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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

The IVD reagents classification catalog, “6840 In Vitro Diagnostics Reagents Classification Sub-catalog” was first published in 2013. The 2013 classification catalog divides IVD reagents into 22 categories. On October 20, 2020, NMPA published an announcement about the modification of this catalog. 29 out of 48 tests belonging to the category “tumor biomarkers related reagents” have been down classified from Class III to Class II medical devices. Examples include carcinoembryonic antigen (CEA) tests, squamous cell carcinoma antigen (SCC) tests, human epididymal protein 4 (HE4) tests, etc.

2. Clinical Trial Exemption Catalog

According to Decree No. 650, clinical trial is not required if class II and III devices are on the clinical trial exempt List. The List includes both medical devices and in vitro diagnostic (IVD) products. NMPA has updated the List almost annually since it was first released in 2014, for a total of six revisions (five officially published and one draft version, as of December 2020), with more products added to the list with each revision. A total of 1,002 medical devices and 431 IVDs are exempt from clinical trials in China. However, different from general medical device products, for predicate comparison of IVD reagents, the applicant is required to perform methodology comparison studies for the predicate and the product to be marketed under non-clinical trial settings to prove their equivalency.

3. IVD Guidelines and Standards

With continuous effort, NMPA has established a relatively complete regulatory system for IVD products. More than eighty guidelines have been officially published and imposed to guide the registration of IVD reagents. Besides relevant guidelines, IVD products need to meet the requirements of applicable national/industrial standards. There are more than 200 standards established for IVD products in China.

CDx Regulatory Landscape in China

CDx in China

The CDx reagents has been regulated under IVD. Similar to the U.S., China considers the CDx IVD reagents as high-risk, denoting them as class III IVD products.

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?

Our Expertise

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.

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

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