News & Analysis as of

CFDA

CFDA Issues New Classification Catalogue for Medical Devices In China

by 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

China FDA Updates the Medical Device Classification Catalogue

by Ropes & Gray LLP on

On August 31, 2017, the China Food and Drug Administration (“CFDA”) announced the final revision to the 2002 Medical Device Classification Catalogue (“2002 Catalogue”). The revised version (“New Catalogue”), which will become...more

Major IP reforms foreshadowed in China’s Pharma sector

by 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

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

by Allen & Overy LLP 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

CFDA Amends Medical Device Recall Rules

by Ropes & Gray LLP on

Recently China’s Food and Drug Administration (“CFDA”) released the Provisions for Medical Device Recall (“New Recall Rules”). The New Recall Rules, becoming effective on May 1, 2017, will replace the existing Interim...more

China FDA Announces Good Clinical Practices for Medical Devices

by Ropes & Gray LLP on

On March 23, 2016, the China Food and Drug Administration (“CFDA”) and the National Health and Family Planning Commission jointly promulgated the final revision to the 2004 Medical Device Clinical Studies Rules (“MDCSR”), the...more

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

by 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

Alert: China Piloting Drug Marketing Authorization Holder System

by 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

China FDA Solicits Comments on Resolving the Backlog of Drug Applications

by Ropes & Gray LLP on

The China Food and Drug Administration (“CFDA”) recently published a draft circular to address the backlog of drug applications. The Circular Regarding Several Draft Policy Opinions to Accelerate the Resolution of the Backlog...more

China FDA Releases Guideline for Medical Device Registration Studies

by Ropes & Gray LLP on

On May 19, 2015, the China Food and Drug Administration (“CFDA”) unveiled the Technical Guideline Governing Medical Device Clinical Evaluation (“Guideline”). The long-awaited Guideline explains the methodology for clinical...more

China Announces Revised Good Clinical Practices for Public Comments

by Ropes & Gray LLP on

The China Food and Drug Administration (“CFDA”) recently released its proposed revisions to Good Clinical Practices (“GCP”) for pharmaceutical clinical studies for public comments. The proposed revisions, if eventually...more

China Introduces New Medical Device GMP and GSP Rules

by Ropes & Gray LLP on

In December 2014, China’s Food and Drug Administration (“CFDA”) revised the existing provisional Good Manufacturing Practices for medical devices (“New GMP”), and issued the country’s first Good Supply Practices for medical...more

China Solicits Comments on Biosimilars Guideline

by Ropes & Gray LLP on

The Center for Drug Evaluation (“the CDE”) of the China Food and Drug Administration (“CFDA”) recently published a long-awaited guidance document for companies seeking to develop biosimilars. This document, titled Draft...more

China Unveils Detailed Rules to Implement the Core Device Regulation

by Ropes & Gray LLP on

The amended Regulation for the Supervision and Administration of Medical Devices (the “Regulation,” also known as the State Council Order No. 650), which came into force on June 1, 2014, set the new framework for China’s...more

Significant Revisions to China’s Regulations on the Supervision and Administration of Medical Devices (State Council Order No....

by Reed Smith on

China’s State Council released its new Administrative Regulation on the Supervision and Administration of Medical Devices March 7, 2014, which will be effective June 1, 2014 (the “New Regulation”). The State Council...more

China Introduces Major Changes to Medical Device Regulations

by Ropes & Gray LLP on

On March 31, 2014, China’s State Council released the amended Regulations on the Supervision and Administration of Medical Devices (the “Regulations”), effective as of June 1, 2014. A series of implementing rules are expected...more

China Tightens Supervision and Enforcement in the Medical Device Sector

by Ropes & Gray LLP on

On March 13, 2014, the China Food and Drug Administration (the “CFDA”) announced an action plan titled “Rectifications of Five Common Types of Noncompliance Concerning Medical Devices” (the “Five Rectifications Campaign”). A...more

China Solicits Comments on Good Supply Practices for Medical Devices

by 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

China Releases Fast Track Approval Process for Innovative Medical Devices

by Ropes & Gray LLP on

On February 7, 2014, the China Food and Drug Administration (“CFDA”) promulgated a notice titled The Fast Track Approval Process for Innovative Medical Device (Tentative), effective as of March 1, 2014. Unlike the draft...more

China Issues New Regulations Prohibiting Commercial Bribery in the Health Care Industry

by Reed Smith on

In late December, China’s National Health and Family Planning Commission ("NHFPC"), the successor organization to the Ministry of Health, issued two sets of anti-corruption regulations for the health care industry: the 2013...more

China Expects Major Changes in Drug Registration and Contract Manufacturing Rules

by Ropes & Gray LLP on

The China Food and Drug Administration (“CFDA”) recently announced several draft rules, most notably, the Draft Amendment of the Provisions for Drug Registration (also known as the Drug Registration Rules, DRR) and the Draft...more

China Releases Vaccine Good Clinical Practices

by Ropes & Gray LLP on

On October 31, 2013, The China Food and Drug Administration (“CFDA”) promulgated a regulation titled Guiding Principles for the Quality Management of Clinical Studies on Vaccines (“Vaccine GCP”), with immediate effect. The...more

China Tightens Food Safety Administration

by Ropes & Gray LLP on

The Chinese State Council recently announced the draft amendment of the Food Safety Law (“Draft Amendment”) for public comments through November 29, 2013. A high priority initiative on the Chinese government’s agenda to...more

China Solicits Comments on Post-Market Study Guidelines

by Ropes & Gray LLP on

The Center for Drug Evaluation (“CDE”) in China recently published the draft Guidelines for the Administration of Post-Market Studies on Chemical Drugs and Therapeutic Biologics (“Draft Guidelines”) for public comments...more

China Solicits Comments on New Drug Technical Review Guidelines

by Ropes & Gray LLP on

The Center of Drug Evaluation (“CDE”) of the China Food and Drug Administration (“CFDA”) recently announced the Draft Guidelines for Clinical Evaluation of NDA/BLA Applications (“Draft Technical Review Guidelines”) for public...more

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