Registration of medical devices

• Published in: Perspectives in clinical research Vol. 1; no. 3; pp. 90 - 93
• Main Author: George, Bobby
• Format: Journal Article
• Language: English
• Published: India Medknow Publications and Media Pvt. Ltd 01.07.2010; Medknow Publications Pvt Ltd; Wolters Kluwer Medknow Publications
• Subjects: International trade; Laws, regulations and rules; Medical device; Medical equipment; Medical equipment and supplies industry; Medical test kit industry; Physiological apparatus; Registration; Regulations; Regulatory; India; Regulations; Registration; Medical device
• ISSN: 2229-3485; 2229-5488
• DOI: 10.4103/2229-3485.71862

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.