Snehita Shukla
Learning / / Page 5
Learning / / Page 5
In India, the Central Drugs Standard Control Organization regulates all drugs, medical devices, etc. It monitors the standard and quality of medical devices, drugs, and cosmetics in India. CDSCO is the National Drug Regulatory Authority responsible for establishing regulations and standards for medical devices, drugs, and IVDs. CDSCO Certificate in Public Health Domain plays a […]
Due to the large population, high demand and quick expansion of the medical device business, Indian medical device manufacturers are in favour of the establishment of medical device manufacturing units. The medical device rules 2017[1] were introduced in order to meet the global standards of the medical device industry. There is a classification of medical […]
Central Drug Standard Control Organization or CDSCO is responsible for regulating and conducting clinical Investigations on Drugs in India. Chapter VII of the Medical device rules describes the clinical investigation of medical devices and clinical performance tests of new in vitro Diagnostic medical devices. The manufacturer or importer is required Application for Clinical Investigation of […]
CDSCO is the National Regulatory Authority of India, which operates under the Ministry of Health and Family Welfare, under the Directorate General of Health Services, Government of India, and is responsible for regulating Medical devices, IVDs and Drugs in India. It is the Central Drug Authority of India, and is regulated by Drugs and Cosmetics […]
Central Drug Standard Control Organization, or CDSCO, is the National Regulatory Authority of India and is responsible for the regulation of Medical Devices, IVDs and Drugs in India. It works under the Ministry of Health and Family Welfare, which is regulated by the Directorate General of Health Services under the Indian Government. CDSCO is also […]
The Central Drug Standard Control Organization[1] regulates the Indian medical device Industry under the provisions of the Drugs and Cosmetics Act and Rules. Every country, like India, has its own regulatory body to look after every aspect of medical devices and drugs related services. The CDSCO looks after the regulation and sales of notified medical […]
The Central Drug Standard Control Organization (CDSCO)[1], which serves as India’s National Regulatory Authority (NRA), oversees all the medical devices sold in the country. The Drug Controller General of India (DCGI) is in charge of CDSCO. The Directorate General of Health Services, under the Ministry of Health and Family Welfare, is in charge of CDSCO. […]
The Central Drug Standard Control Organization (CDSCO) is the national regulatory body of India. The Ministry of Health & Family Welfare, Government of India, oversees it through the Directorate General of Health Services. It is governed and regulated by the Drugs and Cosmetics Act and is responsible for the approval of drugs, setting their standards, […]
The Central Drug Standard Control Organization (CDSCO) is the National Regulatory Authority (NRA)[1] of India. It works under the Directorate General of Health Services, under the Ministry of Health and Family Welfare, Government of India. It is regulated by the Drugs and Cosmetics Act and is responsible for the approval of drugs, laying down their […]
According to the Medical Device Rules (MDR) 2017[1], a small quantity of Class A, B, C, and D medical devices can be manufactured to perform clinical investigation, test, examination, demonstration or training. For this reason, an application form is made in the form MD-12 and is required to be submitted to the Central Licensing Authority, […]
According to section 40 of the Medical Device Rules 2017[1], any kind of medical device or in-vitro diagnostic medical device may be imported in order to run any kind of clinical investigation, test, training, etc. Any person who is willing to import medical device is required to apply for a test license for the same. […]
The Medical Devices and Rules, 2017 maintains the guidelines to provide a framework of the rules and regulations of Drugs, Medical Devices, Medical related products, IVDs etc. To manufacture the medical devices, the manufacturer also needs to acquire a manufacturing license from the licensing authorities. The same is the case with acquiring a loan license […]
The Central Drug Standard Control Organization (CDSCO) is the National Regulatory Authority or NRA of India, which works under the Directorate General of Health Services, under the Ministry of Health and Family Welfare under the government of India. The DCGI is the head of CDSCO, responsible for issuing medical device rules and additional regulations. To […]
Medical devices and IVDs are regulated & controlled by the Drug Controller General of India, also known as DCGI, which operates under the Central Drugs Standard Control Organization (CDSCO)[1]. CDSCO is a part of the Ministry of Health and Family Welfare. The rules and Regulations of Medical devices are based on Medical Device Rules, 2017. […]
