Classification of Non - Notified Medical Devices and IVDs in India - Decode CDSCO’s New Notices | Freyr - Global Regulatory Solutions and Services Company

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Central Drugs Standard Control Organisation (CDSCO), the authority regulating Medical Devices in India has released two new notices on September 3, 2020, which include the classification of non-notified medical devices and in-vitro diagnostic devices (IVDs).

The new notices facilitate manufacturers to classify the medical devices and IVDs into appropriate device class and to map the effective dates for respective device registration. All the medical devices are expected to be regulated by the CDSCO in a phase-wise manner and they are required to be registered within the specified timelines.

As per the new notices, CDSCO has classified around 1866 medical devices and 80 IVDs. At a high level, the medical devices are categorized into 24 categories and the IVDs are categorized into three (3) categories.

*Product Category*	*Device Category*	*No.*	*Total No.*
Medical Device	Anesthesiology	115	*1866*
Medical Device	Pain Management	69
Medical Device	Cardiovascular	37
Medical Device	Dental	89
Medical Device	Ear, Nose, Throat (ENT)	78
Medical Device	Gastroenterological	163
Medical Device	Urological	90
Medical Device	General Hospital	72
Medical Device	Operation Theater (OT)	27
Medical Device	Respiratory	71
Medical Device	Neurological	131
Medical Device	Personnel Use	24
Medical Device	Obstetrical and Gynecological (OG)	116
Medical Device	Ophthalmic	144
Medical Device	Rehabilitation	48
Medical Device	Physical Support	38
Medical Device	Interventional and Radiology	71
Medical Device	Rheumatology	11
Medical Device	Dermatology and Plastic Surgery	56
Medical Device	Pediatric and Neonatology Medical	137
Medical Device	Oncology	78
Medical Device	Radiotherapy	102
Medical Device	Nephrology and Renal care	39
Medical Device	Software	60
IVD	IVD Analyzer	53	80
IVD	IVD Instrument	18
IVD	IVD Software	9
*Total No. of Non-Notified Devices Classified Under New Notices*			*1946*

All the devices listed above are examined and categorized as per internationally acceptable classification and First Schedule of Medical Device Rules, 2017. The list provided below comprises a detailed summary of medical devices classified into different risk classes.

*Risk Classification*	*Medical Devices*	*IVDs*	*Examples*
Class A	485	12	Airway protection face mask, Microbial incubator/imaging, Bar dental precision attachment, Back/leg/chest dynamometer
Class B	779	38	Telemetric diagnostic spirometer, Liposuction catheter, Reactive-gel heating pad, Microarray Analyzer, Faecal occult, Blood immunoassay analyzer
Class C	506	28	Oxygen breath analyser, General electrosurgical unit, Symblepharon ring, Contraceptive spermicide, Cancer risk assessment interpretive software
Class D	83	2	Nucleic acid amplification (PCR) analyser, ABO/Rh(D) blood grouping analyser, Intracranial pressure monitor device, Pacemaker repair or replacement material, Foetal cardiac monitor

All the low-risk Class A and moderate low-risk Class B devices must be registered with the CDSCO by August 2022, and all the moderate high-risk Class C and high-risk Class D devices have to be registered by August 2023.

As of now, with respect to the new notices, the CDSCO is open to receive comments from all the stakeholders of medical device industry, such as, manufacturers and associations. The industry can comment till October 3, 2020. To adopt and comply with the new CDSCO regulations, the medical device and IVD manufacturers are advised to consult a regional Regulatory expert.

Would you like to gain more insights on medical devices and IVD’s regulations in India? Know more about regulations, registration pathways, and proven cases of classification. Stay informed. Stay compliant.