Medical devices

medical devices

1. Presented By… Garima Saini M.Pharm. (DRA)(SEM-I ) Guided By… Dr. Vikaas budhwar Professor of Pharmaceutics MEDICAL DEVICES DEPARTMENT OF PHARMACEUTCAL SCIENCES

2. A MEDICAL DEVICE IS… “ Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals ”. As simple as a tongue depressor. As complex as robotic surgery devices.

3. MEDICAL DEVICES CLASSIFICATION Gloves , Bandages X-rays , Needles Pacemaker, Heart Valves By USFDA :

4. MEDICAL DEVICES CLASSIFICATION • Class A (Class-I)– Devices involving low risk levels (Thermometer) •Class B (Class-II a)– devices involving low to medium risk (Hypodermic Needle) •Class C (Class-II b)– Devices involving moderate to high risk (Lung ventilator) •Class D (Class-III)– Devices involving high risk. (Heart valve, implantable device) By CDSCO Risk Based classification:

5. GENERAL CONTROL regulating devices to ensure their safety and effectiveness. apply to all medical devices. include provisions that relate to : adulteration; misbranding ; device registration and listing ; premarket notification; etc

6. SPECIAL CONTROL regulatory requirements for class II devices. Special controls are usually device-specific and include : Performance standards Post market surveillance Patient registries Special labeling requirements Premarket data requirements Guidelines

7. PREMARKET APPROVAL(PMA) class III devices are subject to approval of a Premarket Approval Application (PMA ). Evaluate the safety and effectiveness of Class III medical devices Approval requires reasonable assurance of safety and effectiveness based on intended use Typically requires clinical data

8. PREMARKET NOTIFICATION (PMN or 510(k) ) Any Class I, II or III device intended for human use that does not require a PMA must submit a 510(k) demonstrates that the device is as safe and effective as a legally marketed device which is not subject to PMA This allows the FDA to decide whether the device is substantially equivalent to a legally marketed Class I or Class II device, or to a predicate Class III device not requiring a PMA

9. MEDICAL DEVICES RECLASSIFICATION Pre amendment Device Device in commercial distribution before May 28, 1976. Require a PMA only after FDA publishes a regulation calling for PMA submissions . initially classified as Class I, II, or III.

10. MEDICAL DEVICES RECLASSIFICATION Post amendment Devices : Devices that were not available on the market before the passage of the Medical Device Amendments of 1976 are generally referred to as post amendments devices. These are automatically classified into Class III, regardless of the risk they pose.

11. MEDICAL DEVICES RECLASSIFICATION Transitional Devices: Device that was regulated as a new drug before May 28, 1976. Any Class III device that was approved by a New Drug Application (NDA) is now governed by the PMA regulations . Some of the transitional devices were down-classified to Class II .

12. PHASES OF MEDICAL DEVICE CLINICAL TRIAL There are two main stages / phases: PILOT (FEASIBILITY) STUDY & PIVOTAL(CONFIRMATORY) STUDY

13. PILOT STUDY First done in humans, intended to acquire specific essential information about a device, before going to pivotal study. Exploratory in nature Use small number of patients (10-30 ) Meant to give insight into the performance & safety, but can’t provide definitive support to specific mechanism or therapeutic claims . Objectives include assessing feasibility (e.g. preliminary device performance),exploring eligibility criteria and their practical application for pivotal randomized controlled investigation, ascertaining potential harm(preliminary safety evaluations),validating a method for determining an outcome measure and evaluating the logistics of pivotal trial performance

14. PIVOTAL STUDY Definitive , confirmatory study. Conducted in a larger number of patients (100-300) to gather evidence for safety & efficacy For medical device which doesn’t have a predicate medical device but approved outside INDIA, pivotal studies need to be carried . Prior to conducting a pivotal clinical investigation in Indian subjects, Central Drugs Standard Control Organization (CDSCO) may require pilot study data generated in Indian population to assess whether the pilot data is in confirmatory to the data already generated outside the country

15. Post Marketing Clinical Investigation may not be considered necessary at the time of device approval but may be required by CDSCO for optimizing the intended use of medical device. It includes additional drug-device interaction, safety studies, investigation designed to support use under the approved condition( eg mortality/morbidity studies etc )

16. Regulatory Approval process for Manufacturing for Sale or Distribution #State Licensing Authority (SLA), Central Licensing Authority (CLA)

17. APPROVAL OF NEW MEDICAL DEVICES

18. REGULATION FOR IMPORT MEDICAL DEVICES Foreign and Indian companies will have to apply for permission to import medical devices in India. Both manufacturer and third party(agent) will have to register with CDSCO. Indian importer or agent –obtain ‘no objection certificate’. If the medical device is already approved by USFDA or CE -> Device registration in India will be trouble free. For the import of medical devices in India, Registration Certificate in Form 41 and Import License in Form 10 are required as per provisions of the Drugs & Cosmetic Act & Rules.

19. Procedure to Apply for Import of Medical Device

20. THANK YOU …