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.
March 11, 2024
Approximately 5 minutes
NMPA Regulation of Stand-Alone Medical Software (SaMD): AI, Cloud, and Data Requirements
China NMPA Regulation for Stand-Alone Medical Software (SaMD)
In China, Stand-Alone Medical Software (SaMD) is explicitly regulated as a medical device. The registration process is governed by the Medical Software NMPA Registration Guidance (No.50, 2015), with additional guidelines for modern technologies like AI.
💻 Classification and Regulatory Scope
SaMD is classified based on its intended use, typically falling into Class II or Class III risk levels. As with hardware devices, higher classification implies more rigorous testing and clinical requirements.
- Cybersecurity: All SaMD must comply with the Medical Device Cybersecurity Guidance (2017), ensuring the software is protected against threats that could affect its function or data integrity.
💡 Special Requirements for AI and Cloud Services
The NMPA has implemented specific rules to address emerging software technologies:
- AI-Aided Software: Software that uses Artificial Intelligence (AI) is subject to the “Technical Guideline on AI-Aided Software” (2019). A primary regulatory obstacle for foreign AI products is the difficulty in collecting Chinese patient information and establishing a compliant local database, which is necessary for model validation and approval.
- Cloud Storage: If the SaMD utilizes Cloud storage services, the Cloud service provider must be a Chinese company to meet data residency and security regulations.
🏷️ Labeling and Distribution
The labeling requirements for non-physical SaMD are similar to those for physical devices, but with a specific focus on technical detail:
- Electronic Labeling: Labels can be provided electronically and made available online.
- Clarity on Interfaces: The label must clearly specify the technical characteristics and usage restrictions of key software interfaces.
Distribution License: Any Chinese distributor invoicing hospitals for the SaMD must hold a Medical Device Distribution Business License (医疗器械经营许可证).
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
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.