With the emergence of new technologies, the discovery of new biomarkers and new therapeutic targets, the IVD market of China is expanding quickly. The market size of the IVD market in China has grown from 6.6 billion US dollars in 2015 to 18.2 billion US dollars in 2021 (excluding COVID-19 testing)
With continually evolving regulations, the regulatory landscape pertaining to IVD products in China is complex. Although China NMPA (CFDA) is making an effort to be more consistent with international standards and practices, obtaining approvals in China is still a great challenge for international IVD/CDx manufacturers.
IVD Regulatory Landscape in China
General Introduction
China regulates IVD products, including instrumentation platforms, related software and IVDreagents, as medical devices. IVD reagents are also regulated under the regulations specifically for IVD reagents products. In addition, IVD reagents used for blood screening and those labeled by radionuclide are regulated as drugs in China.
Same as FDA, NMPA categorizes medical devices into one of three classes – Class I, II, or III – based on their risk levels. According to Decree No. 739, Class I medical devices are subject to filing administration, Class II and Class III medical devices are subject to registration administration. IVD products can be found in all three classes. See LINK Refer here for a general introduction of regulatory landscape of medical devices in China.
IVD Guidelines and Standards
With continued effort, NMPA has established a relatively complete regulatory system for IVD products. By the end of 2022, NMPA had published 154 guidelines for IVD products in total (115 for IVD reagents, 19 for IVD instruments, and 30 for others). In China, IVD products also need to meet the requirements of applicable national and industrial standards. There are currently more than 300 IVD product standards in China.
Clinical Evaluation of IVD Reagents
- Clinical Trial Exempt Catalogue
According to “Provisions for In-vitro Diagnostic Reagent Registration and Filing” published by NMPA, clinical trials are not required for Class II or Class III IVD reagents, if they are on the NMPA clinical trial exempt catalogue the applicant can perform a comparison study with NMPA-approved similar/equivalent products to establish a substantial equivalence of their IVD reagent to them. Or the applicant can compare their products to a well-established and accepted reference procedure/golden standards (if any) to demonstrate the consistency. The current version of “Clinical Trial Exempt Catalogue of IVD reagents” was published by NMPA in 2021.
- Overseas Clinical Trial Acceptance
For Class II and III IVD reagents that are not on the NMPA clinical trial exemption catalogue, clinical trial data are required for product registration. The Overseas Clinical Trial (OCT) data pathway can be considered as an alternative to a China local clinical trial if certain criteria can be met. In addition to the basic requirements on the documents (clinical trial protocol, ethical opinions, clinical study report, raw data related material), the applicant needs to perform the gap analysis between the overseas clinical trial and a China local clinical trial in terms of GCP requirements, number of clinical trial institutions, people who perform the test, comparator, sample size, ethnic difference etc. It is understood that there will be differences between the China local clinical trial and an overseas clinical trial. The key is to prove that the differences can be justified that they will not affect the clinical trial results. The applicant needs to demonstrate that the clinical data obtained from overseas trials are also applicable to the Chinese population.
How can we help?
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
- IVD comparison studies
- 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 (PMS)
To unlock the IVD/CDx China market, please contact us at info@chinameddevice.com
