Regulatory Affairs Associate

Regulatory Affairs Associate Interview Questions and Answers

Updated 3 May 2024

Q1. Procedures for variation

Ans.

Procedures for variation involve submitting a variation application to regulatory authorities for approval.

  • Variation application should include detailed information on the proposed changes

  • Regulatory authorities may require supporting data or documentation to support the variation

  • Variation procedures may vary depending on the specific regulations and guidelines of the country or region

  • Changes to labeling, manufacturing processes, or formulation may require variation applicatio...read more

Q2. Mdd and MDR transition difference

Ans.

The main difference between MDD and MDR transition is the increased requirements for medical device manufacturers under MDR.

  • MDD (Medical Device Directive) is the previous regulatory framework for medical devices in the EU, while MDR (Medical Device Regulation) is the updated and more stringent regulation.

  • MDR introduces new classification rules, stricter post-market surveillance requirements, and enhanced transparency through the EUDAMED database.

  • Manufacturers need to comply w...read more

Q3. Types of variation

Ans.

Variations in regulatory submissions include major, minor, and administrative changes.

  • Major variations involve significant changes to the product, such as formulation or indication.

  • Minor variations are less significant changes, like packaging updates.

  • Administrative variations are minor administrative changes, like contact details.

  • Examples: Major - adding a new indication, Minor - updating packaging design, Administrative - changing contact information

Q4. Mdr regulation 2017/245

Ans.

MDR regulation 2017/245 is a regulation that governs medical devices in the European Union.

  • MDR regulation 2017/245 replaces the previous Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD).

  • It introduces new requirements for medical device manufacturers, importers, and distributors.

  • The regulation aims to improve patient safety and ensure the quality and performance of medical devices.

  • MDR regulation 2017/245 also includes stricter rules for cl...read more

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