We have a dedicated IVD team to provide end-to-end services for IVD products. The team possesses extensive experience in research, clinical work, and regulatory affairs, ensuring a seamless process from development to market entry for IVD products.
Product Design and Development
Our IVD team has rich experience in serving the innovative development of IVD products. We can provide customers with regulatory and systematic services during the product design and development stages.
1. Establishment of the R&D quality system
2. Product registration strategy (Product development consultation report)
3. Input and output support during the R&D stage
4. Product verification and design validation
5. Technical documentation guidance
6. Design translation guidance
7. Analysis Performance studies
8. Reference range studies
9. Exploratory clinical studies
Regulatory Consultation Service
At present, relevant policies and regulations on medical devices change frequently globally and requirements are becoming increasingly stringent, leading the increasing compliance cost. We provide full lifecycle regulatory services on IVD products for the client and promote product compliance.
1. China and global regulatory consultation
2. China and global regulatory training and interpretation
3. Strategy design and assessment
4. Regulatory update
Product Classification Service
Each country implements classified and graded management for products with different risks. The regulation and control over the full life cycle of the products, including R&D, manufacturing, operation, registration and clinical use, are different for products in different categories. To avoid over or insufficient management caused by ambiguous product classification, and to provide references for reasonable and efficient resource allocation for the enterprise and regulatory authorities, we provide the following product classification service for enterprises.
1. Classification documents preparation guidance
2. Track the application process
Agent Related Services
We can serve as customer’s legal representative to handle product registration / filing, post-marketing regulatory activities, and communication with relevant authorities. We have a history of over a decade in providing agent services and has developed a comprehensive and mature process with extensive experience in this field. We offer the following services:
1. Assist in communication with the corresponding regulatory authorities
2. Convey regulations and standards to manufacturing company
3. Collect post-marketing AEs and report them to authorities / manufacturers
4. Assist in handling recalls and report to authorities
5. Assist manufacturers in handling other post-market regulatory tasks
China and Global Registration Services
Reflected in policies and regulations, different countries have different risk classifications and review requirements for IVDs. The reform of the review and approval system for IVDs is deepening constantly in China. With the industry development, global promotion of products speeds up, and the need of global distribution of products increases continuously. As a global CRO, Tigermed-Jyton can provide regulatory support for China NMPA and global registration for the IVD products.
Services related to product registration, covering various risk levels, including initial registration, changes, and certificate extensions:
1. Preparation of product technical requirements
2. Product registration testing / third-party testing
3. Preparation of product registration dossiers and pre-evaluation / third-party pre-evaluation
4. Evaluation process tracking, coordination and communication
5. Preparation and feedback of supplementary information
Clinical Trial Services
We are experienced in providing clinical trial services for IVDs. In accordance with current regulations, GCP and corresponding guidelines, we can provide clinical trial related services for:
1. Registrational clinical trial
2. Real-world study
3. Analysis performance studies
4. Reference range studies
5. Exploratory clinical studies
6. Product R&D stage and post-market clinical studies
7. Registrational clinical evaluation
Related services cover:
1. Product clinical study design
2. Third-party audits
3. Clinical trial project management and tracking
4. Data management and EDC software system
5. Clinical trial statistics support
6. Clinical trial report writing
Product Manufacturing and Quality System
We provide the following product production and quality system related services:
1. MAH policy consultation
2. ISO 13485 and ISO 9001 certification guidance
3. Full lifecycle quality system service
4. GMP workshop design counseling and on-site review
5. Product production and quality control under the GMP environment
6. Third-party audit of quality systems
7. Computer information management system
8. Risk management guidance: Registration application and post-marketing follow up study
