DRUGS AND MEDICAL DEVICES REGULATONS IN INDIA

Transcript:DRUGS AND MEDICAL DEVICES REGULATONS IN INDIA:
DRUGS AND MEDICAL DEVICES REGULATONS IN INDIA MEDICAL DEVICES RULES 2017 EFFECTIVE FROM IST JANUARY 2018 20-04-2023 HARNA 1 MEDICAL DEVICE A MEDICAL DEVICE IS DEVICE USED IN CURE MITIGATION TREATMENT, PREVENTION AND DIAGNOSIS OF DISEASES IN HUMAN BEINGS AND ANIMAL, BY NOTIFICATION UNDER SECTION 3 OF THE DRUGSA AND COSMETICS ACT AND MEDICAL DEVICES RULES 2017 THE MEDICAL DEVICE IS A MULTI-PRODUCT SECTOR, WITH THE FOLLOWING BROAD CLASSIFICATIONS: (A) ELECTRONICS EQUIPMENT; (B) IMPLANTS; (C) CONSUMABLES AND DISPOSABLES; (D) IVD REAGENTS; AND (E) SURGICAL INSTRUMENTS. 20-04-2023 HARNA 2 STATUTE 20-04-2023 HARNA 3 DRUGS AND COSMETICS ACT 1940 AND RULES THERE UNDER DRUGS ACT 1940 + DRUG RULES MEDICAL DEVICES RULES 2017 COSMETICS RULES 2020 MARKET SIZE National Medical Device Policy, 2022 THE CURRENT MARKET SIZE OF THE MEDICAL DEVICES SECTOR IN INDIA IS ESTIMATED TO BE $11 bn AND ITS GLOBAL MARKET SHARE IS ESTIMATED TO BE 1.5% . INDIA IS COUNTED AMONGST TOP 20 GLOBAL MARKET OF MEDICAL DEVICES, AND 4TH LARGEST MEDICAL DEVICES MARKET IN ASIA AFTER JAPAN, CHINA, AND SOUTH KOREA 20-04-2023 HARNA 4 INDIAN MEDICAL DEVICE MARKET COMPOUND ANNUAL GROWTH RATE 20-04-2023 HARNA 5 MEDICAL DEVICES RULES 2017 DEFINITION OF MEDICAL DEVICES::devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) APPLICATION: These rules shall be applicable in respect of,- (i) 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 covered under sub- clause (i); (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); AND as defined under section 3(b)(iv) of the Drugs and Cosmetics Act 1940 20-04-2023 HARNA 6 NOTIFICATION OF MEDICAL DEVICE MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 11th February, 2020 S.O. 648(E).— In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings or animals as drugs with effect from the 1st day of April, 2020, namely:― All devices including an instrument, apparatus, appliance, implant, material or other article, ……..ans, but which may assist in its intended function by such means