With the constant change of regulations, application strategy and risk assessment are very important for the applicant. It is essential to understand regulations and utilize previous experiences to increase success rate. Our regulatory affairs team has diversified professional background and provides accurate and in-depth interpretation of regulations, offering personalized and customized regulatory affairs services to our clients. In the past 20 years, the team has accumulated more than 5,000 product registration experience, covering all segments of medical devices. With a complete chain of regulatory affairs logic and modular services, we provide customized services to meet the needs of customers and give customers feasible advice from the perspective of professional registration regulations and practical experience.
Regulatory Consultation
If medical device manufacturers / agents / distributors have any pre-market system, registration, clinical, and post-market regulatory queries, we can provide professional regulatory consultation service. We will comprehensively consider the possible risks involved in all aspects of the queries raised, integrate the relevant resources of the company, help customers consider the overall situation, and avoid subsequent hidden problems.
1. System / Registration / Clinical Query Clarification
2. Strategy planning
3. Regulation and policy interpretation
4. Testing consultation
5. Registration documentation review
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
6. Preparation of annual risk assessment reports
7. Assist in handling random market inspections
8. Assist in handling medical insurance consumables system management and post-market regulatory support
9. Advertising approval
10. Assistance in processing UDI code registration
China NMPA Registration Services
Medical devices, which are / will be marketed and used in the People’s Republic of China, shall be registered / filed with the NMPA / local authorities. We can recommend the product registration path for companies, formulate the most reasonable marketing strategy, give warning to possible risk points in advance, and provide reasonable suggestions for risk avoidance to improve the efficiency and to increase success rate of product approval. We can provide you with the proper services regardless of the status of the product. Our services include but not limited to:
1. Product Classification Application / Attribute Application
2. Class I device filing / change filing
3. Class II / III device initial registration
4. Class II / III device renewal registration
5. Change filing of Class II / III device
6. Change registration of Class II / III device
7. Clinical trial application
8. Intent for Use (IFU) changes
9. Medical device certificate re-issuance / error correction / cancellation
10. Other green channel applications, such as innovation application, priority review, emergency use approval, etc
Global Medical Device Registration
We have offices around the world, and have maintained close contact with the local authorities. Through analyzing the specific cases of medical devices companies and manufacturers, we provide more direct and professional guidance, along with reasonable marketing strategies.
We offer professional medical device registration services globally and is currently committed to the registration approval certification of CE (MDR, IVDR, PPE, AIMDD), FDA (listed, 510K, PMA), Japan, South Korea and other countries.
