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Global Product Registration
Global Product Registration for Medical Devices
Expand Your Market with Expert Regulatory Support
At Isha’s GMP Consultancy, we help medical device companies navigate the complex global regulatory landscape and gain market access efficiently. With experienced partners in multiple countries, we provide comprehensive regulatory support for medical device registration in the US, Europe, India, and other global markets.
Our Comprehensive Services for Global Product Registration
Regulatory Compliance & Conformity Assessment
- Assessment of Local Regulatory Bodies & Registration Requirements
- Device-Specific Conformity Assessment
- Technical File Review for Regulatory Compliance
- Clinical Survey Compilation & Review
Application & Approval Support
- Preparation & Submission of Registration Applications
- Handling of Queries from Regulatory Authorities
- Post-Market Surveillance & Compliance Management
- Authorized Representative Services for Specific Countries
Our Expertise Covers Major Regulatory Bodies
- USFDA (United States)
- European CE Marking
- CDSCO (India)
- ANVISA (Brazil)
- TGA (Australia)
- Health Canada
- MDR & IVDR Compliance for EU Market
- Other Global Market-Specific Registrations
Why Choose Isha’s GMP Consultancy?
- Expert Guidance for Global Market Entry
- End-to-End Registration Support
- Strong Network of Regulatory Partners
- Compliance with the Latest Regulatory Changes
Contact us today to ensure seamless global market entry for your medical devices!
Medical Device
- Regulatory Consulting for Medical Devices
- Quality Management Consulting
- Medical Device Turnkey Plant Setup
- Market Entry & Market Research Analysis
- Business Transformation & Growth Advisory
- Export Promotion
- Medical Devices Training Courses
- ISO 13485:2016 Certification
- Medical Device Registration
- Indian Authorized Agent for Medical Devices