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 3, 2024
Approximately 5 minutes
China NMPA Medical Device Registration: Classification, Legal Agent, and Clinical Data
China NMPA Medical Device Registration and Approval
Medical device market entry 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 renewal applications must be submitted six months prior to expiration. A prerequisite for foreign manufacturers is having home country approval prior to application.
Classification and Regulatory Pathways
The registration pathway depends on the device's risk classification:
| Class | Risk Level | Pathway | NMPA Review Fee (Approx.) | Review Timeline |
|---|---|---|---|---|
| Class I | Low Risk | Filing/Notification | NA | Approx. 4 weeks |
| Class II | Medium Risk | Registration | 210,900 RMB (~$30,000 USD) | 12-24 months |
| Class III | High Risk | Registration | 308,800 RMB (~$44,000 USD) | 12-24 months |
Mandatory Local Requirements
Foreign manufacturers must navigate two critical local requirements:
-
Legal Agent Appointment: A China-based Legal Agent (similar to a Local License Holder) must be appointed. The Legal Agent is responsible for:
- Managing the registration process.
- Providing technical service and maintenance support.
- Assisting with device recalls and adverse event handling.
- Crucially, the Legal Agent controls the MDRC on the foreign manufacturer's behalf.
-
Local Testing and Documentation:
- NMPA-Certified Testing: Product testing certificates must be obtained from a local NMPA-certified laboratory using device samples.
- Language: All information, packaging, and labeling must be translated into Simplified Chinese.
- Home Country Approval: Documentation proving approval in the country of origin (e.g., CE Mark, FDA 510(k)) is required for Class II and III devices.
Clinical Data Requirements
A significant hurdle for Class II and III devices is the requirement for local clinical test data.
- Clinical Trials: Local clinical trials are often required unless the device qualifies for an exemption.
- Clinical Evaluation Report (CER): The NMPA may accept a CER in lieu of a trial if the device qualifies as a "Same Type Device" (predicate device). However, the definition is narrow, making upfront determination difficult. A formal inquiry process exists to seek the performance parameters expected by the NMPA.
Related Articles
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
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.