China has announced new and substantial fees for medical device submissions, with IMMEDIATE effect. Controversially, higher fees are charged to importers than to local manufacturers.
A Chinese saying “the one who tastes the crab first must be a brave person” is nowadays used to refer to the first person to tread a path unknown. Abbott Vascular must like seafood – as they are the first international manufacturer granted access to the new Innovative device registration pathway in China.
Revised renewal regulations take effect in China from 1 April. There’s a simpler streamlined process and automatic renewal of certificates held up in review. But be careful… conditions apply.
The introduction of Medical Device User fees in China has been anticipated since the introduction of new Medical Device regulation mid-2014. However, the amount proposed in the draft for comment fee table may raise a few eye brows. This level of CFDA fees will likely impact the current arrangements where distributors provide “Free” registrations for their suppliers as incentive – seeing there’s now real money at stake in getting a registration approved, even before the commercial ramifications of slow or failed submissions.
There has been a lot of discussion amongst the industry regarding the various transitional arrangements and new documentation requirements under China’s new medical device regulations. Since the introduction of the Class I Filing Pathway on 1 June and the implementation of the updated Class II/III medical device and IVD registration requirements on 1 October 2014, we have experienced some surprises (and also heard many stories) regarding the ways these regulations are enforced
For applicants with applications submitted under the old registration framework (particularly with review questions issued), a recent CFDA announcement has put a timeline to when the old framework will be terminated to give way to the revised Provisions for Medical Device Registration and Provision for IVD Reagent Registration. These new provisions have been effective since […]