Medical Device Definition
A medical device in India means:
- Substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant
- Substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides
- Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals.
Medical Device Classification System
||Elastic bandages, Hot water bags, Sphygmomanometer.
||Low moderate risk
||Blood glucose monitoring devices, Nebulizers, Wheelchairs.
||Moderate high risk
||X-Ray machines, Infusion pumps, MRI machines.
||Heart valves, Implanted pacemakers, Artificial joints.
- Grant of License by SLA - 45 days
- Audit of the manufacturing site from the date of issue of license - 120 days
Class C and Class D:
- Audit of the manufacturing site from the date of application - 90 days
- Inspection report submitted to SLA - 30 days
- Grant of License by SLA - 20 days
- Completion of the scrutiny from the date of application - 45 days
- Audit of the manufacturing site from the date of application - 60 days
- Grant of License from the date of audit report - 45 days
|License validity period
||Does not expire if the license retention fee is paid (every 5 years)
||Class A or Class B:
Class C or Class D:
- One Site - 5000 INR
- Each Distinct Medical Device - 500 INR
- One Site - 50000 INR
- Each Distinct Medical Device - 1000 INR