Pharma CTD Dossier and Medical Device Regulations in India

1. +91 7672005050, +91-11-28081765 contact@cliniexperts.com Pharma CTD Dossier and Medical Device Pharma CTD Dossier and Medical Device Regulations in India Regulations in India Summary: Before some years there were not many rules for introducing a new medical device in the market but with the developing scope of technology, the market became flooded with many new devices Therefore, to ensure the safety, many rules and regulations has been set by concerned authorities. This article will give you a brief knowledge on medical device regulations in India. Since a long time, the medical device industry has been demanding to separate themselves from the pharma industry so that the strict laws that controls the drug industry must not apply on the medical device industry. The government of India finally framed some specific rules for medical device regulation India and that came into effect on January 1, 2018. Let's have a look on some of the common points for medical device regulation. The medical devices that are intended for internal and external use for the diagnosis, treatment or prevention of disease in human beings fall under Drugs and Cosmetics Act, 1940 and regulated by CDSCO. Some specific substances that will affect the structure or function of human body are notified by government from time to time. Presently, those substances are mechanical contraceptives and disinfectants. Then there are certain other substances like surgical dressings, surgical bandages, surgical sutures, ligatures, substances utilized for vitro diagnosis and substances for being used as diagnosis, mitigation or prevention of diseases in human beings and animals are controlled by the concerned authority of government of India. Different classes of medical devices and their respective assessment authority. At present there are four categories or class of medical device based on their risk type ● Class A belongs to low risk device and its assessment authority is State Licensing Authority. ● Class B belongs to low moderate risk device is also assessed by State Licensing Authority. ● Class C are moderate high-risk devices and its assessment authority is Central Licensing Authority.

2. +91 7672005050, +91-11-28081765 contact@cliniexperts.com ● Class D devices are high risk devices and it’s review falls under Central Licensing Authority. Do you know what is Pharma CTD dossier? It is a vital part of any pharmaceutical product registration process, which is needed to be submitted in the CDSCO Department under the Ministry of Health and Family Welfare. The CTD dossier is a widely accepted format of dossier and is submitted along with other required documents for registration or license of any new pharmaceutical product. Medical Device Registration Now when you have an idea on Medical Devices, you must know when a new medical device is introduced, imported or exported then also the concerned person have to do registration from the respective authority of the Indian Government. The regulatory bodies who are responsible for medical device registration India are ● The Central Drug Standards Control Organization ● The Drug Controller General of India ● Central Licensing Authority and State Licensing Authority. Thus, for a new medical device it is required to be registered with the concerned authority under the Government of India before introducing in the market. Author: The author is a medical expert with years of experience in the concerned field. He has worked on the top managerial levels in multiple companies and loves to help people related with health and pharma related matters.