Spring has come for the genetic sequencing industry. Manufacturers and service providers previously devastated by the CFDA announcement on the prohibition of clinical testing for genetic sequencing in February 2014 can now take courage in the recent approval of a second generation sequencers from BGI (Shenzhen, China).
Archives for July 2014
Following extensive industry dialogue, TGA extended to 2015 the timeframe for transition to the regulatory framework for commercial IVDs, and later for in house IVDs. However there are some important exclusions – especially for currently uncertified, unregistered, Commercial Class IV IVDs, where urgent action is required to avoid a prohibition from sale.
TFDA has budgeted 1.2 million NTD (About AUD$42.5k) for investigation of how the developing and assessment of high tech medical device is regulated in US and Europe, as a reference for developing their own.
The CFDA has published 14 technical guidance aimed at helping its technical reviewers and the industry to understand the key criteria for evaluating the safety and effectiveness of relevant products. Though conformance to these are not mandated by law, such technical guidance are extremely helpful.
It has been a long standing policy of the Chinese government to encourage the development of domestic medical device manufacturers. However, the local ministry of health in Xuzhou, eastern China, has been more active than most in specifically decreeing a dozen or so hospitals that for their planned medical equipment procurement, they were to acquire domestic CT or MRI equipment only. The official announcement also named a few domestic manufacturers for consideration.