Due to the rising prevalence of chronic conditions such as cancer and diabetes in China and the increased focus on early diagnosis and reduced treatment costs, the in vitro diagnostics (IVD) market in China is growing rapidly. The National Medical Products Administration (NMPA) of China classifies IVD reagents as medical devices. The regulatory framework for IVDs has been established in the Provisions for In-Vitro Diagnostics Reagent Registration and Filing, which describes how IVDs will be classified, reviewed, approved, and monitored throughout their lifecycle. This guidance outlines the main requirements of the regulations and some practical issues that device manufacturers must take into account when attempting to register their IVD products in China.

Determine Whether Your Product Is Considered An IVD Reagent

According to the NMPA, IVD reagents are products used in vitro to test human specimens (blood, urine, or tissues) to assist with disease diagnosis, screening, monitoring, prognosis, or health evaluation.

IVD reagents include reagents, kits, calibrators, and control materials. Products used for blood screening or radionuclide-labeled reagents are not considered IVD reagents. Products not intended for medical diagnosis or health evaluation may fall outside this scope and should be assessed on a case-by-case basis.

Identify the Correct Risk Classification For Your Product

Understanding your IVD product’s risk classification is critical to developing your registration strategy. The risk classification specifically defines your regulatory path, review authority, and the required documentation. Below is a breakdown of the general classification categories of IVD reagents:

Class I: Low Risk. Class I IVD reagents require filing only and are therefore not subject to technical review. The most common examples of Class I IVD reagents are those with clearly defined risks and, therefore, have little or no impact on clinical decision-making.
Class II: Moderate Risk: Class II IVD reagents must be registered and require technical review. Most routine diagnostic reagents will fall into the Class II category.
Class III: High Risk: Class III IVD reagents will require strict registration and centralized review by NMPA. The most common examples of Class III IVD reagents are those used for critical diagnosis, screening for infectious diseases, genetic testing, and companion diagnostics.

If you are unsure about your product’s classification, you should seek confirmation from NMPA prior to proceeding.

Appoint a Legal Representative in China

Foreign manufacturers must appoint a legal agent based in China. This agent is legally responsible for:

Submitting registration or filing applications
Communicating with the NMPA
Handling post-market obligations such as adverse event reporting, recalls, and renewals

The legal agent’s responsibilities continue throughout the entire product lifecycle, not only during registration.

In late 2024, the NMPA published a measure to further regulate local agents, requiring that they must be qualified academically and professionally and must sign a commitment letter. Local agents who have been convicted of commercial bribery will be disqualified. Failure to comply with this regulation may lead to exclusion from public reimbursement systems and procurement programs.

Prepare Required Documentation for Registration

Applicants must submit complete, accurate, and traceable technical documentation, including:

Product description and intended use
Risk analysis and risk control measures
Product technical requirements (PTR)
Test reports
Clinical evaluation data (where applicable)
Labeling and instructions for use
Evidence of quality management system (QMS) compliance

Clinical Evaluation Requirements

When Clinical Trials Are Required:

Clinical trials are required to demonstrate safety and efficacy
Exemptions may apply if the principle is well-established, manufacturing is mature, a similar product has safe clinical use, or safety and efficacy can be shown by comparison with a predicate device. The NMPA maintains a catalog of exempted Class II/III IVD reagents

Documentation:

For products that require clinical trials: protocol, Ethics Committee comments, informed consent, trial report, and data
For clinical trial-exempted products: comparative analysis, methodological data, and literature review

Clinical Trial Requirements:

Must follow Good Clinical Practice (GCP) in qualified, registered institutions
Serious adverse events or major safety risks must be reported

Special Considerations:

Consumer-use IVDs must evaluate user comprehension of instructions
For life-threatening diseases lacking diagnostics, investigational reagents may be used ethically on other patients, with safety data supporting registration

Quality Management System (QMS)

Registrants and filing entities are responsible for quality management throughout the entire product lifecycle, including:

Design and development
Manufacturing and quality control
Change management
Post-market surveillance

The NMPA may conduct QMS inspections during registration review or post-approval, especially for higher-risk class II and class III IVD products.

Review Process

During technical review:

Authorities may issue supplementary information requests
Applicants must respond within the specified timeframe
Failure to respond adequately may result in rejection

The NMPA also offers:

Priority review for products addressing urgent clinical needs
Special review pathways for innovative IVD reagents

Post-Market Obligations

Once approved:

IVD registration certificates are typically valid for five years
Changes to product design, manufacturing, or labeling may require:
- Filing of changes, or
- Registration amendment or re-registration

Post-market obligations include:

Adverse event monitoring and reporting
Product recalls when necessary
Cooperation with regulatory inspections
Timely renewal before certificate expiration

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.