Regulation of Medical Devices in India: Legal Information & International Perspective (Brief Comparison with US FDA & European Commission)
In this post, Pharmaceutical and Medical Device Lawyer Advocate Rahul Dev, discusses briefly about regulation of medical devices in India, relevant legal information, applicable laws and rules along with an international perspective and a brief comparison with U.S. FDA (United States Food and Drug Administration) and European Commission.
Generally, a medical device is an instrument, apparatus, implant, in vitro reagent, or other similar or related article, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body and which does not achieve any of its primary intended purposes through chemical action within or on the body. Whereas medicinal products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by other means like physical, mechanical, thermal, physico-chemical or chemical means. Medical devices include a wide range of products varying in complexity and application.
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. As per the latest list of regulated medica devices, issued on 20/04/2010, listed following devices to be considered as drugs under Section 3, Clause (b) Sub clause (iv) of the Drugs and Cosmetics Act: –
(a) Disposable Hypodermic Syringes
(b) Disposable Hypodermic Needles
(c) Disposable Perfusion Sets
(d) In vitro Diagnostic Devices for HIV, HBsAg and HCV
(e) Cardiac Stents
(g) Intra Ocular Lenses
(h) Drug Eluting Stents
(i) I. V. Cannulae
(j) Bone Cements
(k) Heart Valves
(l) Scalp Vein Set
(n) Internal Prosthetic Replacements
Additionally, the following products are regulated as ‘Drugs’ under Drugs & Cosmetics Act & Rules there under: –
(a) Blood Grouping Sera
(b) Ligatures, Sutures and Staplers
(c) Intra Uterine Devices (Cu-T)
(e) Tubal Rings
(f) Surgical Dressings
(g) Umbilical Cords
(h) Blood / Blood Component Bags
While the list of medical devices regulated in India is short, the US FDA regulates a wide range of medical devices, which include, Artificial Pancreas System, Baby Products with SIDS Prevention Claims, Breast Implants, Cochlear Implants, Computed Tomography (CT), Contact Lenses, External Defibrillators, Blood Glucose Monitoring Devices, Hearing Aids, Implantable Infusion Pump and Refill Kits, Urogynecologic Surgical Mesh Implants, Wrinkle Fillers, and the like.
Similarly, the European Commission legislates medical devices extensively, and rules relating to the safety and performance of medical devices were harmonised in the EU in the 1990s. The core legal framework consists of 3 directives: Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/EEC regarding medical devices and Directive 98/79/EC regarding in vitro diagnostic medical devices. They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These 3 main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC.
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