regulatory insights
Global Regulatory Updates for Life Sciences Companies
RJR monitors life sciences regulatory updates across global markets to help companies understand what is changing, where it applies, and what may require action. Explore developments affecting product development, submissions, market entry, quality, and ongoing compliance.
LATEST UPDATES
Recent Life Sciences Regulatory Updates
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Saudi FDA Issues Guidance on Medical Device Bundling
Saudi FDA medical device bundling MDS-G28 explains when device groupings may share one MDMA application and when separate submissions are needed.
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Malaysia and Thailand Implement Medical Device Regulatory Reliance Programme
Malaysia–Thailand medical device reliance supports Class B, C, and D registrations through streamlined pathways between MDA and Thai FDA.
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Chile Expands Sanitary Control for Medical Devices and IVDs
Chile medical device registration expands to 39 higher-risk devices and IVDs under Decree No. 25, with phased compliance through the ISP.
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FDA Signals 510(k) Relief for Additional Unclassified Devices
FDA 510(k) exemption guidance adds five unclassified device codes to enforcement discretion while formal exemptions remain pending.
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UK MHRA Publishes Draft Pre-Market Requirements for Medical Devices and IVDs
UK MHRA pre-market requirements propose changes to international reliance, UDI, implant cards, IVD classification, documentation, and device claims.
AREAS OF FOCUS
Regulatory Topics Across the Product Lifecycle
RJR’s insights address developments that may affect product strategy, submissions, market entry, quality systems, and ongoing compliance across global markets.
Product Development & Regulatory Strategy
Early regulatory intelligence, pathway planning, classification, and market sequencing for products in development.
Submissions & Market Entry
Requirements affecting dossiers, registrations, health-authority interactions, local representation, and launch readiness.
Quality Systems & Compliance
Changes involving quality-management systems, manufacturing controls, audits, labeling, and ongoing compliance.
Post-Market & Lifecycle Management
Updates affecting surveillance, vigilance, product changes, renewals, corrective actions, and continued market access.
NEXT STEPS
Need Help Interpreting a Regulatory Change?
Share the market, product category, and regulatory development affecting your program. RJR can help assess its potential impact and identify the appropriate next steps.