Q&A – China NMPA Classification
Frequently Asked Questions about China NMPA Registration for medical devices and IVDs:
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Register for Upcoming Webinar on DEC. 8 @ 11AM
2025 China NMPA Bluebook is here:
Frequently Asked Questions about China NMPA Registration for medical devices and IVDs:
NMPA issued the “Artificial Intelligence Medical Software Classification Guideline” on July 8, 2021, to direct manufacturers for the classification and the corresponding clinical data and regulatory submission. It is the finalized version of the draft released on May 3, 2021. Please click HERE for our technical review on AI-aided Software Guideline. The article was published on BioWorld, a Hong Kong-based
Unique Device Identification (UDI) will be implemented with all Class III devices, announced by NMPA at the “Notice on Applying Unique Device Identification System for the Second Group of Devices (draft for feedback)” on May 31, 2021. The proposed effective date of January 1, 2022. Feedbacks need to be submitted by June 15, 2021. 69 high-risk class III device were
The NMPA released the Annual Report for Medical Device Registration on February 5, 2021. In 2020, the NMPA accepted a total of 10,579 medical device initial registrations, registration renewals and registration changes, in which imported devices account for 61.1% of the total number. Despite the impact of the pandemic, the total number of acceptance increased by 15.6% compared with 2019.
The NMPA released the Revised Catalog of Medical Devices and IVD Products Exempted from Clinical Trials on January 19, 2021. It is an effort to implement risk-based clinical evaluations, and to make medical device clinical exemptions more consistent with internationally accepted standards, the NMPA stated in the notice. Ask us if your devices or IVDs are in the Catalog. Even
Overview of Medical Device Classification in China Compared with the previous catalog system, the key changes are: The number of device categories have decreased from 43 to 22. 1,157 subcategories have been added. Product description and intended use have been added to determine the right classification. Furthermore, the difference between the sterilized device and the non-sterilized device, under the same
The NMPA released the updated Medical Device Classification Catalog on December 31, 2020, providing modification on management category and device classification. Classification Catalog 2020 Complete List: 15 medical devices are down-classified, including seven class III and eight class II. Previously Class III, Now Class II: Active equipment for endoscopic surgery Urinary X-ray machine Oral X-ray machine Optical endoscope Electronic endoscope
NMPA announced the Procedure of Dynamic Amendment of Medical Device Classification Catalogue (Draft) on November 13, 2020, providing a more risk-based and internationally recognized pathway for medical device classification. Feedbacks need to be submitted by December 15, 2020. Procedure for Modification This draft document proposes the procedure as follows: Overseas manufacturers submit “Classification Catalogue” suggestions to the Center for Medical
A focused ultrasound stimulator, designed for cosmetic procedures, is the first aesthetic device to benefit from the Hainan policy to allow the use of unapproved but urgently-needed medical devices. On January 5, 2020, Hainan Boao Super Hospital began the clinical use of The Ulthera System, an FDA-cleared, non-invasive procedure that lifts and tightens the skin on the neck, chin and
China’s current NMPA medical device classification system has been in place since August 1, 2018, which specifies that “classifications should be based on the Device Category, Subcategory, Example of Device Names, Product Description and Intended Use.” Compared with the previous catalog system, the key changes are: The number of device categories have decreased from 43 to 22. 1,157 subcategories have
NMPA (CFDA) published the First Batch of Medical Device Classification Results on July 18. This document, classifying Class III (56 items), Class II (78 items), Class I (53 items) and Non-Medical Devices (5 items), serves as a guide to manufacturers for ambiguous device classifications. Some cosmetic devices are classified as medical equipment for the first time. Previously cataloged as Non-Medical
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