Archives: Device Regulation in China

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CFDA Issues Groundbreaking Proposals for Medical Device Regulatory Reform

Last month, the China Food and Drug Administration (CFDA) published drafts of four proposed policies in the form of circulars (or notices) for public comment. These proposed policies include significant reforms in the areas of the new drug and device approval process (“Circular 52”), clinical trial regulation (“Circular 53”), life-cycle management and post-marketing surveillance (“Circular … Continue Reading

CFDA Releases Draft Classification Catalogue of Medical Devices

The China Food and Drug Administration (CFDA) has recently released a long-anticipated draft Classification Catalogue of Medical Devices (Draft Catalogue). The Draft Catalogue updates a 2002 Classification Catalogue (Current Catalogue) and is one of the final pieces in the reform of China’s medical device system that has taken place since the 2014 revision of the … Continue Reading

CMDE Releases New Inquiry Rules on Medical Device Technical Review

On October 20, 2016, the Center for Medical Device Evaluation of China Food and Drug Administration (CMDE) released Guidance for the Management of Inquiry on Medical Device Technical Review (“New Guidance”).  The New Guidance replaces CMDE’s Guidance for the Management of Technical Inquiry on Registration of Medical Device (effective as of March 26, 2007, the “Prior … Continue Reading

CFDA Releases New Administrative Measures on Medical Device Recalls for Comment

The China Food and Drug Administration (CFDA) is expanding its reach over device recalls. In early September, CFDA released a long-awaited draft of the Administrative Measures on Medical Device Recalls (Proposed Rules).  These significantly-expanded measures would replace the current medical device recall rules that the Ministry of Health (now the National  Health and Family Planning … Continue Reading

CFDA Proposes Priority Review Pathway for Certain “Breakthrough” Medical Devices

The China Food and Drug Administration (CFDA) recently released draft rules proposing a new priority review pathway of premarket submissions for certain medical devices with breakthrough technologies (Proposed Rules).  This priority pathway builds upon the State Council’s Opinion on Reform of the Drug and Medical Device Approval System (“Document No. 44”), which was released in … Continue Reading

CFDA Releases New Self-Assessment Reporting Requirements for Medical Device Distributors

On June 7, 2016, the China Food and Drug Administration (“CFDA”) released the Notice on Regulating Distribution Activities in Medical Device Circulation (“Notice”). The Notice requires that distributors of Class II and III devices assess their compliance with Medical Device Good Supply Practices (“GSPs”) and other medical device regulations over the course of the last … Continue Reading

CFDA Releases New Device Clinical Trial Exemption Catalogues for Comment

On May 20, 2016, the China Food and Drug Administration (“CFDA”) published drafts of two medical device clinical trial exemption catalogues on Class II and Class III devices for public comment (“CFDA Draft Catalogues”).  Comments are due on June 20, 2016.  This is the second round of clinical trial exemption catalogues since the revisions to … Continue Reading

China’s New Medical Device Good Clinical Practices to Go Into Effect June 1, 2016

The China Food and Drug Administration (“CFDA”) and National Health and Family Planning Commission of China (“NHFPC”) have jointly released a revised and substantially expanded set of Good Clinical Practices for Medical Device Clinical Trials (“New Device GCP”), which will go into effect on June 1, 2016.  The New Device GCP are an important piece … Continue Reading

CFDA Restructures Medical Device Adverse Event Regulations

Following a significant revision of its framework medical device regulation (see our alert, here), the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission (“NHFPC”) have released a proposed revision to the Administrative Measures on Monitoring Medical Device Adverse Events and Re-Evaluation (“proposed Measures”), which is the primary regulation for … Continue Reading

Upcoming Webinar: Regulation of eHealth Products and Mobile Apps (February 25, 2015)

As part of Covington’s ongoing Life Sciences Essentials webinar series, we will be presenting a program on Regulation of eHealth Products and Mobile Apps on February 25, 2015 (12:30-2:00 p.m. EST). Our panelists, including two alumni of the FDA Office of Chief Counsel, will address: What factors determine whether an eHealth product is considered a medical device … Continue Reading

CFDA Proposes New Regulations on the Accreditation of Medical Device Trial Sites

On December 15, 2014, the China Food and Drug Administration released proposed Measures for the Accreditation of Medical Device Clinical Trial Institutions (Measures) for public comment. The comments are due on February 28, 2015. The Measures articulate the process by which medical institutions in China can apply to the government to become accredited to conduct … Continue Reading

