India CDSCO introduced the Medical Device Rules (Medical Device Rules, 2017), Items subject to medical device registration have been expanded, and online applications for medical devices (SUGAM) have become mandatory.
In order to enter the Indian medical device market, it is essential to check whether registration is required and the product risk level through the classification table.
According to the introduced Medical Device Rules of India (Medical Device Rules, 2017), the list of items subject to medical device registration is classified into 24 categories, and the detailed products for each product group are briefly listed below.
| Sr.No. | Categories of Medical Device | MEDICAL DEVICE NAME (example) |
| 1 | Anesthesiology | Aerosol delivery tubing, Anesthesia machine, Airway tube forceps, In-line backflow valve, Endobronchial airway sizing kit etc. |
| 2 | Pain Management | Heat therapy gel, Foot bath, Ice collar, Ice bag, Sitz bath chair, Static magnetic bed mattress overlay, Static magnetic massager etc. |
| 3 | Cardiovascular | Echocardiograph, Vascular clip, Pacing system analyzer, Pacemaker lead adaptor, Pacemaker service tools etc. |
| 4 | Dental | Dental collar/crown scissors, Basic electric toothbrush, dental impression material, Dental anaesthesia syringe etc. |
| 5 | Ear, Nose, Throat (ENT) | Audiometer testing system, ENT chair, Ossicular prosthesis, Hearing aid calibrator etc. |
| 6 | Gastroenterological | Catheter, Colonic lavage kit, Endoscopic biopsy valve, Flexible ultrasound duodenoscope, Proctoscope, Robotic electrosurgical instrument etc. |
| 7 | Urological | Cystometer, fibreoptic cystourethroscope, Flexible video urethroscope, Incontinence sensor/alarm, Ureteral patency kit etc. |
| 8 | General Hospital | Clinical electronic thermometer, Pediatric medical crib, Hydraulic adjustable hospital bed, General purpose disinfectants, Medical washer-disinfector etc. |
| 9 | Operation Theater (OT) | Operation table system, Suction system portable, Electrical/Pneumatic, Surgical light system etc. |
| 10 | Respiratory | Bulk oxygen concentration system, Diagnostic spirometer, Airway tube forceps, Monitoring spirometer, Stress test treadmill etc. |
| 11 | Neurological | Analytical scalp electrode, Atrial cerebrospinal fluid catheter, Deep brain electrical stimulation system, Echoencephalograph etc. |
| 12 | Personnel use | Latex surgical glove, Radiation protection cap, Medical/Cadaver Body Bags, Radiation protection goggles etc. |
| 13 | Obstetrical and Gynecological (OG) | Abortion suction system manual aspirator, Endometrial biopsy kit, Foetal stethoscope, Massage oil/cream/gel etc. |
| 14 | Ophthalmic | Contact lens protein-removal solution, Diagnostic condensing lens, Eye heat therapy pack etc. |
| 15 | Rehabilitation | Acupressure calf band, Bed/chair electric massager, Cold/cool therapy gel, Electric massager, Telemetric diagnostic spirometer etc. |
| 16 | Physical support | Bed traction frame, Finger orthosis, Knee immobilizer, Physical therapy massager etc. |
| 17 | Interventional and Radiology | Bone densitometer, Diagnostic ultrasonic transducer, Mammographic x-ray system etc. |
| 18 | Rheumatology | Canes, Grab bars in showers and tubs, orthopaedic shoes etc. |
| 19 | Dermatology and Plastic Surgery | Surgical camera and accessories, Colonoscope, General & Plastic Surgery, General electrosurgical unit, Laser surgical instrument for use in general and plastic surgery and in dermatology etc. |
| 20 | Pediatric and Neonatology Medical | Airway Pressure / Oxygen Monitor, Craniofacial bone screw, Infant incubator control unit etc. |
| 21 | Oncology | Antimicrobial postsurgical brassiere, Brachytherapy system chair etc. |
| 22 | Radiotherapy | Absorbable tissue spacer for radiotherapy, Living tissue radiotherapy system, X-ray radiation therapy system etc. |
| 23 | Nephrology and Renal care | Automated peritoneal dialysis system, Haemofilters etc. |
| 24 | Software | Insulin Pump Secondary Display, Electrocardiograph Software for home use, Diagnostic supporting software for diabetes etc. |
Please refer to the file below for Detailed classification.
Additionally, the information required when applying for medical device registration in India is
briefly outlined below:
- Importer company (organization) name
- Product details (model name, serial number, purpose of use, life expectancy, method of use, etc.)
- Label
- ISO13485
- Free Sale Certificate, FSC
However, please note that a local representative is essential for medical devices registration in India.
If you have any questions about medical device in India,
Please contact us with the below.
info@jnmglobal.net
ra@jnmglobal.net