China, a market that you can not ignore for IVD manufacturers in the past several years still holds great growth potential due to its high demand of cancer diagnostics tests, companion diagnostics (CDx), and sequencing-based cancer assays.
IVD & CDx Expertise
With continually evolving regulations, the regulatory landscape pertaining to IVD, especially CDx products in China is complex. Although NMPA becomes more harmonized with international standards, China’s market approval is still of great challenges for foreign IVD/CDx manufacturers.
China Med Device (CMD) assists IVD and CDx manufacturers to comply with China regulations throughout the whole product life cycle. From preparing regulatory strategies to providing registration/renewal/modification submission and post-marketing surveillance (PMS) services, we deliver unparalleled expertise. With proactive interactions with regulatory offices as well as the clients, CMD will enable your success on China entry.
What is IVD in China?
Our Core Expertise
- Classification identification
- Clinical protocol design and execution of clinical trials
- Predicate device identification, CER preparation
- Registration/renewal/modification dossier preparation and consultation services.
- PTR writing and testing related services (type testing, biocompatibility, stability etc.)
- GMP/QMS, Certification & Compliance
- Post Market Surveillance
To unlock the IVD/CDx China market, please contact firstname.lastname@example.org