Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Policies
NMPA Draft Guideline Opens Door for Foreign Medical Device Makers to Use Overseas Labs for China Registration Self-Testing
NMPA published a draft document “Implementation Guideline for the Self-Testing Requirements of Medical Device Registration” for feedback. A particularly important clause is directly aimed at encouraging foreign participation—
“If a foreign registrant’s overseas parent group or its subsidiary owns a laboratory certified by a foreign government or by an internationally recognized laboratory accreditation body, and the laboratory is authorized by the parent group, the registrant may use that laboratory to conduct self-testing and issue the corresponding testing report.”
This clause allows overseas firms to leverage their in-house testing resources—such as labs already certified under ISO/IEC 17025 or accredited by regulatory agencies like the FDA or European Notified Bodies—to conduct regulatory testing for China submissions.
Click HERE for our comprehensive analysis
NMPA Classifies Non-Laser Light Source Device for Myopia and Amblyopia as Class II Device
NMPA released the Guideline for Classification of Medical Devices for Myopia Control and Amblyopia Treatment Involving Light Sources on July 16, 2025. The guideline offers regulatory clarity for market entry of ophthalmic devices that use light to manage myopia or treat amblyopia. It stipulates that, if the product uses red light from a non-laser light source (such as an LED light source) to irradiate the eyes for myopia control, it shall be regulated as a Class II medical device.
Click HERE for more information
Priority Approvals
NMPA Review Report Released for Inari Medical’s FlowTriever Retrieval/ Aspiration System
The NMPA granted innovation approvals to Inari Medical’s FlowTriever Retrieval/ Aspiration System and issued a review report.
This product is intended for catheter-directed thrombectomy treatment in patients with acute high-risk pulmonary embolism (PE) or intermediate-risk PE with clinical deterioration, under one of the following conditions:
- The presence of thrombus in the main pulmonary artery or major branches, with a high risk of bleeding or contraindications to thrombolytic therapy;
- The presence of thrombus in the main pulmonary artery or major branches, and the patient has failed thrombolysis or aggressive medical therapy.
The review report summarizes the product overview, pre-clinical, and clinical studies results. Click HERE for the full report.
About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com) provides turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent you for product life cycle without your need to create a local entity in China. Our RA services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and PMS. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.