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.
February 26, 2024
Approximately 5 minutes
NMPA Clinical Requirements: Clinical Evaluation Reports and Trial Alternatives in China
China NMPA Clinical Trial Requirements and Management
For most Class II and Class III medical devices entering the Chinese market, satisfying the National Medical Products Administration (NMPA) clinical requirements is the most time-consuming and expensive step. Foreign manufacturers must strategically choose their clinical pathway.
📜 Clinical Trial Exemption List
The NMPA maintains a Clinical Trial Exemption List for product types considered technologically mature with proven safety and effectiveness, or where clinical trials are deemed not feasible.
- Benefit: Devices on this list are exempt from full local clinical trials, saving considerable time and cost.
- Requirement: Even with an exemption, manufacturers must still submit a robust Clinical Evaluation Report (CER) to support the device's registration.
🔍 Alternatives to Full Local Clinical Trials
For devices not on the exemption list, manufacturers must choose one of the following primary alternatives to support their application:
- Conduct a Local Clinical Trial: The most direct but often the most expensive and time-consuming option, requiring compliance with China's GCP standards.
- Use Overseas Clinical Data: Manufacturers may submit clinical evidence gathered from trials outside of China. However, this data must strictly meet NMPA's local expectations and often faces challenges regarding comparability to the Chinese patient population and clinical environment.
- Predicate Device Comparison (CER Pathway): This involves identifying at least 3 "Same Type Devices" (predicate devices) already approved in China. The manufacturer must then conduct a thorough comparison of their device to the predicates to demonstrate equivalent safety and efficacy, backed by a comprehensive Clinical Evaluation Report (CER).
📝 The Clinical Evaluation Report (CER)
The CER is a core regulatory document required by the NMPA, whether the device is exempt from trials or relies on the predicate device pathway. A complete CER generally comprises two sections:
- Device-Specific Clinical Evidence: Data collected directly by the manufacturer (e.g., non-clinical studies, usability data, clinical data).
- Literature Review: A systematic review of public information and scientific literature to provide third-party evidence that the device's underlying technology and intended uses are safe and effective.
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
China NMPA IVD Device Registration: Local Testing and Clinical Data Requirements
An outline of the NMPA's regulatory process for In-Vitro Diagnostic (IVD) devices in China, emphasizing the three-tiered classification, the mandatory local NMPA-certified testing, and the requirement for local clinical data for all Class II and III IVDs.
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.