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China Medical Devices CFDA

Morgan Lewis

CFDA Issues New Classification Catalogue for Medical Devices In China

Morgan Lewis on

The new catalogue, which becomes effective on August 1, 2018, is likely to have a significant impact on the registration, manufacturing, operation, and distribution of medical devices in China. ...more

Hogan Lovells

Major IP reforms foreshadowed in China’s Pharma sector

Hogan Lovells on

On 12 May 2017, the Chinese Food and Drug Administration (the “CFDA”) issued several draft policies aimed at overhauling of the current regulations governing the Chinese pharma and medical device sector (the “Draft...more

A&O Shearman

CFDA’s New Draft Policy Introduces the Chinese Version of Patent Linkage

A&O Shearman on

On May 12, Chinese Food and Drug Administration (CFDA) issued Policy Notice No. 55, entitled “Policies Relevant to the Protection of the Rights and Interests of Innovators for the Encouragement of Innovation in Drugs and...more

Cooley LLP

Alert: China Food and Drug Administration Offers Guidance on Clinical Trial Exemptions for Medical Devices

Cooley LLP on

The "Administrative Measures for the Registration of Medical Device" (Registration Measures) was issued by the China Food and Drug Administration (CFDA) and became effective on October 1, 2014. According to the Registration...more

Cooley LLP

Alert: China Piloting Drug Marketing Authorization Holder System

Cooley LLP on

The Chinese central government has taken several important steps in reforming the drug approval system in China, which could have far-reaching implications for pharmaceutical companies in China as well as foreign companies...more

McDermott Will & Emery

China Solicits Comments on Good Supply Practices for Medical Devices

McDermott Will & Emery on

The China Food and Drug Administration recently published a draft regulation setting minimum standards for medical device distribution. The regulation sets forth requirements for procurement, delivery acceptance, storage,...more

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