China's Medical Device Master File System: Facilitating Market Entry for Global Manufacturers

Effective from the implementation of China’s medical device master file registration system, international manufacturers are now able to submit detailed technical documentation related to raw materials through an authorized domestic agent, also known as the NMPA Legal Agent. This allows their information to be referenced in medical device product registration, change applications, or clinical trial submissions, while maintaining confidentiality. The system facilitates more efficient regulatory review processes and enables international stakeholders to align with local requirements, offering a structured route to market entry in China.

Medical Device Master Files: Introduction

China's medical device master file system, or MDMF for short, allows manufacturers to submit proprietary technical details—such as raw material composition, manufacturing processes, and biocompatibility data—directly to the regulatory authority for secure archiving. These documents become available for reference during the evaluation of related device registration applications, without disclosing sensitive content to third parties.

The master file framework not only supports the protection of intellectual property but also streamlines the technical review process. It enables regulators to assess core material and safety data independently of the product applicant, improving review efficiency and regulatory transparency. As the demand for high-quality medical devices increases in China, this system has become integral to facilitating safe and compliant market access.

Master File Registration Process

• Voluntary Application: The registration of medical device master files is based on the principle of voluntariness. Domestic owners of master files may apply for registration independently, while owners of imported master files (including those from Hong Kong, Macau, and Taiwan regions) are required to entrust a domestic agency – also known as the NMPA Legal Agent - to apply for registration on their behalf. The master file owner must ensure that all registration documents are signed and sealed by themselves. This includes the medical device master file registration (update) application form and the accompanying registration and technical documents. If the documents are in a foreign language, a Simplified Chinese translation must also be provided. The translation may be signed and sealed by the NMPA Legal Agent.

• Digital Certification and Document Submission: The owner of the master file or their NMPA Legal Agent must obtain a digital certification certificate (CA) compatible with the eRPS system. Subsequently, in the electronic submission system, they must submit the medical device master file registration application form, the registration documents accompanying the application form, technical documents, and other registration materials. For example, raw material master file documents may include descriptions of raw material components, physical property research documents, chemical property research documents, and biological evaluation documents/toxicological risk analysis documents. These documents should be provided in accordance with the requirements for medical device/in vitro diagnostic reagent registration and submission documents, as well as relevant guidance principles.

• Registration Receipt and Information Disclosure: Upon successful submission of the documents, the National Medical Products Administration's Medical Device Technical Review Center (hereinafter referred to as the Review Center) will issue a medical device master file registration receipt to the master file owner or their NMPA Legal Agent. The registration receipt merely serves as proof that the master file is archived and available for reference in matters such as medical device product registration. The Review Center will disclose relevant master file registration information on its official website at an appropriate time to facilitate public inquiries.

• Associated Review: The Review Center will only conduct a review of the master file documents after a related medical device has submitted a registration application. When a medical device registration applicant needs to use the master file documents in their product listing registration application, the master file owner must issue an authorization letter to the medical device applicant. The medical device applicant will include this authorization letter as part of their submission documents, in lieu of the registered master file documents. During the review process, the regulatory authority will access the registered master file documents based on the authorization letter for evaluation.

Implications for Overseas Manufacturers

For international raw material and component, as well as for medical device manufacturers seeking to enter the Chinese market, the MDMF system presents new opportunities. On the one hand, it enables raw materials and component manufacturers a clear pathway to support their medical device customers in China whilst protecting their intellectual property. As long as they prepare and submit the master file in accordance with requirements, they have the opportunity to obtain approval for their products and gain entry into this vast market. On the other hand, the complex document preparation and stringent regulatory requirements also pose higher challenges for manufacturers.

International manufacturers need to invest additional time and resources to ensure the compliance of their master files. This may involve adjusting existing production processes and quality management systems, as well as conducting in-depth research and understanding of the regulations. However, the rewards for overcoming these challenges are substantial. The demand for high-quality medical devices in the Chinese market continues to grow, and manufacturers who successfully enter and establish a foothold in the market will gain significant market share and business opportunities.

Cisema's Services: Professional Support for MDMF

As a professional regulatory consulting service provider, Cisema is well aware of the difficulties and needs faced by international manufacturers when dealing with China's medical device master file registration system. We have a team of experienced professionals who are familiar with China's medical device regulations and international standards, and we can provide comprehensive support to manufacturers.

1. Regulatory Interpretation and Consulting Services

• Cisema has a professional regulatory team that conducts in-depth research on China's medical device policies. We can provide international manufacturers with detailed interpretations of the various requirements of the medical device master file registration system. This includes the scope of application, registration process, key points for document preparation, update requirements, and more. We help companies accurately understand the implications of regulations to ensure that their decisions and actions comply with regulatory provisions.

2. Acting as NMPA Legal Agent in China and assisting with the MDMF Registration Process

• From applying for a digital certification certificate (CA) to submitting registration documents in the electronic submission system in the role as NMPA Legal Agent, Cisema can provide full assistance to overseas manufacturers. We help businesses prepare complete and compliant registration documents, ensuring the accuracy and timeliness of document submission, and improving the success rate of registration applications. During the registration process, we promptly address issues encountered by companies and handle communications with the review NMPA Legal Agent.

3. Subsequent Change Management

• When changes occur in the master file content, Cisema assists companies in submitting update applications. We help businesses organize the changes, prepare the complete set of updated master file documents and explanations of the changes. Additionally, we guide companies in promptly notifying relevant medical device registrants and assist in assessing the impact of the changes on the safety and effectiveness of the medical device products. We ensure that companies can take appropriate measures in accordance with regulatory requirements, such as conducting registration changes.

Further Information

To read the formal announcement by NMPA’s CMDE with the list of registered master files, please click here.

If you are a medical device manufacturer with questions about how to submit a master file or authorize its use in China’s registration process, please contact Cisema.

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