China NMPA Medical Device Registration Services
Get your medical devices approved for the Chinese market with expert support across testing, clinical evaluation and China clinical trials, NMPA registration submissions, and agency interactions. Cisema helps international manufacturers navigate regulatory requirements, manage each stage of the medical device registration process, and move toward market entry with a clear regulatory strategy.
Cisema's China Medical Device Registration & Filing Services
We guide you through every step of the China medical device registration process. We take care of compliance with NMPA requirements, advising you on the optimal market entry pathway, test methods and helping you through the whole process to achieving your medical device registration certificate.
Our services include:
- Predicate devices
- Overseas clinical data
- NMPA standard filings for class I & registrations for class II and class III devices
- NMPA Innovative Medical Device route
- Hainan Medical Tourist Pilot Zone
- Greater Bay Area Approvals (requiring prior Hong Kong Listing)
- NMPA Priority Review
- Emergency Approval
- Conditional Approval
Medical Device Post-Market Surveillance Services in China
Cisema supports medical device and IVD manufacturers in China with post-market surveillance and vigilance activities, helping identify emerging safety risks and maintain ongoing compliance with NMPA requirements throughout the product lifecycle.
Adverse Event Monitoring & Vigilance
Periodic Risk Evaluation & Reporting
Risk Management & Corrective Action
PMS Compliance & QMS Integration
China NMPA Medical Device Risk Classification
The approval process, whether a registration or filing/notification, depends on the device’s risk classification, which is determined by the NMPA’s Medical Device Classification Catalogue, and is updated every year or so. If a product is not listed in the catalogue, manufacturers can refer to the "Rules for Medical Device Classification" or request an official classification from the NMPA.
Class I Medical Devices
Manufacturers must submit a filing or notification application with technical information, test reports, and quality documentation. Upon approval, the device is listed in the NMPA database, and a Certificate of Filing is issued with indefinite validity unless modified.
Class II & III Medical Devices
Manufacturers must submit a registration application. These devices require local type testing, either a local Clinical Trial or a China compliant Clinical Evaluation Report (CER), and a Quality Management System review.
NMPA Legal Agent Requirements for Foreign Manufacturers
To register medical devices in China, foreign manufacturers must first appoint a local NMPA Legal Agent to act as their representative throughout the product lifecycle. (NMPA stands for the National Medical Products Administration, which is China’s regulatory authority responsible for medical devices).
Explore Related China Medical Device Services
Whether you’re just starting out or are a blue-chip, access our wide range of services and solutions to help your business thrive.
NMPA Legal Agent
We are your authorized representative in China, and fulfill your registrations and filings as well as ensuring compliance with quality and PMS requirements.
NMPA Type Testing
We provide end-to-end support for China type testing in NMPA-accredited laboratories. Our experienced test engineers offer on-site supervision to guarantee accurate and reliable results.
China Clinical Trials
You may be required to provide supplementary clinical data on Chinese patients or conduct a full clinical trial in China.Our clinical research team will advise you, prepare the study protocol and assist setting up the clinical trial in China.
NMPA Clinical Evaluation Report
CERs can avoid the need for a China clinical trial in some instances. Our experts can advise and prepare NMPA compliant CERs.
Drug Device Combination Products
We assist with the classification, registration, and compliance of combination products in China, whether drug or device led.
China Medical Device Quality Compliance
We help you achieve and ensure ongoing compliance with Chinese requirements.Our experts prepare and assist you for official NMPA inspections.
Medical Device PMS & Vigilance
The NMPA is placing greater focus on Post-Market Surveillance (PMS) such as more in-market sampling inspections and regular standard changes.
Regulatory Outsourcing
If you are seeking specific specialist expertise or have ongoing resource-intensive needs, we have a variety of solutions to meet your needs.
China Medical Device Registration FAQs
Timelines and costs depend on classification, testing, clinical evidence and dossier readiness. For planning, imported Class II devices typically take around 18 months and Class III around 21 months when no local clinical trial is needed. These are overall estimates, rather than statutory technical-review periods. Cisema can assess the requirements and prepare a product-specific registration plan and budget.
Yes. Overseas manufacturers need a China-based legal agent for applicable imported-device registrations and post-market obligations. A distributor may fill the role, but this can complicate future distributor changes and access to regulatory documentation. Cisema provides independent NMPA legal-agent services, registration support and post-market surveillance, helping you separate regulatory responsibilities from distribution.
Not necessarily. Class II and III devices generally need clinical evaluation, but eligible devices may be exempt or supported by equivalent-device comparisons and existing clinical data. Local trials are more often needed for high-risk or novel devices. Cisema can assess the clinical-evidence pathway and support Chinese trials where required.
CE marking and FDA clearance do not replace NMPA registration. Imported Class II and III devices generally need country-of-origin marketing approval, with exceptions for certain innovative devices. Existing technical and clinical data must meet Chinese standards, format and language requirements. Cisema can assess your dossier, identify gaps and adapt it for NMPA submission and related regional registrations.
Class II and III registration certificates are valid for five years, and renewal should be filed at least six months before expiry. Registrants must maintain a quality management system, monitor and report adverse events, submit annual quality system self-inspection reports and file changes to the registered device or manufacturer. Cisema supports post-market surveillance, change filings and renewals alongside its agent services.
NMPA's revised GMP replaces the 2014 version on 1 November 2026 and covers registrants, filers and contract manufacturers across the lifecycle, from design to after-sales service. Manufacturers with ISO 13485 systems should typically expect gaps around registrant responsibilities and supplier control. A gap assessment now helps avoid findings in registration quality-system reviews and inspections. Cisema provides ISO 13485 and China GMP adaptation and inspection-readiness support.
