Foreign Medical Device Registration in China

China’s medical and healthcare industry is second only in size to the U.S. on a global scale, The vast growth annually for Chinese medical devices has enjoyed increased expansion across the board and is expected to keep ascending over the next four years, which is largely due to population growth, and the rise in diseases, disorders and a aging society.

China is rapidly becoming a attractive market for foreign medical device manufacturing companies although there are some issues regarding partnerships between foreign manufacturers in regards to distribution of their products across China without foregoing certain aspects of their intellectual property (IP) rights.

Registering for Imported Medical Devices in China

When foreign manufacturers want to import medical devices into China, they need to register their products. It requires a Medical Device Registration Certificate (MDRC) that can only be issued by the National Medical Products Administration (NMPA) which was formally known as the China Food and Drug Administration (CFDA).

The document is controlled by a local Legal Agent although it’s actually owned by the foreign manufacturer in question. However, the legal agent is responsible for the entirety of the application registration process, which means that these foreign medical devices need to be approved before they even attempt to apply for Chinese registration.

What is Medical Device Classification in China?

There is a number of medical device classification categories in China that you need to understand. The first one is the Low-Risk Class I level which is for medical devices that are subject to a filing procedure that must be followed in order to make an application with the NMPA. This process takes approximately 4 weeks to complete from the moment of application submission and is essentially an administrative review and MDRC issuance.

The next classification levels on the list are the Medium Risk Class II and High-Risk Class III categories for medical devices that need to be registered and submitted to the NMPA with an application and some supporting documents. These products need testing certificates that have been issued via a local NMPA-certified lab as a major requirement of the application process. Most Class II and III medical devices require clinical testing data on a local level.

When it comes to the authoritative bodies that are responsible in China for managing imported medical devices from foreign manufacturers, there are three main bodies: the provincial bureau, the municipal bureau, and the NMPA.

At the forefront of this landscape is the NMPA. Established in the late 1990s, the NMPA’s primary role is to ensure the safety, effectiveness, and quality of drugs and medical devices in China. It oversees the entire life cycle of a product, from research and development to post-market surveillance.

Under the NMPA, there are various sub-departments and affiliated institutions responsible for different aspects of the regulatory process. These include the Center for Medical Device Evaluation (CMDE), responsible for evaluating the safety and efficacy of medical devices, and the National Institutes for Food and Drug Control (NIFDC), which conducts testing and research.

In addition to the NMPA and its affiliated institutions, several other bodies play a vital role in the regulatory process. These include the National Health Commission (NHC), responsible for public health and medical administration, and the Ministry of Industry and Information Technology (MIIT), which oversees the manufacturing sector.

To successfully register a medical device in China, manufacturers must engage with these regulatory bodies, understanding their specific requirements, and ensuring compliance at every step of the process.

Foreign manufacturers will have to obtain a license for their medical devices in Class II and Class II categories. This license is better known as medical devices registration certificate. But if the devices are built by a domestic manufacturer, they need two licenses: the production license and the medical device registration license.

Any medical devices that come under Class I will be the responsibility of the foreign manufacturers who need to provide one kind of record, while any domestic manufacturers will need to provide two records that they are responsible for.

Local representation by a Chinese company is required by foreign manufacturers to become the Marketing Authorization Holder (MAH), which is a vital part of submitting a medical device registration.

What Requirements Do Foreign Manufacturers Need?

In the case of medical device companies that are not manufacturers in China, they need to provide samples of the device so the NMPA can perform proper testing.

If they are looking to register devices in Class II and Class III categories, the manufacturers are required to submit documents that prove their device has been tested and approved by the origin country, such as a CE Mark, an ISO 13485 certificate, an approved Premarket Approval Application that has been approved, or a 510(k) letter. Other documentation requirements may also be needed such as any proof of supportive clinical data that needs to be added to the application. Any product data or info on the packaging needs to be translated into Simplified Chinese.

The documentation required for registering a medical device in China can be vast and varied, contingent on the device’s risk classification. Broadly, the documentation encompasses:

Technical File: This outlines the device’s design, manufacturing process, intended purpose, operation mechanism, and safety measures. It’s a comprehensive dossier detailing every aspect of the device from conception to production.

Clinical Evaluation Report (CER): If the device has undergone clinical trials, either in China or abroad, a robust CER is essential. It should encapsulate the trial’s objectives, methodology, outcomes, and an analysis of the results concerning the device’s safety and efficacy.

Risk Management File: A critical component, this file delineates potential risks associated with the device, preventive measures implemented, and strategies to manage any unforeseen adverse events.

Quality Management System (QMS) Documentation: The National Medical Products Administration (NMPA) mandates manufacturers to have a robust QMS in place. This documentation should detail the QMS’s processes, protocols, and standards, ensuring adherence to international quality norms.

Labeling and User Manual: Labeling and user instructions should be provided in Chinese, highlighting the device’s purpose, operation methodology, safety guidelines, and maintenance instructions.

