Testing Services for China NMPA Requirements

Based on the National Medical Products Administration (NMPA), China is the world’s 2nd largest medical devices market. All Class II and Class III medical devices need to be approved by the NMPA to enter China market. The product categories that are subject to NMPA approval include:

• Imaging medical devices.
• Surgical Robotics.
• Respirator & Ventilator.
• Electrophysiological diagnosis and monitoring devices.
• Cardiac rhythm management devices.
• Implantable neuroregulatory management devices.
• High-frequency, radiofrequency surgical devices.
• Ultrasonic surgical devices.
• Infant care devices.
• Dialysis, extracorporeal circulation devices.
• In vitro diagnostic (IVD) equipment and reagents.
• Auditory and hearing aid devices.
• Infusion and injection devices.
• Endoscope.
• Surgical Implants.
• Laser devices.
• Medical software.

Medical device manufacturers who plan to launch their products in China, should actively consider these:

• From 2021, NMPA began to designate third-party laboratories with CMA laboratory accreditation to conduct medical device testing and issue compliance reports.
• NMPA began to implement the upgrade and transition of medical device product standards in 2020. The new version of GB9706.1:2020 has been mandatory since May 1, 2023 after a three-year transition period, and the full series of GB9706 standards will be implemented in phases before 2027. A large number of applicable standards need to be updated, revised and released; during this period manufacturers need to know which applicable standards to adopt for their products.
• NMPA registration certificates are valid for five years, whether it is the first registration, or subsequent changes involving product safety, or renewal after the expiration of the certificate, it is necessary to consider if the requirements of relevant standards are met.

Why partner with UL Solutions?

We have extensive laboratory resources and partnerships with several government laboratories in China to serve global medical device manufacturers, and help them confirm compliance to NMPA’s requirements.

We can provide a single source for your needs beyond testing to NMPA’s requirement, with a comprehensive suite of services including end-product testing, certification, validation (EMC, wireless, safety, interoperability, cybersecurity, biocompatibility), to help you streamline access to the China market.

Dedicated to healthcare industry innovation, we leverage decades of technical, regulatory and clinical expertise to help you manage regulatory challenges and bring safer products to market faster.

Our experts work closely with standards committees to stay up to date on all the new amendments and upcoming changes. These committees include the American National Standards Institute (ANSI), the Association for the Advancement of Medical Instrumentation (AAMI) and the International Electrotechnical Commission (IEC). UL Solutions has several US FDA ASCA-accredited testing laboratories globally.

To learn more, contact us.