On February 2, 2017 The Ministry of Health and Family Welfare has announced Medical Devices Rules, 2017 that separates regulatory norms for manufacturing medical devices from drugs. The rules will come into effect from January 1, 2018.
This new rules is to regulate medical devices in the country to ease norms for manufacturing medical devices in the country and to promote domestic industry. The new rules also have eased standard for obtaining license and conducting clinical trials, and also reduced interface between manufacturer and regulator by promoting digital platform.
The government has observed to the industry’s nearly decade long demand of separating it from pharmaceutical industry so that the same powerful laws that regulate drugs are not applicable to medical devices. The rules have a provision for awarding compensation up to ₹8 lakh to people impacted by trials adversely.
The Health Ministry joint secretary KL Sharma said, “Till now medical devices were regulated as drugs but now we have separated the two and formed rules specifically catering to the medical devices industry,” Medical devices have been classified in four categories based on their risk type (Class A, B, C and D). Central government will be directly involved in approvals and licensing of devices falling under category C & D.
The industry will no longer have to follow tough clinical trial guidelines spanning 4 phases, like in case of drug trials. Only a pilot study on smaller population to test safety and performance of the device and later a trial on pivotal basis on a larger population, The rules are designed to standardize and regulate medical devices manufacturing industry, as good as international standards. The new rules have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and follow best international practices.
The action will boost government’s ‘Make in India’ campaign by providing favorable environment for domestic manufacturers that could lead to greater long term investments.
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