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The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics, pharmaceuticals and medical devices. It serves a similar function to the Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union .
Analysis of Cosmetics received as survey samples from CDSCO (central drug standard control organisation) With the notification of Medical Device Rules 2017 by the Government of India, DCGI will also act as Central Licensing Authority (CLA) for the medical devices which fall under the purview of these rules.
Many developed countries set up their pharmacovigilance programs following the Thalidomide scandal in the 1960s. [2] India set up its program in the 1980s. [2] This general concept of drug safety monitoring went through different forms, but the Central Drugs Standard Control Organisation established the present Pharmacovigilance Program of India in 2010. [2]
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
The CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
To establish a reference range, the Clinical and Laboratory Standards Institute (CLSI) recommends testing at least 120 patient samples. In contrast, for the verification of a reference range, it is recommended to use a total of 40 samples, 20 from healthy men and 20 from healthy women, and the results should be compared to the published reference range.
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.