admin / 19th October, 2020

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

Regulation/Guidelines

Medical Device,

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Summary:

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

low risk -Class A
low moderate risk-Class B
moderate high risk-Class C
high risk-Class D

The Draft Notification for Non-Notified Medical Devices By CDSCO

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.

list of non notified medical devices In india

Let’s look at the list of non-notified medical devices and the total number of devices in each category.

SL No.	Categories of medical device	Total Number of Devices
1	Anaesthesiology	115
2	Pain Management	69
3	Cardiovascular	37
4	Dental	89
5	Ear, Nose, Throat (ENT)	78
6	Gastroenterological	163
7	Urological	90
8	General Hospital	72
9	Operation Theater (OT)	27
10	Respiratory	71
11	Neurological	131
12	Personnel use	24
13	Obstetrical and Gynaecological (OG)	116
14	Ophthalmic	144
15	Rehabilitation	48
16	Physical support	38
17	Interventional and Radiology	71
18	Rheumatology	11
19	Dermatology and Plastic Surgery	56
20	Paediatric and Neonatology Medical	137
21	Oncology	78
22	Radiotherapy	102
23	Nephrology and Renal care	39
24	Software	60

Categorization of IVD

Sl	No.	Categories	Total Number of Devices
1	IVD	Analyser	53
2	IVD	Instrument	18
3	IVD	Software	09

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.