TGA acts on promise to streamline special access – removing duplication of ethics committee review of clinical need and extending the duration of approvals. There’s also a new Special Access C – which sets up notification only pathways for medicines and devices with accepted history of use.
India continues toward implementation of the new Medical Device Regulations with publication of a new classification catalogue for 250 devices and IVDs.
Recent announcements from CFDA suggest that China is thinking again on the stringent requirements for manufacturers to conduct in-China clinical trials. The agency is accelerating the production of exemption lists and recent draft policy circulars open the door to acceptance of foreign clinical data and to post market trials of devices which address unmet clinical need. Is the pendulum starting to swing back?
On 17th May 2017, China FDA published a draft ‘Exemption List of Local Clinical Trial for Class II & Class III medical devices’. This is open for industry and user feedback with a deadline of 20th June 2017.
This will be the 3rd wave exemption list in China.
The new MDR is a long document, with interminable preambles and no quick way to get to the key Annexes.
So to help we have extracted the two key Annexes on Classification and Safety and Performance Requirements (Replacement for the Essential Requirements) into tow handy PDF documents.
The European Medical Device and Active Implantable Medical Device Directives have for more than 20 years provided the “best practice” regulatory model which has been adapted into so many other markets around the world. But now Europe has changed. How will other markets deal with the regulatory disconnect between the new European Model and the now outdated copies around the world? Is this new global disharmony a threat – or can others follow Europe’s lead and take the opportunity to deliver a more harmonised global regulation?