Zephyrnet Logo

Tag: regdesk medical device

MDCG Manual on Borderline Products: Key Principles in Detail

The article highlights the key points to be considered when determining the regulatory nature of products considered general medical devices.  Table...

Top News

MDCG Guidance on CABs and NBs: Decision on Designation

The new article describes the way the designating authority will take its decision on the designation of an applicant entity.  Table...

MDCG Guidance on CABs and NBs: Post On-Site Assessment Activities

The new article describes the actions to be taken by the parties involved upon completion of an on-site assessment.  Table of...

MDCG Guidance on CABs and NBs: On-site Assessment Activities

The new article provides additional details regarding the on-site inspection activities to be undertaken as a part of the designation process.  ...

MDCG Guidance on CABs and NBs: Application Review and Transmission

The article describes in detail the regulatory procedures to be performed for an application for designation as a conformity assessment body under the new...

MDCG Guidance on Conformity Assessment Bodies and Notified Bodies: Application Pre-assessment

The article provides an overview of the European regulatory requirements in the sphere of conformity assessment bodies and notified bodies set forth by the...

MDCG Guidance on Alternative Solutions for IVDs: Overview

The article provides an overview of the clarifications provided concerning solutions available during the temporary unavailability of the global European database.  ...

DRAP Guidance on Clinical Trials Applications: Documents

The new article describes in detail the aspects related to the documents the authority expects the applicant to submit concerning the clinical trials.  ...

NHRA Guidance on Medical Device Importation Approval: General Rules and Specific Aspects

The new article describes in detail the general rules related to the importation permits, as well as certain specific aspects, such as violations, product...

DRAP Guidance on Clinical Trials: Registries and Investigator’s Brochure

The new article describes specific aspects related to the registries containing information about clinical trials, and also to the Investigator’s Brochure – a particular...

Kenyan Guidance on PMS: Three Steps Approach, Documentation, and Reporting

The new article explains the three steps testing approaches and highlights the key points associated thereto. The document also addresses the aspects related to...

DRAP Guidance on Clinical Trials Applications: CGP Compliance Audits and Reports

The new article describes in detail the regulatory matters related to audits or inspections for GCP compliance, as well as the reports and final...

Kenyan Guidance on PMS: Procedure and Testing

The new article provides additional clarifications regarding certain specific aspects related to post-market surveillance, including the activities to be undertaken by the parties involved...

Latest Intelligence

spot_img
spot_img