Snehita Shukla

About Snehita Shukla

Snehita has her qualifications in B.Com LLB and LLM, and holds a specialization in Corporate & Financial Laws and Policy. She is hardworking, dedicated and sincere. She has a great command in english and has great problem solving, critical thinking and writing skills which makes her stand out of the crowd. She has a keen interest in legal research work and content writing, she also has a hold in legal research methodology. She loves to take challenges and to explore new topics to research on. She aims to improve her knowledge and skills through her experience.

What is FORM MD-3 and FORM MD-5?

Strict procedures must be followed in accordance with the rules and guidelines established by the Central Drug Standard Control Organization (CDSCO) when manufacturing medical devices. Additionally, candidates must go through a process by submitting an application for a licence to sell or distribute medical devices if they want to manufacture Class A or Class B medical […]

An Overview of BIS ISI for Automotive Tubes & Tyres

All models & brands of automotive vehicles-Pneumatic tyres for two & three-wheeled motor vehicles are required to obtain ISI Certification, before their launch or import into the Indian market. BIS ISI for Automotive Tubes & Tyres will only be provided to product manufacturers (whether Indian or foreign) and not to traders, dealers, or distributors. Bureau […]

How to Get BIS ISI for Oil Pressure Stove?

All Oil-Pressure Stoves with Offset Burners have been added to the Mandatory ISI Certification Scheme under IS Standard-IS 10109. This item cannot be exported or imported or sold on the Indian consumer market unless it bears the ISI Mark. Bureau of Indian Standards grants BIS Certification / ISI Mark (BIS). ISI certification is renowned for […]

Different Classes of Medical Device & their Risk Levels – An Overview

The Central Drugs Standard Control Organization (CDSCO) is India’s national body for regulating medical devices and drugs. It performs duties comparable to those of the European Medicines Agency, Food and Drug Administration of the U. S., and the treatments and health services products Regulatory Agency of the United Kingdom. According to the Indian regulatory body, […]

Difference Between Notified and Non-Notified Medical Device

Medical equipment has traditionally been largely unregulated in India. That has transformed recently. Medical Devices Rules 2017 have become effective as of January 1st, 2018, according to Ministry of Health and Family Welfare Notification No. G.S.R, 78(E) dated January 31, 2017. There has been different regulations for notified and non-notified medical devices. In this write-up, […]

What is FORM-42 and FORM-43?

The term “cosmetic” is defined in section 3(aaa) of the Drugs and Cosmetics Act of 1940[1]. It states that “cosmetic” includes any item intended to be used as a cosmetic ingredient as well as any object meant to be rubbed, poured, sprinkled, sprayed, applied to the human body or any part for cleansing, beautifying, promoting […]

What are the Documents Required for ISI Certification?

Indian industrial products have carried the ISI mark since 1955 as a sign of their adherence to national standards. Products bearing this mark are guaranteed to be in compliance with an Indian Standard (IS) created by India’s Bureau of Indian Standards (BIS). Throughout the Indian subcontinent, people know and trust the ISI mark as the […]

An Overview of ISI Certification Procedure

In India, the Bureau of Indian Standards (BIS), is the national body for standardisation. BIS oversees standardisation activities as well as quality marking, quality assurance, and product certification, and other matters pertaining to these activities. Indian Standards Institute, also known as ISI, is a body entrusted with establishing the standards necessary for orderly business growth and […]

An Overview of CDSCO Registration Certificate for CT Scan Machine

The CDSCO is the National Regulatory Authority (NRA) of India, which works under the Directorate General of Health Services (DGHS)[1], Ministry of Health & Family Welfare, Government of India. CDSCO, a body that works under the Drugs and Cosmetics Act, is accountable for the approving of drugs and laying down the standard for drugs, to […]