Role of the Regulatory Affairs Department in Medicinal Gas Industry
The Regulatory Affairs (RA) Department ensures that all medicinal gases—regardless of their classification as medicinal products or medical devices—comply with applicable regulatory requirements throughout their lifecycle. This includes oversight of product development, manufacturing, distribution, and post-market activities.
Key Responsibilities:
- Regulatory Compliance: Ensuring that all products meet the legal and regulatory requirements set by national and international health authorities, including compliance with Good Manufacturing Practice (GMP) for medicinal products and conformity with medical device regulations.
- Regulatory Strategy and Development Support: Providing regulatory input during product development, including classification decisions, clinical and non-clinical requirements, and interactions with regulatory authorities.
- Product Registration and Lifecycle Management: Preparing, submitting, and maintaining regulatory documentation for marketing authorizations, CE marking, renewals, and variations. This includes managing technical files and declarations of conformity.
- Labeling and Documentation: Ensuring that product labeling, instructions for use, and safety information are accurate, up to date, and compliant with applicable regulations.
- Liaison with Regulatory Authorities: Acting as the primary contact point for communications with national and international regulatory bodies, including during inspections and audits.
- Post-Market Surveillance: Monitoring the safety and performance of products after market release. This includes adverse event reporting, field safety corrective actions, and periodic safety updates.
- Internal and External Audits: Participating in or conducting internal audits to assess compliance with regulatory requirements and company procedures. Supporting external audits by regulatory authorities or notified bodies, and ensuring timely implementation of corrective and preventive actions (CAPAs) where needed.
This comprehensive role ensures that medicinal gases are developed, manufactured, and distributed in accordance with all applicable legal and safety standards, supporting both regulatory compliance and patient safety.
