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REGULATORY
Year : 2010  |  Volume : 1  |  Issue : 3  |  Page : 90-93

Registration of medical devices


General Manager, Regulatory Affairs Reliance Life Sciences Pvt. Ltd

Correspondence Address:
Bobby George
General Manager, Regulatory Affairs Reliance Life Sciences Pvt. Ltd

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Source of Support: None, Conflict of Interest: None


PMID: 21814626

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Globally the medical device (MD) market has been growing quite rapidly over the past decade. The regulatory framework for pharmaceuticals and devices differ substantially. The regulatory authorities in different regions of the world recognize different classes of medical devices (MDs), based on their design complexity, their use characteristics, and their potential for harm, if misused. With the vast majority of MDs in developing countries being imported, the respective governments need to put in place policies & regulations to address all elements related to MDs, ranging from its development, manufacturing, registration to post-marketing obligations & disposal so that public can have access to high quality, safe & affordable products for appropriate use. This article highlights current regulations pertaining to registration of MDs in India, in light of those existing in Global Harmonization Task Force (GHTF) member countries & Association of Southeast Asian Nations (ASEAN) countries.


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