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GOI Classifies Some Medical Devices as Drugs

<br>The Ministry of Health and Family Welfare, GOI recently released a draft notification concerning the classification of certain medical devices as drugs. The draft was released in October, 2019 and suggestions were invited from the public and stakeholders for finalizing it as a new addition to the Medical Device Rules, 2017.

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GOI Classifies Some Medical Devices as Drugs

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  1. GOI Classifies Some Medical Devices as Drugs The Ministry of Health and Family Welfare, GOI recently released a draft notification concerning the classification of certain medical devices as drugs. The draft was released in October, 2019 and suggestions were invited from the public and stakeholders for finalizing it as a new addition to the Medical Device Rules, 2017. The government proposed to notify all devices under sub- Contact No: +91 7672005050 Email: contact@cliniexperts.com

  2. section (b) of section 3 of the Drugs and Cosmetics Act, 1940 to regulate them as per the provisions of the said act and Medical Device Rules, 2017 framed there under. These new amends have come into effect from December 1, 2019. According to this new addition, the GOI has specified certain devices intended for use in human beings and animals as drugs. In more detailed terms, all devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, using a software or an accessory. Intended for internal or external use on human or animal body for medical purposes will now be considered as drugs. These devices should not achieve the primary intended medical action using pharmacological or immunological or metabolic means. But can assist in such means. These medical devices can be used for: ●Diagnosis, prevention, monitoring, treatment, assistance or alleviation of any disease, disorder, injury or disability ●Investigation, replacement, modification or support of the anatomy or of a psychological process Contact No: +91 7672005050 Email: contact@cliniexperts.com

  3. ●Supporting or sustaining life ●Disinfection of medical devices ●Control of conception These devices were earlier regulated only by the Drugs and Cosmetics Act 1940, which is not a comprehensive set of rules to monitor drugs according to the current Indian and global perspective. Since the government formulated the Medical Device Regulation India Rules in 2017, and implemented in 2018. The classification, registration and other functions associated with the drugs and medical devices has been properly upgraded to conform with the best and global standards. This new step will obviously make some changes to the existing classification and registration procedures of some medical devices. So it is better to seek the help of an expert licensed medical device registration consultant in India. Contact No: +91 7672005050 Email: contact@cliniexperts.com

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