The Central Drug Standard Control Organization (CDSCO) in the Ministry of Health & family Welfare is primarily responsible for the regulation of drugs, medical devices, diagnostic devices and cosmetics.  Currently India has no specific regulations for medical devices. They are freely imported into India, except for implantable devices, critical diagnostic kits and sterile devices, which are required to be registered. Sterile medical devices are considered to be drugs and Medical devices defined as drugs require a registration certificate and an import license before being sold in the market.
 
The regulations for the manufacturing of Medical Devices is defined in Schedule M III and a new set of regulations for medical devices, known as Revised Schedule M-III, has not been formally announced by the Health Ministry. Under the new Schedule, M-III will place regulatory requirements on medical devices according to their classifications.  Under Revised Schedule M-III, medical devices are divided into four classes according to their risk level--A, B, C and D. Since there has been other initiative and proposed bills for the regulation of medical devices in India, we currently cannot anticipate when and if the Revised Schedule M-III will come into effect. Our country specific (*) regulatory services in India include:
 
Medical Device specific regulation strategy reports, Medical Device Registration with India MOH, India MOH Technical documents Preparation, India license holder and local Authorized Representative and Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.
 
GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™
 
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(*) Indian Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.