Blog

January 17, 2018

CFDA Issued Guideline for Clinical Evaluation of Proton/Carbon Ion Therapy System

This guideline is to inform the applicants on the Clinical Evaluation of Proton and Carbon Ion Therapy System. This document does not fully cover the clinical evaluation data that may […]
January 17, 2018

China’s National Strategy for Filling These 5 “High-End” Medical Device Categories

On December 26th, 2017, the ‘Notice on Enforcing the Three-year Action Plan for Strengthening Core Competitiveness in Manufacturing Industry (2018-2020) and Implementation Plan for Industrialization of Key Technologies in Key […]
January 15, 2018

CFDA Published Drug And Medical Device Overseas Inspection Regulations

As part of an effort to standardize the overseas inspection of drug and medical device manufacturing and ensure the quality of imported products, the CFDA just published the Draft for Comments […]
January 12, 2018

Big Data Tells You: Why is there an enormous prospect of the big health industry?

What is Big Health? Big health includes health service, pharmaceuticals, medical device, wearable health device, physical therapy, beauty, dietary supplements, healthy diet, sports and recreation, health examination, health maintenance, healthy […]
January 12, 2018

Opportunities for 3D printing medical device application in China

CFDA approves first four 3D printed human body implants In September 2015, the first 3D printed human body implant – the artificial hip joint was approved in China by the […]
January 11, 2018

China’s “Three-Year Action Plan for Enhancing the Core Competence of Medical Device Manufacturing Industry (2018 – 2020)”

  Recently, in order to speed up the development of advanced manufacturing industries, promote the deep integration of the Internet, big data, artificial intelligence and real economy, and break through […]
January 11, 2018

Key Takeaways from CFDA’s “Medical Devices Online Sales Supervision and Management Measures”

As planned, CFDA is to enforce its “Medical Devices Online Sales Supervision and Management Measures” on March 1st, 2018 that governs online sales of all medical devices in China.   […]
January 10, 2018

CFDA Issued Registration Technical Review Guidelines for Mobile Medical Devices

1. Scope This guideline applies to the application registration of class II and III mobile medical devices. 2. Mobile Medical Device (1) Definition of Mobile Medical Device A “mobile medical […]
January 8, 2018

Take Advantage of CFDA’s Priority Channel For Your Medical Device

As part of CFDA’s implementation of reforms to its approval systems for drugs and devices and to meet the clinical demands of medical devices, CFDA opened up its priority review […]
January 5, 2018
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FDANews Webinar on Jan 17: How to Get IVD Approval Through CFDA

Learn Key CFDA Premarket Submission Tips for IVD Approval Register here for the webinar Wednesday, Jan. 17, 2018 · 1:30 p.m. – 3:00 p.m. EST Marketing medical devices and IVD […]
January 4, 2018

China’s Grand Pharmaceutical and Canada’s Conavi Medical Align On Imaging Technology

China’s Grand  Pharmaceutical has announced that it entered into a subscription agreement with Canada’s Conavi Medical. The two companies also entered an exclusive distribution agreement for Conavi’s products. Pursuant to […]
January 3, 2018

New CFDA Guidelines on 12 Categories of Medical Devices

The CFDA issued 12 new guidelines on December 22nd, 2017. While they are titled guidelines, once they are officially released, you are expected to comply with them whether your products are […]