Driving faster approvals and full-lifecycle compliance for global device brands.
Medical devices power global healthcare - from diagnostics and monitoring to advanced intervention technologies. The sector thrives on continuous innovation, aging populations, and digital health transformation. As regulation intensifies worldwide, market success depends on precise execution across global approvals, quality systems, and lifecycle compliance — making strategic regulatory readiness a competitive advantage.
Why Medical Devices Face Regulatory Delays - Even When the Innovation is Ready
From shifting classification rules to country-specific quality standards, the path to global approval for medical devices is complex, fragmented, and constantly evolving.
The same device may fall into different risk classes across regions - affecting submission requirements and timelines.
510(k), CE Marking, CDSCO, and NMPA dossiers all differ - requiring localized formats, evidence, and process navigation.
PMCF, vigilance, and complaint handling requirements vary by region - and are tightening globally.
UDI requirements, Arabic or Thai labelling, and import licenses are non-standardized and often overlooked.
Frequent changes in EU, China, ASEAN, and others demand real-time monitoring and agile response.
ISO 13485 may not meet local GMP or QMS expectations - especially in Brazil, India, and Saudi Arabia.
From classification to post-market compliance, Regnova helps device innovators navigate evolving regulatory landscapes and accelerate access to global markets.
Define submission routes across different regions like US, EU/UK, APAC and GCC etc. Customized market entry strategies for each country or region Risk classification and product gap analysis
Preparation of 510(k), CE Marking Technical Files, CSDCO Form MD-14, etc. Hands-on support for EUDAMED registration, UDI compliance, and labelling
Act as your Marketing Authorization Holder or help appoint qualified in-country partners. Supporting Market Authorization Holder (MAH) transfer and license maintenance
Set up AE tracking, PMCF plans, and complaint systems per MDR, FDA, and APAC norms.
Manage global labeling compliance with UDI, multilingual IFUs, and HA-specific formatting.
Prepare for ISO 13485, MDSAP, and local GMP audit readiness. Audit preparation and remediation support for Notified Bodies and FDA inspection
Liaise with NBs, manage deficiency responses, and support review acceleration.
Your execution-first partner, bridging regulatory precision with innovation acceleration
From fast-track launches to seamless regulatory transitions, see how RegNova powers brands toward global expansion success.
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Let’s accelerate your compliant innovation, market entry success, and global expansion together.
