Classification of Non - Notified Medical Devices and IVDs in India - Decode CDSCO’s New Notices

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.