23/03/2016 10:16
In order to strengthen the management of medical device clinical trial, to protect the rights of the subjects, to standardize the trial operations and to obtain authentic, scientific, reliable and traceable clinical findings, the China Food and Drug Administration (CFDA) released...
15/05/2013 17:23
The General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China (AQSIQ), China Food and Drug Administration（CFDA）and Certification and Accreditation Administration of the People’s Republic of China (CNCA) jointly issued a public announcement about...
26/03/2013 21:51
CFDA is now a full ministry agency reporting directly to the State Council, which is China’s highest administrative body. It will integrate regulation and law enforcement in one agency.
Beside the change to a ministerial-level agency there are little changes in the way it regulates...
08/03/2013 16:11
The FDA has issued a final rule on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined...
13/02/2013 20:14
Food and Drug Administration Safety Innovation Act (FDASIA) requires the submission of electronic copies (eCopies) for most premarket submissions. An eCopy is defined as an exact duplicate of a paand per submission that is created and submitted on a compact disc (CD), digital video disc (DVD),...
08/10/2012 19:00
To intensify supervision on medical devices, ensure the safety of medical devices for the public, and in accordance with the Provisions for the Instructions, Labels and Packaging marks of Medical Devices (SFDA Order No. 10), the State Food and Drug Administration (SFDA) recently issued a notice,...
30/08/2012 20:54
Effective FY2013 (October 1, 2012) the requirements for medical device establishment registration and listing will change. Please see Medical Device Establishment Registration and Listing - Notice of Changes for FY 2013 for important information.
12/08/2012 17:37
The fees for fiscal year 2013 are as follows (small-business fees in parentheses):
PMAs:
$248,000 ($62,000)
Panel-track PMA supplements:
$186,000 ($46,500)
180-day...
05/08/2012 14:44
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