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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.

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What is IVD in China?

IVD products including instrumentation platforms, corresponding software, and IVD regent are regulated in China in accordance with the relevant regulations for medical devices (Decree 680). The IVD reagent is also regulated under regulations for IVD products. Similar to as in the U.S., China considers the CDx IVD reagents as high-risk, denoting them as class III IVD products. Despite the potential market for CDx products, NMPA provides no specific guidance for CDx product registration.

Our Core Expertise

Gap analysis and regulatory strategy development

  • 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 info@chinameddevice.com