Medical Device Regulatory Approval and GMP Specialized Consulting
From manufactured and imported medical devices to IVD and overseas-certified products, Meditip supports the entire process of approval, quality, clinical trials, and post-market management with strategies optimized for each product's characteristics and regulatory stage.
Medical Device Regulatory Approval
From strategy development tailored to product type and approval stage to technical document review, safety and efficacy review, and clinical trial plan approval, we provide expert support across the entire medical device regulatory approval process.
Key Services
- Manufacturing Development and Regulatory Approval Consulting
- Safety and Efficacy Review
- Imported Product Regulatory Approval Consulting
- Exploratory and Confirmatory Clinical Trial Plan Approval
- Technical Document Review
- Medical Device License Renewal Support
Medical Device GMP
We support the entire process of GMP acquisition for all domestic and overseas medical device product lines, as well as the establishment of quality management systems such as ISO 13485 and GSP, and the maintenance of certifications.
Domestic GMP
Key Services
- Manufacturing Development GMP Consulting
- Medical Device GSP
- Imported Product GMP Consulting
- Annual Quality Management
Overseas Certification
Key Services
- ISO 13485:2016
- MDSAP
Post-market Management
Key Services
- Medical Device Post-market Management
- Manufacturing Site Quality System Audit
- Insurance Listing and Insurance Affairs Support
IVD (In Vitro Diagnostic Medical Devices)
We provide IVD-specialized consulting services covering manufacturing and import approval, technical document review, clinical performance testing, reevaluation, and manufacturing business licensing for in vitro diagnostic medical devices.
Key Services
- Manufacturing and Import Product Approval / Change Approval
- In Vitro Diagnostic Medical Device Reevaluation
- Technical Document Review
- Manufacturing / Import Business License
- Clinical Performance Test Plan Approval
- Manufacturing Development Consulting