the Class of medical device). As per MDR-2017 Chapter II Rule (3), CDSCO the Central licensing authority for medical devices the classification of medical devices should be based on risk like

  1. low risk -Class A
  2. low moderate risk-Class B
  3. moderate high risk-Class C
  4. high risk-Class D

The Draft Notification

The medical devices are classified into 24 categories and are updated as per the international classification and First Schedule of MDR-2017.To facilitate the process of classification of all such medical devices including IVD medical devices, the devices are categorized like IVD analyser, IVD Instrument, and IVD software and examined as per the classification followed internationally and First Schedule of MDR-2017.

Let’s look at the Categorization of medical devices and the total number of devices in each category.

SL No.Categories of medical deviceTotal Number of Devices
1Anaesthesiology             115
2Pain Management             69
3Cardiovascular              37
4Dental                      89
5Ear, Nose, Throat (ENT)     78
6Gastroenterological         163
7Urological                  90
8General Hospital            72
9Operation Theater (OT)      27
10Respiratory                 71
11Neurological                131
12Personnel use               24
13Obstetrical and Gynaecological (OG)116
14Ophthalmic                  144
15Rehabilitation              48
16Physical support            38
17Interventional and Radiology71
18Rheumatology                11
19Dermatology and Plastic Surgery56
20Paediatric and Neonatology Medical137
21Oncology                    78
22Radiotherapy                102
23Nephrology and Renal care   39
24Software                    60

Categorization of IVD

SlNo.CategoriesTotal Number of Devices
1IVDAnalyser53
2IVDInstrument18
3IVDSoftware09

Key Highlights of the Notification

Earlier CDSCO only regulated 37 medical devices, the current notification seems to provide classification of non-notified medical devices which are falling under definition of medical device in coming times.

  • Spectacles (frames and lenses)
  • Contact lenses
  • Public respirator masks
  • Devices like Fertility, Diagnostic, Contraceptive, Software Application

Medical device companies should first assess whether their products fall within the list provided, and then make adequate arrangements with respect to the accompanying documents for the registration. Since these steps would have to be undertaken once the final Classifications are notified, companies would be well placed in keeping their documentation ready for the application.

Want to know more about the categories and number of devices in each category, you can click the link https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjQ0OQ==

If anyone has any objections or comments regarding the draft notification, they can send an email to cdsco.class.md@gmail.com within 30 days of the draft’s issuance.