China
Our expertise on China market access will accelerate your time to market.
Get to market in China, fast
As an MD or IVD manufacturer, entering the Chinese medical device market requires navigating stringent NMPA regulations, including device classification (Class I–III), local product testing, potential clinical trials, and the mandatory appointment of a China Agent for registration, surveillance, and adverse event reporting. Imported devices face significant review timelines (1–2 years for Class II/III) and require renewal management every five years. Class I device approval is faster but complicated.
Our team combines in-depth knowledge of NMPA regulatory pathways, local test houses, and agent requirements to streamline your China market entry. We manage everything while serving as your trusted China Agent to ensure fast, effective communication and reduce operational burden.
With our multilingual regulatory experts based in Nanjing and Bejing, our consultants have helped many venture startups and multiple national corporations in China and abroad with China Medical Device Regulations successfully obtain regulatory approval with the NMPA registration process since 2011.
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Discover how we can help:
China Market Access (NMPA Registration)
Regulatory pathway classification, technical dossier preparation, local product testing, clinical evaluation reports, or clinical-exemption pathways.
China Agent (NMPA Legal Representation)
We submit registrations, handle post-market surveillance and adverse event reporting, liaise with the NMPA, and maintain your legal credentials on official documents.
Training on NMPA requirements (e-learning)
• Medical device governing body
• Classification
• Registration and filing
• Domestic and imported devices
• In-country representation
• Certificate validity and renewal
• QMS requirements
Fast-track submission options
Clarify the gaps between China's requirements and other countries. There are several fast-track routes within the NMPA program; we help you determine applicability.
Market access to China, with language, culture, and compliance differences, could be challenging and require knowledge and support. Without proper guidance, market approval will be delayed.
With our multilingual regulatory experts based in Nanjing and Bejing, our consultants have helped many venture startups and multiple national corporations in China and abroad with China Medical Device Regulations successfully obtain regulatory approval with the NMPA registration process since 2011.
By working directly with the China Health Authority and maintaining regular contact with local test engineers, authority officers, and technical reviewers, our regulatory experts are fully aligned with regulatory compliance, able to identify gaps, find solutions, and provide you with one-stop service support until the certificate is obtained.
Are you ready for China market approval?
By working directly with the China Health Authority and maintaining regular contact with local test engineers, authority officers, and technical reviewers, our regulatory experts are fully aligned with regulatory compliance, able to identify gaps, find solutions, and provide you with one-stop service support until the certificate is obtained.
Couldn't find your question?
Why is China an attractive market for medical devices and in vitro diagnostics?
Due to the large base population and growing aging population, China is a compelling healthcare market and presents numerous opportunities for foreign companies. Although Europe and the US are the two biggest markets, China has become a new force with a rising growth rate. Compared with the development of pharmaceuticals and the market share of imported drugs, the medical device sectors still have enormous potential for development. In particular, the products with high technical barriers or innovative devices have no replaceable domestic products.
What are the significant challenges for foreign applicants to enter the Chinese market?
Understanding the practicalities of accessing the Chinese market is key. The regulatory environment is complex and dynamic because of the ongoing introduction of new/revised requirements. Devices with artificial intelligence are at the forefront of cybersecurity and data protection and are thoroughly monitored. Also, the language barrier and the cultural differences play a role and require knowledge and support. The overall business acumen requires you to have well-established relationships with local parties.
Why is it essential to establish a global strategy early on for entering multiple markets?
Although you’re not planning to enter different markets at once, if you consider them in your global strategy, this will be beneficial afterward. If you know the requirements from the start, you don’t have to start over with the design process at a later stage. And you made an efficient move by properly organizing comparable processes, which are similar in other countries.
Qserve helps build a customized global approach and creates an efficient manufacturer roadmap. The roadmap includes the global registration strategy, which considers country-specific regulations/guidelines/ standards in the early product R&D phase, and the expedited route, which leverages reference country technical documentation and approved certificates. It also addresses the type-testing requirements and clinical study plan, with a reasonable number of country-based subjects to justify the race or clinical practical differences.
What is the role of the NMPA (National Medical Products Administration) in China?
In China, the National Medical Products Administration (NMPA) is crucial in overseeing and granting licenses for pharmaceuticals, medical devices, in vitro diagnostics, and cosmetics. Here's an overview of the key responsibilities undertaken by the NMPA:
Safety Supervision: The NMPA ensures the safety of drugs, medical devices, and cosmetics. This involves devising regulatory policies, laws, and norms, and monitoring their implementation. Additionally, the NMPA researches to develop supportive policies that foster the advancement of new technologies and products in these sectors.
Standards Management: The administration manages drug, medical device, and cosmetic standards. It oversees the development of the Chinese Pharmacopoeia and other relevant standards. The NMPA also establishes classification systems and ensures adherence to these standards.
Registration Regulation: The NMPA regulates the registration process for drugs, medical devices, and cosmetics. This includes designing registration management systems, conducting technical reviews for certification, streamlining approval processes, and overseeing implementation.
Quality Management: The NMPA prioritizes quality assurance for drugs, medical devices, and cosmetics. It sets guidelines for Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and Good Distribution Practices (GDP) and provides guidance for their implementation.
Post-Market Risk Management: The NMPA manages risks associated with drugs, medical devices, and cosmetics after they enter the market. This involves monitoring, evaluating, and addressing adverse events. In cases of emergencies, the NMPA implements appropriate measures under the law. Supervision and Inspection: The administration organizes and guides the supervision and inspection of drugs, medical devices, and cosmetics. It establishes inspection protocols and investigates and acts against illegal activities during registration and manufacturing processes.
International Collaboration: The NMPA engages in international exchange and cooperation regarding the regulation of drugs, medical devices, and cosmetics. It actively participates in developing international regulatory rules and standards, ensuring alignment with global best practices.