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 to8 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.

HindustanTimes

Other News

Indian Govt Notifies New Norms to Regulate Medical Devices

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 […]

Read More

Maharashtra FDA Asks Blood Banks to Submit License Renewal Applications

Maharashtra Food and Drug Administration (FDA) has directed all 306 blood banks in the state to submit applications of renewal of licenses by 31st December 2016 to carry out timely inspections and approvals. There are […]

Read More

Indian Syringe and Needle Market 2015-2020

Indian syringes and needles market is expected to grow at a CAGR of 15% by 2020. This growth is mainly because of India’s large pool of patients, increase in healthcare expenditure, increase in healthcare awareness […]

Read More

FSSAI Drafts Safety Regulations for Nutraceuticals & Food Supplements

The Ministry of Health’s Food Safety Standards Authority of India has come out with quality and safety standards to regulate the standards and quality of health supplements, nutraceuticals, food (special dietary care, medicinal purpose, functional […]

Read More

FSSAI Proposes New Rules for Health Supplement misabelling

On Monday, Indian food safety watchdog the Food Safety and Standards Authority of India (FSSAI) announced that health supplements cannot be sold as medicines at all and also fixed the permissible limits of various ingredients […]

Read More

More Than Half of Women Plan to Buy Natural Beauty Products

Now a new survey shows that, natural products continue to remain top of mind for many women when it comes to the personal care beauty products. The second annual Green Beauty Barometer survey questioned more […]

Read More

Korean Entrepreneurs to Venture into Indian Cosmetics Market

The United States remains the biggest market for Korean cosmetic products and nowadays Korean investors are venturing into Indian cosmetic market. The Korea Trade Investment Promotion Agency (KOTRA) launched at least 10 Korean cosmetics brands […]

Read More

Meet Us at The Medical Device Regulatory Summit in Mumbai

The first Medical Device Regulatory Summit in India is being held at Holiday Inn Mumbai International Airport on 29 November 2016. Morulaa HealthTech is pleased to partner at this event. Medical Device Regulatory Summit 2016, […]

Read More