NOTE FOR CENTER FOR MEDICAL DEVICES IN INDIA

1. NAME OF THE ORGANISATION & ITS STRUCTURE

The name of the center is to be provided. The society shall be registered under the
Societies Registration Act, Section 3 of the Act. The Memorandum of Association (MoU)
shall be created and filled with the Registrar of the Societies. The MoU shall contain the
name of the society, its address, its objects and purpose and the names, address ,its object
and purposes ,and the names, addresses and occupations of the member of the governing
body, by whatever name it may be called, duly signed for consent by all members
forming the society.
2. OBJECTS AND PURPOSE
The center can be a governmental or a non-governmental organization which can be used
as a platform to provide new opportunities in Medical Device Sector. To harmonize the
implementation of medical device regulations across the globe. It should provide
opportunities for domestic and foreign companies dealing with Medical Devices. It
should aim towards achieving harmonization in medical device nomenclature. It promote
a general understanding of medical device issues and their regulations. The use of
voluntary standards and their increasing prominence in medical device regulation
The main objective of this center is to create one exclusive regulation for Medical
Devices.
3. COMPOSITION
The minimum members required for the registration of a society are seven ( 7 ) according
to Section 20 of the Indian Societies Act, 1860.
4. ORGANISATIONAL STRUCTURE
The center shall constitute of a General Body consisting a minimum of seven members,
Executing Body/ Governing Body including the Board of Directors, President, VicePresident and other office bearers.
The establishment of a uniform certification format that will be used globally so that
different countries can certify that medical devices being exported comply with their
domestic regulatory requirements. This certification will help the importing countries to
regulate medical devices.

5. RULES AND REGULATION

It should be approved by the Central Licensing Approval Authority (CLAA)
All medical devices should be incompliance with the quality & safety standards

before selling.
It should adopt the regulatory standards of the Bureau Of Indian Standard(BIS) &
International Organization for Standardization(ISO) for quality management

system.
All medical devices imported in India are covered by Schedule M- III of the Drug

Technical Advisory Board (DTAB).

It should also comply with the rules and regulations of the Drugs and Cosmetics

Act, 1940
DISPUTE RESOLUTION