The article provides an overview of the European regulatory requirements in the sphere of conformity assessment bodies and notified bodies set forth by the existing regulatory framework. In particular, the article addresses the matters related to the pre-assessment...
The article provides an overview of the clarifications provided concerning solutions available during the temporary unavailability of the global European database. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body...
The new article describes in detail the aspects related to the documents the authority expects the applicant to submit concerning the clinical trials. Table of Contents The Drug Regulatory Authority of Pakistan (DRAP), a...
The new article describes in detail the general rules related to the importation permits, as well as certain specific aspects, such as violations, product classification, sampling, and fees. The document constitutes a draft guidance the authority has published in...
The new article describes specific aspects related to the registries containing information about clinical trials, and also to the Investigator’s Brochure – a particular document that outlines the key points regarding the clinical study. ...