Once the documentation is in place, understanding the sequence of the application can streamline the procedure:

1. Initial Application: Submit an initial application to the NMPA, inclusive of the device’s basic information and an overview of its technical specifications.
2. Document Submission: Post the initial application’s acceptance; submit the comprehensive documentation to the NMPA for detailed review.
3. Technical Review: The Center for Medical Device Evaluation (CMDE) under the NMPA undertakes a rigorous review of the submitted documents, evaluating the device’s technical aspects, safety protocols, and clinical efficacy.
4. Administrative Review: Post the technical evaluation, the documentation undergoes an administrative review. Here, the focus is on adherence to regulatory norms, the comprehensiveness of the information, and the accuracy of translations.
5. Site Inspection: Especially for Class III devices, the NMPA might mandate a site inspection. This is to ensure the manufacturing processes align with the claims in the documentation and meet the prescribed safety and quality standards.
6. Feedback and Revision: The NMPA, after its review, might request additional information or revisions in the documentation. Timely response and meticulous adherence to their feedback can expedite the approval process.
7. Final Approval: Post satisfactory evaluation and any necessary revisions, the NMPA grants final approval, post which the device can be legally marketed in China.

The medical device registration process in China, with its labyrinthine procedures, can seem daunting. However, adopting specific strategies can ensure a smoother journey:

1. Leverage Local Expertise: Engaging local regulatory consultants, familiar with NMPA’s procedures, can offer invaluable guidance. Their insights can optimize documentation, preempt potential roadblocks, and ensure adherence to the latest regulatory updates.
2. Frequent Communication with NMPA: Proactive and transparent communication with the NMPA can clarify doubts, expedite the review process, and foster a collaborative approach.
3. Continual Updates: The regulatory landscape is dynamic. Ensuring that your documentation reflects the latest norms, standards, and protocols is vital to avoid delays.
4. Digital Documentation: With the advent of technology, many regulatory bodies, including the NMPA, are transitioning to digital platforms for document submission and review. Familiarizing yourself with these platforms, ensuring digital compatibility of your documents, and maintaining an organized digital dossier can hasten the process.
5. Feedback Receptiveness: The NMPA’s feedback during the review process is instrumental. Embracing it with a receptive mindset, making necessary revisions promptly, and ensuring transparent communication can expedite the final approval.

The hiring of Chinese-based agents by the foreign manufacturers is a must because they are needed to represent their company interests in China. These agents have a number of tasks to undergo such as being responsible for providing any maintenance support or technical service in regard to the medical device while also assisting in matters related to device recall if required. The agent also needs to help oversee the registration process and also ensuring there is support in the event of a medical device malfunction.

Clinical Trials & Evaluation in China

The clinical trials and evaluation process for medical devices in China is a pivotal stage for ensuring the safety and efficacy of devices entering the market. In this chapter, we will provide an in-depth understanding of the intricacies involved in these evaluations, their significance, and strategies to effectively navigate them.

Clinical trials are designed to test the safety and effectiveness of a medical device in real-world conditions, with real patients. They are an essential bridge between laboratory research and the device’s introduction to the market. China, like many countries, places a significant emphasis on rigorous clinical testing, especially for devices that carry a higher degree of risk to patients.

Not all devices require clinical trials in China. Whether a trial is necessary depends on several factors:

1. Risk Classification: As previously mentioned, devices are classified into three categories in China – Class I (low risk), Class II (medium risk), and Class III (high risk). While Class I devices seldom require clinical trials, Class III devices almost always do. Class II devices may or may not need trials, depending on their complexity and potential risk.
2. Existing Data: If there’s substantial clinical data available from trials conducted internationally, and these trials align with China’s standards, the National Medical Products Administration (NMPA) might waive the need for additional local trials. However, this data must be comprehensive, recent, and applicable to the Chinese population.
3. Device Novelty: Novel devices, or those introducing new methodologies or technologies, are more likely to require clinical trials due to the unfamiliarity of their risk profile.

Should your device require a clinical trial in China, here’s what the process generally involves:

1. Trial Approval: Before commencing the trial, approval must be obtained from the NMPA. This involves submitting a detailed plan of the trial design, methodologies, patient selection criteria, and safety measures.
2. Selecting Clinical Trial Institutions: Trials must be conducted at institutions approved by the NMPA for such purposes. These institutions have the necessary infrastructure, expertise, and oversight mechanisms to conduct medical device trials.
3. Patient Consent: Ensuring informed consent from all participants is mandatory. They should be aware of the device’s nature, the trial’s purpose, potential risks, and their rights.
4. Trial Monitoring: Trials are closely monitored for adherence to protocols, patient safety, and data integrity. Regular reports must be submitted to the NMPA, detailing progress, any adverse events, and interim results.
5. Data Compilation & Submission: Post the trial’s conclusion, data must be compiled systematically and submitted to the NMPA as part of the Clinical Evaluation Report (CER). This data forms the crux of the device’s safety and efficacy evaluation.

