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Get seamless market access with Freyr as your China NMPA agent. Freyr represents many global Medical Device company as China Agent for NMPA registration.
Meet our Regulatory Experts
Summer Xia
Associate Director
With over 20 years of experience, including 15 years in medical device regulatory affairs, Summer has excelled in navigating both pre-market and post-market requirements. Her expertise has been instrumental in guiding numerous foreign and local manufacturing companies entering the Chinese market. Summer’s leadership has been demonstrated through her roles heading multinational Quality Assurance and Regulatory Affairs teams. She holds an MBA and is a certified Lead Auditor by BSI, enabling her to proficiently manage complex compliance landscapes.
Layla Tan
Specialist
With over 8 years of experience, including 5 years in the medical device industry, focusing on 2 years in medical device regulatory affairs. Layla has excelled in file submission and preservation both pre-market and post-market. She keep eyes on any change/update from NMPA and provides support for numerous foreign and local manufacturing companies entering the Chinese market.
Allan Zhang
Manager
With 10 years experience of medical device registration. Allan has rich experience in active and non-active medical device, guiding numerous foreign and local manufacturing companies and helping them to get more than 100 certificates approved by NMPA. He had participated in drafting CMDE guideline and industry standards. He can guide manufacture with fast and compliant registration strategy.
Book a meeting
with our regulatory experts today to achieve swift compliance with all China Medical Device regulations.
Frequently Asked Questions (FAQs)
- Regulatory Authority: NMPA (National Medical Products Administration) (formerly CFDA)
- Regulation: State Council Order No.739
- Authorized Representative: NMPA Legal Agent Required
- QMS Requirement: YY/T0287-2017, ISO 13485:2016
- Assessment of Technical Data: Centre for Medical Device Evaluation (CMDE)
- Labelling Requirements: Decree No.6 of CFDA
- Submission Format: eRPS
- Language: English & Chinese
The device classification is defined in the National Medical Products Administration’s (NMPA’s) Medical Device Classification Catalogue (Announcement No. 104/2017), * or/and the rules in Order No. 15 for medical devices. The devices are classified into three (03) classes based on the risk criteria. Class I devices are low-risk devices and Class III devices are high-risk devices.
| Device Class | Risk |
| I | Low-risk |
| II | Medium-risk |
| III | High-risk |
For Medical Device Registration in China, for Class I Medical Devices, record-filing with NMPA is required, and for Class II and Class III, registration certificates from NMPA have to be obtained. Class I devices undergo administrative review, whereas Class II and Class III devices undergo a thorough review process. The data and testing requirements vary based on the availability of predicates. Hence, Class II and Class III device manufacturers should also identify predicates to determine the clinical data requirements for their devices. The NMPA issues Record Filing and Registration Certificates for Class I and Class II/III devices, respectively.
In Summary, for NMPA Registration-
Class I- Registration Dossier and Administrative Review
Class II- Full Registration Dossier and Full Application Review (including technical)
Class III- Full Registration Dossier and Full Application Review (including technical)
The Chinese medical device regulation defines the following registration process for medical device approval in China-
Understanding what is needed for approval in China Medical Device Registration is a challenge because of the complexities laid down by the stringent regulations of NMPA. Whether a device will need a local clinical trial is one of those important questions that manufactures would want to know before registration process. NMPA narrowly defines a predicate, or “Same-Type Device”, which makes it difficult to understand how the device will be evaluated. NMPA publishes annual updates to their Clinical Trial exemption list, and furthermore manufacturers can avoid clinical trials by providing a Clinical Evaluation Report that showcases sufficient comparison to a similar product. For more information on NMPA medical device regulations, contact Freyr today.
