India Requires Mandatory Local BIS Certifications for Certain Medical Devices

Indian Compulsory Registration Scheme: How it Affects Manufacturers/Importers

In 2012, the Compulsory Registration Scheme (CRS) was introduced by the Department of Electronics and Information Technology (DeitY) jointly with the Bureau of Indian Standards (BIS). On October 3rd, 2012, the department (whose name was later updated to the Ministry of Electronics and Information Technology or “MeitY”) released the notification “Electronics and Information Technology Goods (Requirement for Compulsory Registration) Order, 2012.” This notification served to categorize 15 different types of electronics. Later, more product categories were added, leading to there being 49 products at present affected by the notification.  

In accordance with this notification, no person shall manufacture or store for sale, import, sell or distribute goods which do not conform to the Indian standard specified in the order. It is required for manufacturers/importers of these products to apply for registration from the BIS and have them tested by a BIS recognized lab. Afterwards, the BIS registers the manufacturers as a part of its system and said manufacturers are allowed to declare that their articles conform to Indian standards. 

Registered manufacturers are required to display the standard mark as notified by the Bureau on the packaging of their product in a readily visible manner (registration number and words must be at least Arial font size 6). Showcasing the Bureau standard mark on product packaging is the way to demonstrate BIS certification.  

Under this system, it is mandatory to get the products that fall under the Compulsory Registration Scheme (CRS) registered with the BIS. You can find a list of products that fall under the CRS requirements here. 

It is important to note that the products that fall under CRS are not medical devices. However, if your medical device/equipment contain these products as components, then BIS registration is required for that particular item (which may be a component/part/accessory of the medical device). Please note that there may be issues with importing at Customs if the BIS registration is not complete for any of the 49 devices included under CRS. 

Be sure to check the medical electronic equipment that you plan to import and duly identify if your medical device products incorporate any of the 49 products listed in CRS as these will require prior mandatory BIS registration.