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.
May 22, 2024
Approximately 5 minutes
China's National Medical Products Administration (NMPA): Regulatory Body and Recent Reforms
China's National Medical Products Administration (NMPA)
The National Medical Products Administration (NMPA) is the national regulatory body in China responsible for the oversight of drugs, cosmetics, and all medical devices, including In-Vitro Diagnostics (IVDs). Formerly known as the China Food and Drug Administration (CFDA), the organization was renamed in 2018. The NMPA is based in Beijing and is the key competent authority for issuing the mandatory Medical Device Registration Certificate (MDRC) for foreign products.
Strategic Goals and International Standing
The NMPA is actively working to establish itself as an internationally recognized regulatory body.
- International Alignment: The agency is continually updating its standards and regulations to align with global best practices and expectations.
- Reference Country Status: Currently, NMPA approval is generally not recognized by most countries as a Reference Country for expedited review pathways. However, this is expected to change as the NMPA's standards evolve, which would significantly benefit local Chinese manufacturers and early market entrants in Asia.
Significant Regulatory Reforms
In recent years, the NMPA has implemented several updates aimed at increasing efficiency and transparency in the registration process:
- Clinical Trial Clarity: Increased transparency regarding clinical requirements through the publication of Clinical Trial Exemption Lists and the provision of guidelines for Clinical Evaluation Reports (CERs).
- Classification Guidance: Providing more official feedback routes and classification guidance before manufacturers formally submit their applications.
- Process Improvements: Notable improvements in overall registration review times and the simplification of the process for transferring product licenses from one Legal Agent to another.
- Electronic Submissions: Implementation of the Electronic Regulated Product Submission (eRPS) system for new and renewal applications.
Regulatory Documentation
The NMPA regularly issues compulsory standards, draft guidance documents, and new regulations on its official website, which are essential reading for manufacturers seeking market access in China.
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
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).