Entering the Chinese medical device market requires compliance with a structured regulatory framework managed by the National Medical Products Administration (NMPA). The NMPA is China’s central authority for medical devices, responsible for market authorization, post-market supervision, and maintaining national technical standards. Its technical evaluation body, the Center for Medical Device Evaluation (CMDE), conducts scientific reviews of all submissions, including initial, renewal, and change registrations.
Prerequisites & Classification of Chinese Medical Device Registration
The prerequisite for most products in China is to have a valid home market product certificate and quality management system, often ISO 13485.
Before applying for medical device registration, manufacturers must confirm the device’s classification and corresponding product code according to NMPA rules.
Devices are divided into Class I, Class II, and Class III, based on risk level and intended use. Determining the correct classification is essential, as it defines the depth of technical documentation and clinical requirements.
For example, Class I devices can often be filed through a record-filing process, while Class II and Class III devices require a full technical review and product testing by accredited Chinese laboratories.
Registration Lifecycle: Initial, Change, and Renewal
The NMPA registration process follows a full lifecycle management system. It includes initial registration, change registration, and renewal (also called extension) every five years.
The initial registration involves dossier submission through the NMPA electronic system, type testing in a qualified Chinese laboratory, and a multi-stage technical review by the CMDE. After approval, a registration certificate is issued and is valid for five years.
During the product’s lifecycle, any modification to the design, dossier or manufacturing process must be assessed to determine whether it qualifies as a change registration. According to NMPA’s change registration requirements, certain updates — such as product name updates, or administrative corrections — can be submitted as administrative changes. However, critical technical or design modifications must go through a formal change review.
Changes considered “significant” include updates to the intended use, fundamental design principles, raw materials, sterilization methods, or major software modifications that impact device performance or safety. Such changes always require NMPA resubmission and new type testing results.
Renewal is mandatory every five years to maintain market authorization. Renewal submissions must demonstrate continued compliance, performance consistency, and any updates in standards or labeling that have occurred during the registration period.
Review Time and Cost of Medical Device Registration
The review time and official costs depend on the device classification and testing requirements. For most products:
- Class II medical devices take approximately 16 – 24 months from dossier preparation to certificate issuance.
- Class III devices, which undergo more complex testing and possible clinical evaluations, typically require 24 – 36 months.
Official review fees, testing fees, and translation costs vary. A detailed breakdown of expected timelines, review stages, and standard government charges can be found here.
Well-prepared technical documentation and early engagement with testing laboratories can significantly shorten review time.
Technical Documentation and Type Testing
The Technical Dossier (TD) is the core submission package under NMPA requirements. It follows a standardized structure that includes device description, intended use, design verification and validation, manufacturing information, quality management documentation, risk management, clinical evidence (or exemption justification), labeling, and after-sales service plans.
A unique aspect of Chinese registration is the type testing process. Unlike many other markets, China generally requires all Class II and III devices to undergo testing at an NMPA-accredited laboratory located in China. The test results form part of the TD and must match the approved Product Technical Requirements (PTR) — a China-specific summary of performance indicators and safety characteristics.
Guidance on how to structure the TD, integrate the PTR, and prepare type testing samples can be found on Chinese Technical Documentation.
Special Routes: Fast-Track and Pilot Zones
To promote innovation and accelerate market access, China has established pilot zones and fast-track pathways for certain devices. These routes are designed for innovative medical devices, urgent clinical needs, or international products entering specific regions with advanced regulatory infrastructure.
Manufacturers that meet the criteria can apply through a special fast-track route for priority evaluation or parallel testing and review, significantly reducing approval timelines. Details and eligibility criteria are described in the fast-track in Chinese pilot zone guide.
A Partnership to Expand Global Regulatory Reach
Product Registration Indonesia is collaborating with EasyChinApproV, based in Germany, to strengthen our global regulatory network for medical device registration.
Through this partnership, Product Registration Indonesia brings its proven expertise in navigating Indonesia’s complex approval process—covering BPOM, MoH, and Halal compliance—while EasyChinApproV provides in-depth knowledge and hands-on experience in China’s NMPA registration system.
Together, we help manufacturers build a seamless compliance strategy across Asia and Europe, ensuring faster market access, mutual recognition of documentation, and a truly global registration roadmap.
