In late August, China’s State Council released new guidelines designed to improve the registration and approval process for drugs and medical devices. The new guidelines will modify the drug registration process by accelerating the investigation and approval procedure for innovative drugs. Innovative... Read More
Since October 2014, when the Chinese Food and Drug Administration (CFDA) announced new regulations requiring medical device manufacturers to conduct more local clinical trials to obtain Class II and Class III approvals, the timeframe and cost to register products has grown exponentially.... Read More
The Chinese Food and Drug Administration (CFDA) has come under heavy criticism for its slow and inefficient drug review and approval process, which has resulted in a backlog of 18,600 applications. To improve drug review processing, the CFDA recently recommended that pharmaceutical... Read More
The number of clinical trials in India has dropped significantly over the last few years. Nevertheless, India’s Central Drug Standard Control Organization (CDSCO) has launched a system to allow online submission and monitoring of clinical trial applications. The system requires the input... Read More
The Chinese Food and Drug Administration (CFDA) has mandated that pharmaceutical companies with pending drug registrations must now self-audit their clinical trial data and submit their findings electronically to the CFDA by August 25, 2015. 1,622 drug registration applications, including 171 imported... Read More
This article was also published on the MassMEDIC blog. Background Getting medical devices registered and approved in China has become much more difficult with the October 2014 reforms. The cost is higher and the timeframe for registrations is a lot longer. Getting approval is... Read More
The China Food and Drug Administration (CFDA) issued guidelines (Chinese) for manufacturers seeking to register medical device software, including stand-alone and component software. The new guidelines list standardized technical review requirements for new registrations, as well as general guidance on items to... Read More
Singapore’s Health Sciences Authority (HSA) is finalizing guidance on medical devices classification for registration purposes. In July, the HSA issued two documents: GN-12-1: Guidance on Grouping of Medical Devices for Product Registration – General Grouping Criteria; and GN-12-2: Guidance on Grouping of Medical... Read More
Malaysia’s Medical Device Authority (MDA) has extended the deadline for expedited medical device registrations by one year to June 30, 2016. As reported in a previous news brief, device registration was originally slated to become mandatory in Malaysia as of July 1,... Read More
Last year, China released the “Procedure for Examination and Approval of Innovative Medical Devices (Trial)”, which went into effect on March 1, 2014. The Chinese Food and Drug Administration (CFDA) defined certain conditions that the applicant must fulfill in order to qualify... Read More