China, a market that you cannot 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 product in China is complex. Although NMPA (CFDA) becomes more harmonized with international standards, the China market approval is still of great challenges for foreign IVD/CDx manufacturers.
IVD Regulatory Landscape in China
1. IVD Classification Catalog
2. Clinical Trial Exemption Catalog
3. IVD Guidelines and Standards
CDx Regulatory Landscape in China
CDx in China
China NMPA has been lagging behind its counterparts in the US and FDA in issuing guidance regulating CDx area. There is no guidance specifically for CDx until NMPA published the “Revisions for instructions for use and technical review of tumor companion diagnostics based on similar therapeutic drugs (Draft)” on July 7, 2020 for public comments. About one month later, NMPA published another guideline for CDx clinical trial, “Clinical Trials Guidelines for Companion Diagnostic Reagents for Approved Anti-tumor Drugs (draft)”. In addition, NMPA announced its preparation of “Technical Review Guideline of Clinical Trial for Co-development of CDx Reagents and Anti-tumor Drugs” on June 3rd, 2020.
The increased frequency of the CDx guidance suggests that NMPA CMDE is starting to pay more attention and intends to regulate more in the CDx domain. CDx is picking up the pace in China now.
How Can We Help?
Some of our core expertise are:
- Product verification and validation
- 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 email@example.com.
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory, clinical affairs and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their needs to set up local entity in China. Our NMPA (CFDA) regulatory and clinical affairs services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), full service clinical trials, QA, GMP and post-market compliance. Our commercialization services include market assessment research, reimbursement, partnership strategies, and distribution qualification.