Regulating & Licensing of

Medical Devices in India

By: Neelesh Bhandari LLM(M&HL)

Law Relating to Commissioning of
Hospitals Enrolment no. A3268821002
Introduction

A medical device is any device intended to

be used for medical purposes while using
the medical devices it must be proved safe
and effective. A reasonable assurance
before regulating governments allow
marketing of the device in their country.
Examples of Medical Devices
Definition of medical Device
At present medical devices are regulated
as ‘Drugs’ ,Under the Drugs and
Cosmetics Act 1940 and Rules made there
under in 1945.
 (a) “ drug” includes all medicines intended for internal or
external use for or in the diagnosis, treatment, mitigation or
prevention [disease or disorder in human beings or animals,
and manufactured] exclusively in accordance with the
formulae described in, the authoritative books of Ayurvedic,
Siddha and Unani Tibb system of medicine, specified in the
First Schedule;
Regulation of Medical Devices
Regulatory Authority
The Drugs & Cosmetics Act, 1940 and rules
1945 have entrusted various responsibilities
to central & state regulators for regulation of
drugs & cosmetics.
The authority regulating medical devices is
Central Drug Standard Control Organization
(CDSCO) under Directorate General of Health
Services, Ministry of Health & Family Welfare,
Government of India
 CDSCO Responsibilities
•Approval of Drugs,
•Conduct of Clinical Trials,
• Laying down the standards for Drugs,
• Control over the quality of imported Drugs in the country,
• Coordination of the activities of State Drug Control
Organizations by providing expert advice,
• Bringing uniformity in the enforcement of the Drugs and
Cosmetics Act on state regulators.
• CDSCO along with state regulators is jointly responsible for
grant of licenses of certain specialized categories of critical
Drugs such as blood and blood products, I. V. Fluids, Vaccine
and Sera.
Process of licensing
Thank You