Snehita Shukla

As per the Ministry of Health & Family Welfare, there has been a recent amendment in the Medical Device Rules, 2017[1]. The Official Gazette G.S.R. 102 (E) was made public on 11th February 2020. It notified that the medical devices must be registered with the Central Licensing Authorities via an online portal, which CDSCO regulates. […]

The Central Drugs Standard Control Organization or CDSCO, is the Indian medical device industry regulatory body. Each country has a specific regulatory body under the ministry of health to handle all facets of drugs and both notified and non-notified medical devices. The Central Drugs Standard Control Organisation lists 26 medical devices for Classification of Medical […]

BIS Compulsory Registration Scheme (CRS) The Bureau of Indian Standards, also known as BIS, is the National Standard Body of India. The Compulsory Registration Scheme is governed by the Bureau of Indian Standards (Conformity Assessment) Regulation, 2018 by the BIS Act 2016[1]. (Scheme II of Schedule II). The Scheme’s main objective is to aid the […]

The BIS Certification for Wireless Microphones is approved under Indian Standard IS 616:2017 for the safety requirements for audio, video, and similar electronic apparatuses. Before they are produced, sold, or imported into the Indian market, all models and brands of wireless microphones must obtain a BIS Certification under the BIS standards. Only manufacturers are given […]

The Ministry of Health & Family Welfare[1] under The Government of India was notified on 20th September 2022, notifying the draft of amendments related to Medical Device Rules. The draft informs about the provisions related to registration of Class A Non-Sterile and Non-Measuring Medical Devices under the Medical Device Rules. As per the notification, a […]

Passport Reader is a part of the mandatory BIS Compulsory Registration Scheme as per Indian standard – IS 13252 (Part-1). It cannot be imported, exported or sold in the Indian market without obtaining BIS Certification for Passport Reader. The Compulsory Registration scheme falls under the Scheme II of BIS (Conformity Assessment) Regulations, 2018. In this […]

The BIS Certification for Smart Speakers is certified under Indian Standard IS 616:2017 under Audio, video and similar electronic apparatus-safety requirements. According to the BIS standards, all models and brands of Smart speakers (with and without display) must get a BIS Certification for Smart Speakers before they are manufactured, sold or imported to the Indian […]

The BIS Certification for Webcams complies with Indian Standard IS 616:2017, which addresses the safety requirements for video, audio, and similar electronic apparatus. Before being produced, sold, or imported into the Indian market, all models and brands of webcams (finished products) must obtain a BIS certification for Webcam. The BIS registration is only given to […]

Cosmetics can be described as any article intended to be rubbed, poured, sprinkled, sprayed, introduced into, or applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance. This definition also includes any article intended for use as a cosmetic component. The Drugs and Cosmetics Act 1940[1] and […]

BIS Registration is required for Rice cookers, categorised under IS 302 (Part 2). It falls under the List of Electronics and IT Goods under the ‘Compulsory Registration Scheme’ for Self Declaration of Conformity-Notified by the Ministry of Electronics and Information Technology[1]. Before the shipment of rice cookers to the Indian consumer market, the Compulsory Registration […]

Central Drugs Standard Control Organization (CDCSO) is the highest Indian regulatory body that monitors the production of authorised medical devices. CDSCO is in charge of issuing licences and approving the manufacturing of medical devices. This problem of regulatory body Medical Device Manufacturing License by the Medical Device Rules of 2017[1]. While manufacturing medical devices, a […]

The Legal Entity Identifier (LEI), a 20-character alpha-numeric code created by the International Organization for Standardization, is based on the ISO 17442 standard (ISO). The benefits of LEI Number is that it connects to crucial reference data, making it possible to clearly and specifically identify the legal entities taking part in financial transactions. Each LEI […]

The cosmetics market in India is expanding exponentially and is almost twice as big as those in the US and Europe. The Ministry of Health & Family Welfare in India has ordered that all goods brought into the country must have a mandatory registration certificate due to the industry’s expansion. Therefore, there must be a […]

A predicate device is a device that most closely resembles the medical device in terms of indications of use and technological characteristics. A predicate medical device has been registered/approved in India. It has the same indications/intentional use, material of construction, and design characteristics as the device being proposed for registration in India. New medical devices […]