In scenarios where clinical trials are deemed unnecessary, a robust Clinical Evaluation Report (CER) still needs to be submitted. This report should:

1. Detail existing clinical data, including its source, methodology, and results.
2. Analyze this data in the context of the device’s safety and efficacy.
3. Highlight any adverse events or complications noted in previous trials or post-market surveillance.
4. Provide a rationale for why local trials in China are deemed unnecessary, backed by comprehensive data.

Post-Market Surveillance & Maintenance of Registration

Even after successfully registering a medical device in China, the journey doesn’t conclude. Post-market surveillance (PMS) is the continuous monitoring of medical devices after they have been introduced to the market. This ensures the ongoing safety and effectiveness of the devices, addressing any issues that may arise once they are in widespread use. This chapter will delve deep into the intricacies of PMS, the importance of maintaining the registration, and the necessary steps involved.

PMS is crucial for several reasons:

1. Detecting Rare Issues: Clinical trials, while rigorous, often involve a limited number of participants. Certain adverse events might only become evident when the device is used in a broader population.
2. Monitoring Long-Term Effects: Some complications or device failures might not manifest immediately but could become evident after prolonged use.
3. Feedback for Improvement: Continuous monitoring provides manufacturers with valuable feedback, allowing them to refine and improve their products over time.
4. Upholding Trust: Regular PMS demonstrates a company’s commitment to patient safety, fostering trust among healthcare professionals and patients.

In China, the post-market surveillance system is structured and comprehensive, involving:

1. Adverse Event Reporting: Manufacturers are obligated to report any adverse events or device malfunctions they become aware of. This includes not just events occurring in China but globally.
2. Periodic Safety Update Reports (PSURs): These are scheduled reports detailing the safety and performance of the device in the post-market phase. They encompass all data, from clinical studies to real-world usage.
3. Post-Market Clinical Follow-ups (PMCF): In certain scenarios, especially for high-risk devices, the NMPA mandates PMCFs. These are essentially extended clinical studies to continually evaluate the device’s safety and effectiveness in real-world settings.
4. Device Tracking: For certain high-risk devices, a robust tracking system might be required. This ensures that if issues are identified, affected devices can be quickly located and managed.

While registering the device is a significant milestone, maintaining that registration is equally crucial. This involves:

1. Renewal of Registration Certificate: The registration certificate, once granted, has a validity period. Manufacturers need to apply for renewal before it expires, ensuring uninterrupted market access.
2. Update of Information: Any significant changes to the device, be it in design, function, or manufacturing processes, need to be reported to the NMPA. Depending on the nature of the change, a re-evaluation might be needed.
3. Regular Quality Audits: The NMPA, in collaboration with provincial agencies, might conduct regular quality audits of the manufacturing facilities. Ensuring continual adherence to quality standards is essential to maintain the registration.

Navigating post-market requirements can be challenging, but certain strategies can facilitate smoother processes:

1. Establish a Local Team: Having a team on the ground in China, focused on PMS, can be invaluable. They can quickly address issues, liaise with the NMPA, and ensure timely compliance with all requirements.
2. Invest in Robust Reporting Systems: Implement systems that can promptly detect, document, and report any adverse events. Time is often of the essence, and delays can have regulatory and reputational repercussions.
3. Engage with Healthcare Professionals: Regularly engage with doctors, nurses, and technicians using your device. Their feedback can offer early warning signs of potential issues and provide insights for improvement.
4. Regular Training & Updates: Ensure that all stakeholders, from sales representatives to technical support teams, are regularly trained. They should be updated about any changes to the device, its usage protocols, or safety guidelines.
5. Stay Abreast of Regulatory Changes: The regulatory landscape is dynamic. Regularly review any updates to the NMPA’s guidelines on PMS and ensure compliance.

Labeling and Packaging Regulations

In the world of medical devices, how a product is presented isn’t just about aesthetics or branding. Labeling and packaging are critical components, ensuring user safety, product integrity, and regulatory compliance. China, with its meticulous regulatory framework overseen by the National Medical Products Administration (NMPA), has stringent standards for labeling and packaging.

A distinct feature of the Chinese medical device market, which sets it apart from many others, is the language requirement. All medical devices sold in China must have labels in simplified Chinese. While this may seem like a mere translation task, it has deeper implications.

Manufacturers must ensure that the translation is not just linguistically correct but also contextually appropriate. Medical terminologies, indications, contraindications, and instructions can have nuanced differences across languages. A direct translation might not always capture the essence or specificity required for medical devices. Consequently, relying on professional translators with expertise in the medical field becomes imperative.

This focus on Mandarin is rooted in a commitment to ensure that every healthcare professional, regardless of their proficiency in English or any other language, can fully comprehend the device’s usage, benefits, and risks. In a 2019 study, it was revealed that a significant number of medical errors in global markets can be attributed to labeling misunderstandings, emphasizing the importance of clear and understandable labels.

Foreign medical device registration can be very complicated and fraught with potential issues that can cost time and money. Having someone on your side in China to ensure everything runs smoothly and above the law is not just helpful, but absolutely essential. We can help you to obtain the proper regulatory approval for any medical devices in China.

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