Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
NPMA (formerly CFDA) published the “Clinical Exemption Catalog for Medical Devices” yesterday (Sep 30th), in which a total of 855 medical devices and 393 IVDs exempted from clinical trial. It is the effort to implement risk-based clinical evaluation, and to make medical device clinical exemptions more consistent with internationally-accepted standard. To determine whether your device & IVD falls into the
The newly revised Medical Device Classification Catalog (hereinafter referred to as the “Classification Catalog”) released by China’s State Food and Drug Administration (CFDA) was officially released on August 31 this year but it won’t take into effect until August 1, 2018. The implementation of a new policy or regulation usually requires a period of transition so that relevant departments, units
The new “medical equipment classification directory” In recent years, the rapid development of China’s medical device industry, at present there are about 77,000 valid registration certificates of medical devices and more than 37,000 records of medical devices. With the continuous emergence of new technologies and new products, the current medical device classification system has been unable to fully meet the
On October 10th, the CFDA released a new notice about “The Related Work for Regulating the Medical Device Classification.” Here are the highlights: 1. For new medical devices that have not yet been listed in a “classification catalog” or medical devices that are waiting for classification notification by the CFDA, applicants should submit a classification application in CFDA classification system.
On October 31st, the CFDA released and implemented the 3rd batch of “Medical Device Clinical Trial Exemption List”. There are 37 Class II, 11 Class III medical devices and 116 Class II IVD included on this list. In the U.S., the medical device/IVD approval process is mature and well-developed, and 80% of medical devices/IVD can find referred predicate products and
Current Regulatory Process and Reform Companies interested in entering the Chinese market for innovative medical devices and treatments must first overcome existing barriers to market access and navigate an uncertain and changing regulatory environment. The “Management Standard for Technical Review and Consulting for Medical Devices,” (Management Standard) released in October 2016 has essentially closed the existing channel for pre-submission consultation
Here is the latest CFDA publication about Medical Device Classification Workflow For Overseas Companies: A. The application method Applicants can apply by visiting http://www.nifdc.org.cn/qxbgzx/CL0482/, clicking into the “medical device classification information system “, filling out the “classification application form” after registration, and uploading other application documents. Print the “classification application form” online and seal on the perforation of the form
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in February 2026. These updates are presented by China Med Device, LLC, your partner in Chinese market access. Policies NMPA Down-Classified Delivery Guide Devices and Certain Inner Ear Prostheses The NMPA issued the “Announcement on Adjustments to Certain Items in the Medical Device Classification
Here’s the latest China 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 China‘s New Draft of Medical Devices Biological Evaluation, in Full Alignment with ISO/FDIS 10993-1:2025 The NMPA National Institutes for Food and Drug Control released the draft GB/T 16886.1-2025, “Biological
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in September 2023. These updates are presented by China Med Device, LLC, your partner in Chinese market access. Policies RWD in China: Study Design and Statistical Analysis Guideline Propels Hainan to be World Leader NMPA published the “Guideline on Medical Device Real-world Study Design
The NMPA published the “Review Key Points for Artificial Intelligence Software for AI Magnetic Resonance Imaging Systems” on September 15, 2023. The guideline applies to MRI systems adopting AI technology, which is a Class III device according to “Medical Device Classification Catalog”. The AI software functions must run on the MRI system and be registered with the MRI system as
The NMPA published the “Review Key Points for Artificial Intelligence Software for AI Magnetic Resonance Imaging Systems” on September 15, 2023. The guideline applies to MRI systems adopting AI technology, which is a Class III device according to “Medical Device Classification Catalog”. The AI software functions must run on the MRI system and be registered with the MRI system as