China Issues Multiple Final Rules and Proposals to Implement Recent Revisions to its Core Medical Device Regulation

Throughout August 2014, the China Food and Drug Administration (CFDA or the Agency) made significant process in issuing finalized rules and guidances to implement the revisions to its core medical device regulation, the Medical Device Supervision and Administration Regulation (MDR) (see our alert, here).  The State Council revised the MDR in March, and it went … Continue Reading

China Releases New Notification Procedures for Class I Medical Devices

The China Food and Drug Administration (CFDA) issued a Notice on Items Related to Class I Medical Device Notifications (Notice) to establish new notification procedures for Class I medical devices, which includes in vitro diagnostics.  This Notice is one of several that CFDA issued at the end of May 2014 related to the implementation of … Continue Reading

CFDA Clarifies Implementation Issues for New Medical Device Regulation

On June 1, 2014, the newly revised Medical Device Supervision and Administration Regulations (revised MDR) took effect.  The revised MDR has changed medical device regulation in China significantly (described here), but some of the revised provisions conflict with implementing rules for the prior MDR that are still legally effective.  Although the China Food and Drug … Continue Reading

China’s Legislative Affairs Office of the State Council Extends Comment Period for Proposed Rules Implementing the Revised Medical Device Regulation

Recently, the China Food and Drug Administration (CFDA) extended the comment period for five key rules implementing China’s revised medical device regulatory system.  Device companies and other stakeholders now may comment on these rules until May 31, 2014.… Continue Reading

CFDA Announces “Five Rectifications Campaign” Targeting Medical Devices

On March 13, 2014, the China Food and Drug Administration (CFDA) announced the Five Rectifications Campaign, a special five-month enforcement campaign targeting medical devices. The Campaign will focus on medical device registration, manufacturing, distribution, advertising, and use in healthcare institutions.  The campaign began on March 15, 2014 and will end on August 15, 2014.… Continue Reading

China Issues Special Procedures for Innovative Medical Devices

In February 2014, the China Food and Drug Administration released Trial Procedures for the Special Examination of Innovative Medical Devices (Special Procedures).  CFDA released a draft of the Special Procedures for public comment in mid-2013, described here.  Under these special procedures, if a medical device meets certain criteria it will be eligible for “priority” evaluation … Continue Reading

CFDA Issues Guide for Routine Inspections of Medical Device Manufacturers

On January 13, 2014, the China Food and Drug Administration (CFDA) issued a Guide for Regular Site Inspections of Medical Device Manufacturers.  The Guide is to be used by local authorities and inspectors during a site inspection of device manufacturing facilities.  It includes detailed guidelines as to all facets of the inspection, including the credentials … Continue Reading

CFDA Reduces Application Requirements for Medical Device License Amendment and Renewal Processes

The China FDA (CFDA) released a Notice on Matters Related to Medical Device Re-registration on December 9, 2013.  The Notice reduces burdensome requirements in the application process for domestic and foreign manufacturers when renewing or making changes to an existing medical device license in China.  It does not apply to registration of in vitro diagnostic … Continue Reading

China FDA Seeks to Improve Medical Device Evaluation at the Provincial and Municipal Government Levels

On October 23, 2013, the China Food and Drug Administration (CFDA) released a Guiding Opinion entitled “Increasing the Capacity of Provinces to Conduct Medical Device Evaluations (Guiding Opinion).”  This Guiding Opinion is part of a larger effort to improve provincial- and municipal-level management of medical device approval and postmarket surveillance.  The Guiding Opinion does not … Continue Reading

CFDA Releases Plan to Improve Medical Device Adverse Event Monitoring

On October 8, 2013, the China Food and Drug Administration (CFDA) released a key guidance document advancing its system for monitoring medical device adverse events.  The document or “Guiding Opinion” sets forth a two-year plan (2013-2015) for increasing the capacity of local governments to gather information on adverse events, evaluate them, manage the release of … Continue Reading

Drug and Device Investigations in China May Drive Reform of the Medical Profession

Underlying many of the investigations of the drug and device industries in China are complaints about corruption in the medical profession.  These complaints could spark a legislative change in the future. Recent news reports and commentary are very consistent in describing the issue.  The majority of hospitals in China are government-owned, and the majority of … Continue Reading
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