Regulation for medical devices

regulatory

1. REGULATION FOR MEDICAL DEVICES BY: BHAGYALAXMI RANAWAT SUBMITTED TO: TOSHA MA’AM

2. WHO REGULATES MEDICAL DEVICE • Australia - therapeutic goods administration (TGA) • Europe - certification is obtained from a notified body • USA - food and drug administration (FDA) • Canada - health canada • China - the state food and drug administration (SFDA) • Japan - ministry of health labour and welfare (MHLW) • Brazil - ANVISA • India - cdsco

3. FDA The food and drug administration (FDA or USFDA) is a federal agency of the united states department of health and human service.

4. Medical devices The term “medical devices” includes everything from highly sophisticated computerized medical equipment down to simple wooden tongue depressors . An instrument, apparatus, implement, machine, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which comes under the pharmacopeia. COMPUTERIZED MEDICAL EQUIPMENT -- x-ray machine, ECG machine, pacemaker etc.

5. CLASSIFICATION OF MEDICAL DEVICES

6. ESTABLISHMENT REGISTRATION AND DEVICE LISTING Establishments required to list their devices include: –Manufacturers –Contract manufacturers that commercially distribute the device –Contract sterilizers that commercially distribute the device – Repackagers and relabelers –Specification developers – Reprocessors of single-use devices –Remanufacturers –Manufacturers of accessories and components sold directly to the end user –U.S. Manufacturers of "export only" devices

7. Manufacturer must register their organisation with fda Submit electronically or through an US agent Verify registration every year (1 oct -31dec)

8. SIGNIFICANCE OF MEDICAL DEVICES The medical development in terms of drugs or devices has brought about the robust change in the life of the people. Medical devices have extended the ability of physicians to diagnose and treat diseases, making great contributions to health and quality of life . The capability of devices to enable patients to survive or just improve their quality of life. 

9. Medical devices in India are regulated under the medical device rules Published on 31st january 2017 Effective from 1st january 2018. The Indian medical regulatory system has become more complicated in recent years. In the past, medical devices did not need to be approved at all, but that is not the case today. In India, there are about 30 device “families” that outline which specific medical devices need to be registered.

10. REGULATION IN INDIA In India medical devices are governed by cdsco (central drugs standard control organization) which is regulated by directorate general of health services , ministry of health and family welfare , government of India. CDSCO is the only government body which regulate the medical devices

11.  No medical device regulations existed in india prior to 2005. However, today there are registration procedures for certain types of medical devices regulated under the medical device rules. The new rules are based on global harmonization task force . In India, the manufacturing, import, sale, and distribution of medical devices are regulated under India’s drugs & cosmetic act and rules (1945) . 22 medical devices are currently notified under the drugs and cosmetics act. Controls and inspections are carried out by the CDSCO, state drug controllers and central/state laboratories

12. PREMARKETED NOTIFICATION INTRODUCTION All medical devices must submit premarketed notification, except:- 1.Device for which PMA application is required 2.Device exempted from 510(K) notification FDA (most class I ). For device with 510(K) submission manufacturer must receive a clearance order before commercial distribution. It takes 90 days to receive clearance or longer typically 130 days ( depends on the information submitted by manufacturer)

13. It should demonstrate that the device to be marketed is as safe and effective as predicate. • After 510(k) approval the manufacturer can manufacture the device without waiting for fda quality system inspection, but submitter must be ready for inspection. Submitter must compare his medical device with similar legally marketed Device AND PROVE SUBSTANTIAL EQIVALANCE Submitter submits 510(K) to FDA before marketing and prove substantial equivalence Submitter receives an order in form of letter from FDA, which proves that the device is substantially equivalent.

14. SUBSTANTIAL EQUIVALENT A device is substantially equivalent only if 1.Same use as predicate and same technological characteristic as predicate. 2.Same use as predicate but different technological characteristic as predicate.

15. If FDA determines that the device is not substantially equivalent, the applicant may:- Resubmit another 510(K) Request class I and class II designation through de novo process File reclarification submission Submit a PMA application It confirms that safety and effectiveness are adversely effected by new technological characteristics.

16. WHEN IS 510(k) REQUIRED When a device is marketed for the 1st time, medical device that was not marketed before may 28,1976 for these devices 510(K) is required. Propose different use from that of the predicate. Change or modification in predicate medical device that affects the safety and effectiveness WHEN IS 510(k) NOT REQUIRED If unfinished product or components of devices are sold If distribute another firms device If device is marketed before may 28,1976 If device is from outside US and the exporter already submitted 510(k),then the importer need not submit the 510(K).

17. De novo classification Also known as automatic class III designation • For “low risk” devices with no predicate that are found to be NSE through the 510(k) process • Submitter must request de novo classification within 30 days of receipt of NSE • The de novo process has a 60 day review period. • If fda grants request the device is permitted to enter commercial distribution in same manner as 510(k) clearance • Device in DE novo can be used as a predicate in future 510(k) submission.

18. PRE MARKETED APPROVAL INTRODUCTION Mainly applicable for class III devices ( high risk) Applicable for class II if device is not substantially equivalent. Most stringent type of device marketing application FDA confirms pre marketed approval only when it confirms the scientific evidence to assure that the device is safe FDA requires 180 days to review or longer PMA- private license permitting the applicant to market the device FDA notifies applicant that PMA is approved or denied, the notice is published on internet also.

19. CONTENT OF PREMARKETED APPROVAL Device description and principle of operation Preclinical and clinical studies Bibliography of known information Manufacturing information Professional and patient labelling

20. POST MARKETING REQUIREMENT QUALITY SYSTEM REGULATION/GMP INTRODUCTION