Gunjan Verma - India

“Manufacturers will want to take note that BIS certification is required and enforced for many electronic devices, some of which may be components of certain medical devices. ”

Gunjan Verma
Managing Partner
Asia Actual India

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India Requires Mandatory Local BIS Certifications for Certain Medical Devices

Published on: February 22nd, 2023

Indian Customs will stop shipments at the border of some products which include electronic components without BIS (Bureau of Indian Standards) certification. This blog serves as an important reminder for manufacturers/importers that BIS certification is mandatory for some of the electronic components/accessories included in medical devices (medical electronic equipment), including batteries, monitors, power adaptors and more. These BIS standards have been in place for years for electronic goods and are extended to medical devices that have electronic devices as components, meaning acquiring BIS certification will be crucial for manufacturers/importers with affected products in order to achieve smooth entry into India. 

Important to note is that manufacturers of medical devices may require a separate BIS certification for certain products/accessories or peripheral equipment that are not classified as medical devices, used either as a standalone product or as a part of electronic medical equipment. 

For more information on this topic, Asia Actual released a blog covering BIS standards in March 2022 which can be read here. If you have additional questions on the subject, please feel free to get in touch with us here. 

List of Products Affected by India BIS Certification Enforcement

The products affected are uniformly electronics, including standalone products as well as electronic components (which are included in many medical devices). Below are some of the possible items that may be incorporated in imported medical equipment/devices that would necessitate a medical device become BIS certified: 

Sr. 6 – Laptops/Notebooks/Tablets 

Sr. 26 – Power Adaptors for audio, video & similar electronic apparatuses  

Sr. 27 – Power Adaptors for IT Equipment 

Sr. 40 – Visual Display Units & Video Monitors (Screen size up to 32 inch) 

Sr. 49 – Storage battery 

These devices must be tested in BIS accredited laboratories, the list of which can be found here. Without BIS approved testing, medical devices that include these electronic components will have trouble achieving market access in India. (NOTE: Non-rechargeable batteries are not included in the above devices and are not affected by the requirements.) 

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. 

Grow With Us

Please contact us if you have questions regarding BIS standards and/or are interested in registering your product in India. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.  

Asia Actual is a regulatory consulting company focused on helping manufacturers grow sales in challenging Asia markets through independent license holding, direct fulfillment, and a variety of sales channel support services.    

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