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China Food & Drug Administration (CFDA)

Report: China to restructure its FDA

April 17, 2018 By Fink Densford

China is looking to restructure its Food and Drug Administration, according to a new report from the Regulatory Affairs Professionals Society. With the reorganization, the CFDA will cease being a standalone department and will become part of the country’s National Market Supervision Association, according to the report. The CFDA group is slated to add an […]

Filed Under: Regulatory/Compliance Tagged With: China Food & Drug Administration (CFDA)

China has a new medical device classification catalog: what you need to know

September 19, 2017 By MassDevice

Grace Fu Palma, China Med Device The China Food and Drug Administration (CFDA) recently unveiled its new “Medical Device Classification Catalogue” – which has significant implications for medical devices registrations or renewals. The new catalog, announced Aug. 31 after a previous draft release and feedback period, goes into effect in less than a year – on Aug. 1, 2018. Read the […]

Filed Under: Regulatory/Compliance Tagged With: China Food & Drug Administration (CFDA)

China’s FDA releases revised medical device classifications

September 8, 2017 By Fink Densford

Late last month, the Chinese Food and Drug Administration announced a number of changes to medical device classifications, revising criteria and categories and reducing the risk level of 40 different categories of products, according to China Med Device. In the update, the CFDA added more than 5,000 product name examples, bringing the total up to […]

Filed Under: Regulatory/Compliance Tagged With: China Food & Drug Administration (CFDA)

China wants to dominate medtech: Here’s how

September 1, 2017 By MassDevice staff

Under its “Made in China 2025” plan, the Chinese government seeks explosive growth in biomedical and high-end medical device manufacturing. Grace Fu Palma, China Med Device In 2015, the China State Council issued a 10-year manufacturing plan called “Made in China 2025.” The goal is to elevate the “giant but weak” Chinese manufacturing industry into […]

Filed Under: Business/Financial News, Emerging Markets, Regulatory/Compliance Tagged With: China, China Food & Drug Administration (CFDA), Made in China 2025

Tissuemed wins China’s OK for TissuePatch surgical sealant

June 1, 2016 By Brad Perriello

Tissuemed said it won approval from China’s FDA for its TissuePatch surgical sealant, claiming it as the 1st and only synthetic sealant approved in the People’s Republic. Leeds, England-based Tissuemed said the approval, which followed a 2½-year process, covers all surgical applications for the TissuePatch sealant film, beyond its usual uses in neurological and thoracic surgeries. “Approval […]

Filed Under: Regulatory/Compliance, Surgical Tagged With: China Food & Drug Administration (CFDA), Tissuemed

China investigates top medical device official

June 1, 2015 By Brad Perriello

(Reuters) — China launched an investigation into a top official who oversees the country’s medical devices sector, a disciplinary watchdog said, the 2nd healthcare official to be probed last week. A series of healthcare probes, part of President Xi Jinping’s crackdown on corruption, has thrown an unwelcome spotlight on executives, doctors and officials. Sources this […]

Filed Under: Regulatory/Compliance Tagged With: China Food & Drug Administration (CFDA)

China jacks up registration fees for medical devices, drugs

May 28, 2015 By MassDevice Contributors Network

China jacks up registration fees for medical devices, drugs

(Reuters) — The China Food & Drug Administration steeply raised the fees required to register medical devices and drugs in the world’s 2nd-biggest pharmaceutical market, as a lack of resources and expertise hinders its ability to process a rising number of applications.

Filed Under: News Well, Regulatory/Compliance Tagged With: China Food & Drug Administration (CFDA), Exports

FDA finalizes fast track for devices | Regulatory news for the week of April 13, 2015

April 14, 2015 By MassDevice Contributors Network Leave a Comment

FDA finalizes fast-track approval for medical devices

April 9, 2015 by Brad Perriello

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: CardiAQ Valve Technologies, China Food & Drug Administration (CFDA), Health Canada, HeartWare International Inc., HemCon Medical Technologies Inc., Hospira Inc.

HemCon enters Chinese wound care market

April 10, 2015 By Mark Hollmer

HemCon enters Chinese wound care market

HemCon Medical Technologies gained Chinese regulatory approval to start selling wound care products in the world’s largest nation.

Filed Under: News Well, Regulatory/Compliance, Wound Care Tagged With: China Food & Drug Administration (CFDA), Exports, HemCon Medical Technologies Inc., Wound Therapy

U.S. lawmaker seeks congressional hearing on ‘superbug’ outbreak

February 24, 2015 By MassDevice Contributors Network Leave a Comment

U.S. lawmaker seeks congressional hearing on 'superbug' outbreak

 

 (Reuters) – A U.S. lawmaker has called on the Congress to investigate the medical scopes blamed for an outbreak of a bacterial "superbug" at a University of California, Los Angeles hospital that has infected seven patients.

Filed Under: News Well Tagged With: Capitol Hill, China Food & Drug Administration (CFDA)

Allergan’s gains FDA approval for 2 new styles of breast implants | Regulatory news for the week of November 17, 2014

November 18, 2014 By MassDevice Contributors Network Leave a Comment

FDA approves 2 new Allergan breast implants

November 14, 2014 by Val Kennedy

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Allergan, China Food & Drug Administration (CFDA), Emergo Group, Medicrea

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