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.
April 26, 2024
Approximately 5 minutes
Predicate Device Identification in China: Navigating the 'Same-Type' Requirement for NMPA Approval
Predicate Device Identification in China (Same-Type Devices)
In China, Predicate Device Identification, locally referred to as 'Same-Type' devices, is a critical regulatory strategy for Class II and Class III medical device manufacturers. Successfully identifying and comparing a device to an already-approved predicate can often exempt the product from costly and time-consuming local clinical trials.
🔍 The Role of Predicate Devices
The core function of identifying a predicate device is to demonstrate the applicant's product is substantially equivalent in terms of safety and efficacy to a device already legally marketed in China.
- Clinical Trial Avoidance: If equivalence can be proven, manufacturers can submit a Clinical Evaluation Report (CER) in lieu of a full clinical trial.
- Narrow Definition: The NMPA maintains a very narrow definition of a "Same-Type Device." Products must share similar technology, the same indications for use, and sometimes even the same raw materials (e.g., a drug-eluting stent must use the same drug in similar quantities as its predicate).
📝 The Clinical Evaluation Report (CER)
The CER is the required document used to support a "Same-Type" device claim. It must include:
- Thorough Comparison: A detailed comparison of the applicant device against the identified predicate device(s) across critical performance, structural, and intended use parameters.
- Clinical Evidence: A summary of clinical and non-clinical data, coupled with a systematic literature review, to prove that the device is safe and effective in the intended clinical setting.
❓ Clarifying NMPA Expectations
Historically, manufacturers faced uncertainty regarding whether their product would be considered "Same-Type" until the formal review began. To improve transparency, the NMPA established a mechanism for pre-submission inquiries:
- Formal Inquiry Process: Manufacturers can seek feedback from the NMPA on the specific performance parameters and data the agency will expect for a Same-Type Device application. This process is designed to reduce the previous turnaround time from approximately six months to about two months, providing essential clarity for regulatory planning.
📜 Clinical Trial Exemption List
While the predicate pathway is a key alternative, the NMPA also maintains an Exemption List for certain product types whose technology is considered mature and has a proven history of safety. Products on this list are automatically exempt from clinical trials but still require the submission of a CER.
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 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
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.