Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
ElendiLabs
Hong Kong
ElendiLabs specializes in medical device regulatory affairs in Hong Kong, providing comprehensive support for MDACS registration and compliance.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
CMIC Holdings Co., Ltd.
Tokyo, Japan (HQ), Osaka, Japan, Beijing, China, Seoul, South Korea, Taipei, Taiwan, Singapore, New York, USA, London, UK, Frankfurt, Germany, Sydney, Australia
We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.
January 5, 2024
Approximately 5 minutes
China NMPA IVD Device Registration: Local Testing and Clinical Data Requirements
NMPA IVD Device Registration in China
Registration and importation of In-Vitro Diagnostic (IVD) devices in China requires a Medical Device Registration Certificate (MDRC) issued by the National Medical Products Administration (NMPA). The MDRC is valid for five years, and the application process requires prior home country approval.
Classification and Pathways
IVD devices follow the same three-tiered classification structure as general medical devices, with the pathway determined by risk:
| Class | Risk Level | Pathway | Review Timeline |
|---|---|---|---|
| Class I | Low Risk | Filing/Notification (eRPS) | Approx. 4 weeks |
| Class II | Medium Risk | Registration | 12-24 months |
| Class III | High Risk | Registration | 12-24 months |
Key Local Requirements
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Legal Agent: Foreign IVD manufacturers must appoint a China-based Legal Agent. This agent is the entity responsible for submitting the registration application, maintaining compliance, and officially controlling the MDRC.
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Local Product Testing: For Class II and Class III IVDs, a mandatory component of the application is the submission of product testing certificates issued by a local NMPA-certified laboratory. Device samples must be provided for this testing phase.
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Local Clinical Data: A crucial requirement for IVDs is the submission of local clinical test data for all Class II and Class III devices. This data must support the claimed safety and effectiveness of the IVD in the Chinese population. The NMPA provides guidelines and an exemption process for clinical data, but local testing remains a significant hurdle.
Related Articles
Approximately 5 minutes
China NMPA Medical Device Registration: Classification, Legal Agent, and Clinical Data
An essential guide to securing a Medical Device Registration Certificate (MDRC) from China's NMPA, detailing the three-tiered classification, the mandatory role of the China-based Legal Agent, required local testing, and the strict clinical data requirements.
Approximately 5 minutes
NMPA Clinical Requirements: Clinical Evaluation Reports and Trial Alternatives in China
A guide to navigating China's stringent NMPA clinical requirements, focusing on the Clinical Trial Exemption List, the use of Clinical Evaluation Reports (CERs) as a core submission, and the alternatives to performing costly local clinical trials (e.g., predicate device comparison).
Approximately 5 minutes
NMPA Regulation of Stand-Alone Medical Software (SaMD): AI, Cloud, and Data Requirements
An overview of China's regulatory framework for Stand-Alone Medical Software (SaMD), covering classification (Class II/III), specific requirements for AI and Cloud storage (must use a Chinese provider), and the need to establish compliant local patient databases.
Approximately 5 minutes
Predicate Device Identification in China: Navigating the 'Same-Type' Requirement for NMPA Approval
Predicate device identification (or 'Same-Type' comparison) is crucial for Class II/III devices in China to potentially avoid costly local clinical trials, requiring manufacturers to demonstrate equivalence in technology, indications, and performance via a Clinical Evaluation Report (CER).
Approximately 5 minutes
China's National Medical Products Administration (NMPA): Regulatory Body and Recent Reforms
The NMPA is China's national regulatory body for medical devices, IVDs, and drugs. Since changing its name from CFDA in 2018, the NMPA has focused on international alignment, improving review transparency (e.g., Clinical Trial Exemption Lists), and streamlining processes.