DeviceDee Regulatory Affairs Department provides customized regulatory services for medical devices, based on domestic (CFDA) and international ( including CE、510k、CMDCAS、TGA、Thailand、Malaysia、 South Korea、IMMETRO etc.) regulatory. Our regulatory experts have years of experience with related authorities and are very familiar with regulatory requirements, they can provide you with feasible strategies and facilitate your communication with various regulatory agencies, both on technical and regulatory issues.We provide our clients with valuable advice and guidance, aiming to help reduce costs, save time, and improve the chances of successful registration of promising medical devices.

Our clinical trial operating team is comprised of domestic and overseas clinical experts, biostatistical scientists, and clinical research associates. By managing projects professionally and maintaining a good relationship with investigators, we always accomplish our projects as scheduled, hence help accelerate product launching and obtain high quality data.

GMP consulting is an important service we provide. Our services is to setup, improve and audit the GMP for medical device manufacturers. The aim is to help them achieve the standard which fulfills the authorities’ requirements. We provide our GMP consulting services based on different standard according to client’s requirements, such as CFDA GMP, ISO13485:2016, 21CFR820 or MDSAP.

INTERNATIONAL COOPERATION OPPORTUNITIES