Royzz & Co
Medical Devices Amendment Rules
Indian medical device market is growing and it is expected to reach a valuation of INR 794.29 billion by 2023. Key growth factors for the development of medical device market in India are combined efforts of the Government and private sectors to improvise healthcare industries and change in India’s Foreign Direct Investment policy. There were no medical device regulations in India prior to 2005. However, today the Government regulates certain medical devices under the Medical Device Rules.
On February 11, 2020 Central Government notified that all medical devices will be treated as ‘drugs’. This notification will be effective from April 1, 2020. The quality and safety standards of all medical devices are regulated under ‘Drugs and Cosmetics Act’. The Government notified the Medical Device (Amendement) Rules, 2020 and new definition of medical devices under it is reproduced below:
“All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ― (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life; (v) disinfection of medical devices; and (vi) control of conception”
The Medical Device Rules (hereinafter ‘The Rules’) have been framed under the Drugs and Cosmetics Act, 1940 (hereinafter ‘The Act’). Until February 11, 2020 only 37 notified medical devices were regulated by the Government. However, after the notification on February 11, 2020 all the medical devices described by the above definition, will be regulated under the Act. The Government has moved a step forward in the direction of implementing quality standards requirement. All the medical devices imported or manufactured in India should be compliant with ISO 13485 standards and registration for these devices has to be obtained from Central Drugs Standard Control Organisation (CDSCO) through a dedicated online portal ‘Online Systems for Medical Devices’. ISO 13485 is a standard laid down by International Organization for Standardization for companies or organizations which are engaged in design, installation, production and servicing of medical devices However, the 37 categories of already regulated medical devices are exempted from obtaining the registration. Even though the 37 categories of notified medical devices are exempted from registration the importers, manufacturers, distributors, whole sellers and retailers will have to obtain licenses from appropriate licensing authority.
Medical devices are classified under for categories as mentioned below:
Class A – Low Risk (For e.g.: Stethoscope)
Class B – Low-moderate Risk (for e.g. Hypodermic needles)
Class C – Moderate-high risk (For e.g.: Bone fixation)
Class D – High Risk (For e.g.: Stents)
Government has laid down different deadlines for compliance with the licensing and registration requirements for different classes of medical devices, the deadlines are as follows:
All unregulated medical devices must be registered by the respective importers or manufacturers before October 1, 2021.
All stakeholders involved in import, production, distribution, and sale of presently unregulated Class A and Class B medical devices must obtain a license from appropriate licensing authority before August 11, 2022.
All stakeholders involved in import, production, distribution, and sale of presently unregulated Class C and Class D medical devices must obtain a license from appropriate licensing authority before August 11, 2023.
The Government has provided the above mentioned window so that the manufacturers and importers get enough time to get their facilities certified as compliant with ISO-13485.
It is important to note the difference between obtaining a registration and obtaining a license. Notified medical devices are exempted from obtaining a registration; however they are not exempted from obtaining a license. Importers, manufacturers, distributors, whole sellers and retailers of presently unregulated Class A (low-risk) and Class B (medium-risk) medical devices sold in India will have to compulsorily obtain a license from appropriate licensing authority. A registration of medical device is done by the Central Drugs Standard Control Organisation (CDSCO) whereas a license is issued by state licensing authority or central licensing authority depending upon the class of medical device for which license is sought. In order to obtain a registration the medical device should be ISO 13485 compliant. Licenses are to be obtained for sale of notified medical devices. However, as per latest guidelines supply chain of registered (ISO 13485 compliant) medical devices will not need licenses.
Regulating medical devices under the Drugs and Cosmetics Act is being criticised by many stakeholders. However, in our view it is an effective step towards ensuring quality and safety medical devices being used in the industry. Further, the Government has provided appropriate time to all the stakeholders to adapt to new regulations. Compliance to ISO 13485 standards will ensure supply and production of good quality medical devices.