Tag Archives: China

CFDA and CMDE Issue Draft Guidance on Medical Devices for Rare Diseases

On February 6, 2018, the China Food and Drug Administration (CFDA) and its Center for Medical Device Evaluation (CMDE) issued a draft guidance entitled “Guidance on the Review of Medical Devices for Preventing and Treating Rare Diseases.” The draft guidance is based on the reform measures recently outlined in the government’s broad blueprint for drug … Continue Reading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

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

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 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

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

Spotlight on China: What Does the Chinese Government’s Investigation of the Pharmaceutical Industry Mean for the Device Industry?

In late June 2013, the Chinese government announced that it had detained four senior executives of GlaxoSmithKline for alleged economic crimes.  The Ministry of Public Security alleged that, since 2007, GSK transferred as much as $3 billion yuan ($489 million) to more than 700 travel agencies and consulting firms, some portion of which, the Ministry … 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

China Launches Review of Medical Device Industry

Two agencies in the Chinese government have initiated plans to review the levels of use and the pricing of medical devices marketed in China.  This news comes in the midst of several other investigations conducted by Chinese authorities into multinational corporations across a number of industries that are doing business in the country. This month, … Continue Reading

CFDA Publishes Draft Rule on Administrative Procedure for Public Comment

The Chinese government is currently taking steps to strengthen CFDA’s authority as an agency within the Chinese government, while at the same time increasing regulatory transparency.  As part of this effort, the China Food & Drug Administration (CFDA) recently issued a proposed rule (Draft Rule) to revise its 2002 Provisions on Legislative Procedures, which sets … Continue Reading

China Releases Device Sampling Inspection Regulations for Public Comment

Continuing with its efforts to strengthen medical device regulation, on July 19, 2013, the Chinese FDA (CFDA) issued draft Administrative Provisions on Quality Supervision Sampling Inspections for Medical Devices (Draft Provisions) for public comment.  The taking and testing of samples from companies or institutions that produce, circulate, or use medical devices is one of the … Continue Reading

Medical Devices Merger Suggests Global Antitrust/Competition Reviews Can Be Time-Consuming Even Without Direct Competitive Overlaps

Late in April 2013—following a many-month delay while approval from Chinese and Eastern European antitrust regulators was pending—two Japanese companies, Sony Corp. and Olympus Corp., announced that their medical devices merger had at last received final authorization. “Sony Olympus Medical Solutions Inc.,” as the new joint venture will be known, was officially established as of … Continue Reading

FCPA Enforcement Action Against China-Based Company and Lessons for the Device Industry

The first Foreign Corrupt Practices Act (“FCPA”) enforcement action of the year, which also appears to be the first FCPA-related enforcement action against a China-based company, underscores key areas that are likely to raise corruption issues in markets such as China.  This recent enforcement action also reinforces several lessons which are important for the medical … Continue Reading

CFDA Issues Proposed Regulations on Medical Devices

On March 20, 2013, the China Food and Drug Administration (CFDA) released for public comment two proposed regulations on medical devices.  The comment period for the proposed regulations ended on March 31, 2013. The first proposed regulation — titled Special Review and Approval Process for Innovative Medical Devices (Interim) (draft) — provides for special review … Continue Reading

China Reorganizes the State Food and Drug Administration and Appoints a New Commissioner

China’s 12th National People’s Congress has approved a plan to establish a ministry-level agency named China Food and Drug Administration (CFDA), which replaces the State Food and Drug Administration (SFDA).  The agency has started a reorganization under the leadership of a new commissioner, Mr. Zhang Yong. On March 22, 2013, SFDA replaced the sign on … Continue Reading