The Indian medical devices industry forms an integral section of the healthcare industry. It is the fourth largest in Asia and one of the top twenty in the world in terms of market size. Medical Devices Rules 2017, are the new set of rules separating medical device industry from the pharmaceutical sector. On January 31, 2017, the Ministry of health and Family Welfare notified the Medical Devices Rules 2017 under the Drugs and Cosmetics Act 1940. The new Rules have been framed in conformity with Global Harmonisation Task Force (GHTF) framework. The rules simplify the process of introducing new medical devices to the Indian market while setting norms for ensuring high-quality devices for patient care and safety. The rules will be effective on January 1, 2018. New medical device policy, therefore, would also help in categorization of medical devices into different types – capital equipment, implants, consumables, in-vitro diagnostics and hence further facilitate the process of regulating them and help manufacturers to innovate for price competitiveness.
The first step is to identify the substances that fall within the ambit of the term medical device under the Medical Device Rules, 2017. The rules distinguish drugs from medical devices and eliminate regulatory ambiguities on what constitutes a medical device. The term medical device has been defined under the Rules of 2017 and includes specific devices that help in diagnosis and treatment, specific substances that affect the human body, surgical dressings, bandages, blood collection bags etc. or any other substance or device used in diagnosis or treatment of any disease or disorder of any human being or an animal. These devices and substances defined under the rules will be notified by the government from time to time.
One needs to note that the Drug and Cosmetic Act, 1940 defines ‘drug’ and this definition contains the term medical devices. Thus, the Drug and Cosmetic Rules, 1945 will continue to govern the manufacture of medical devices. Though many may consider this as a hindrance, the government seems to have thought through the possibility of conflict or overriding effect and has provided for a clarification in the Medical Rules 2017, which states that, in the event of any conflict between the Drug and Cosmetic Rule 1945 and Medical Devices Rules 2017, the Medical Devices Rules 2017, shall have effect.
Under previous rules of 2016 there was no classification given to medical devices. The new rules of 2017 will introduce a risk based classification system for regulation of medical devises. Low Risk (Class A), Low Moderate Risk (Class B), Moderate High risk (Class C) and High Risk (Class D). Unlike other countries, manufacturers/ importers have no liberty to classify their product for registration under new Rules, 2017. The classification shall be made by DCGI, which would be published on official website of DCGI. The classification once done by DCGI is non-appealable.
The Rules bring major changes in licensing. It will be for the first time that there will be no requirement of periodic renewal of licences. The process of granting license under the Act would process through online electronic platform. A license or a loan license, once granted would remain in perpetuity, subject to payment of requisite fees. However the license granted can be cancelled or suspended, wholly or partly by the Licensing Authority if it contravenes the Drugs and Cosmetics Act or Medical Device Rules or fails to pay the requisite fee of the license. Manufacturers must apply to the Central Licensing Authority for a license to manufacture a small number of devices for the purpose of clinical investigations, test, evaluation, examination, demonstration or training. The application form must be accompanied with appropriate documents which contain brief description of the medical device including the intended use, material used, the design and an undertaking (along with details of) stating that the requirement with respect to facilities including equipment, instruments and personnel have been provided for manufacturing the device. The test license has three-year validity. Imported device forms an important part of medical device industry. In order to distribute the medical devices, the applicant must be an authorised agent to having a license issued by Licensing Authority to distribute and sale under Medical Device Rules.
As per the Rules, the manufacturer must follow the essential principles of safety and performance of medical devices. The product standards applicable would be laid down by the Bureau of Indian Standards or as may be notified by the Ministry of Health and Family Welfare for the relevant medical device/s. In absence thereof, standards laid down by the International Organisation for Standardisation or the International Electro Technical Commission (IEC). This provision ensures that all medical devices produced in India are of a certain standard. These standards serve as a quality assurance stamp, which provides a feeling of wellbeing to the consumers. It also boosts the position of the Indian medical devices industry globally, as quality was a known issue with products that are manufactured in India.
The Medical Devices Rules 2017 has provided for labelling of the products to be undertaken by the manufacturers. The Medical Devices Rules 2017 states that every applicant/ manufacturers should provide –
Apart from a test license permission from the Central Licensing Authority must also be obtained to actually conduct clinical investigations. The conduct of clinical investigations or trials, according to the Medical Devices Rules 2017 must be carried out with a twin objective, i.e. to protect and uplift patient welfare and safety and must be carried with an intention to invent a new medical device. For purely academic clinical studies on licensed medical devices the prior approval of the Central Licensing Authority is not required; it must only be duly approved by the Ethics Committee constituted by the institution.
Earlier, the shelf life of a medical device manufactured in India cannot be for more than 60 months unless a justification to the contrary is presented. While this was the case under the Drugs Rules as well, the Devices Rules has eased the residual shelf life requirement for imported devices. Under the Drugs Rules, all imported devices should have had a minimum shelf life of 60% from the date of import. The D&C Rules prescribe that all imported products should have a minimum residual shelf life of sixty (60) percent on the date of import unless specific permission is obtained to the contrary. The Medical Devices Rules 2017 has envisaged new threshold for shelf lives of the products.
The medical device rules will provide a conducive environment for fostering Indiaspecific innovation and improving the accessibility and affordability of medical devices across the globe by leveraging a comparative cost advantage of manufacturing in India. The objective, transparent and predictable regulatory framework will boost the confidence of investors and, as a consequence, the quality and range of products and services will improve and business burdens will be reduced. Furthermore, the Rules will increase the visibility of the Indian medical devices on the global market radar and not only increase the sales of Indian devices but also attract more FDI. There is no doubt that the fact of notification of the 2017 Rules and the very real possibility of it coming into effect in 2018 should be celebrated!
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