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 […]
China has a new medical device classification catalog: what you need to know
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 […]
China’s FDA releases revised medical device classifications
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 […]
China wants to dominate medtech: Here’s how
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 […]
Tissuemed wins China’s OK for TissuePatch surgical sealant
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 […]
China investigates top medical device official
(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 […]
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.
FDA finalizes fast track for devices | Regulatory news for the week of April 13, 2015
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.
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.
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