China’s Medical Device MAH (Marketing Authorization Holder) System: Accelerating Market Access for Foreign Enterprises

In recent years, China’s medical device regulatory framework has been steadily improving, and the formal implementation of the MAH (Medical Device Marketing Authorization Holder) system has provided foreign enterprises with a more flexible market access route. According to data from Qianzhan Industrial Research Institute, the market size of China’s medical device industry reached 1.11 trillion RMB in 2024, with medical equipment accounting for over 60% of the market share. In 2023, the market size of China’s medical device industry was 1.03 trillion RMB, with a five-year compound annual growth rate of approximately 14.67%. This growth trend offers significant opportunities for Italian medical device companies looking to enter the Chinese market. Against this backdrop, the MAH system has become a key strategic option for foreign enterprises to accelerate their market entry into China. This article will analyze the core features of this system, its applicable scenarios, and the specific advantages it offers to Italian enterprises.

1. What is the MAH System?

The MAH system allows the holder of a medical device registration certificate (i.e., the MAH) to outsource the manufacturing process to a qualified medical device manufacturer, even if they do not have their own production capacity. This policy shifts away from the previous model, which required the manufacturing enterprise to hold the registration certificate for the medical device. It enables R&D-focused, innovative, and foreign enterprises to operate more flexibly.

2. Advantages of the MAH Model for Italian Medical Device Companies

For Italian companies planning to enter the Chinese market but unwilling to establish their own factories, the MAH system offers several key advantages:

• Faster Market Access In the past, foreign enterprises needed to establish production entities in China, apply for production licenses, and complete GMP certification, which could take 1-2 years or more. The MAH model allows enterprises to directly outsource production to factories already certified by NMPA (National Medical Products Administration), eliminating the need to build their own factory and significantly shortening the market access cycle.
• Lower Compliance Costs Under the traditional model, enterprises were required to set up a complete quality management system (QMS), covering production, inspection, document management, and various other aspects. With the MAH model, the MAH is only responsible for quality oversight and compliance management, while the production quality system is managed by the contracted enterprise, greatly reducing the cost of establishing an in-house QMS.
• Applicable to Class II and Class III Medical Devices (Including Innovative Medical Devices) In vitro diagnostic (IVD) products, such as ELISA (Enzyme-Linked Immunosorbent Assay), CLIA (Chemiluminescent Immunoassay), and Macroarray technology for advanced diagnostic equipment, require strict production environments and quality systems. By adopting the MAH system, Italian companies can collaborate with existing IVD factories in China that are already certified by NMPA, ensuring compliance with Chinese regulatory requirements while avoiding the high costs of building production facilities.
• Reduced NMPA On-Site Inspections for Overseas Enterprises Import medical device registrations require NMPA to conduct on-site inspections of overseas production enterprises, especially for Class III medical devices. This process is often time-consuming and uncertain. With the MAH system, products are manufactured in China, thus avoiding overseas inspections and improving approval efficiency.

3. Compliance Requirements Under the MAH System

While the MAH model reduces the burden of production management, companies still need to fulfill the following compliance responsibilities:

• Registration Certificate Management The MAH is still responsible for the NMPA registration application and ensuring compliance with Chinese regulations.
• Quality Management (QMS) Supervision Although production is carried out by the contracted enterprise, the MAH must oversee the entire production process to ensure compliance with ISO 13485 and relevant NMPA regulations.
• Adverse Event Monitoring The MAH is required to carry out market monitoring, recalls, complaint management, and other obligations for the product.
• Clinical Evaluation Some products may still need to complete local clinical trials in China or provide clinical data that meets regulatory requirements.

How Can Sino-EU Link Help Italian Enterprises?

As a bridge between China and Italy in the medical industry, Sino-EU Link can provide the following support for Italian medical device companies:

• Regulatory Consulting Helping Italian companies understand China’s medical device regulatory system and develop compliance strategies.
• MAH Service Provider Matching Recommending suitable contracted manufacturing enterprises in China based on the company’s needs.
• Registration Support Providing consulting and project management for NMPA medical device registration, ensuring efficient progress in the registration process.
• Market Access Solutions Developing optimal market entry strategies based on product characteristics, including compliance paths, business models, and potential partners.

The implementation of the MAH system marks a step toward a more international and flexible medical device industry in China. For Italian enterprises aiming to enter the Chinese market, this is a policy tool worth studying and fully utilizing.