Archive for August, 2009
FDA promises tighter enforcement action
In a 6 Aug press release FDA Commissioner Margaret Hamburg outlined how the FDA is implementing a five point strategy to improve their effectiveness system – http://bit.ly/3mEH0x
The plan involves setting post inspection deadlines, speeding up warning letters, the prioritization of enforcement issues and quicker action being taken against infringers. The agency will also introduce a formal warning letter close out process to make it clear when remedial action has been taken satisfactorily.
Updated clinical trials guidance document issued by MHRA
The MHRA has recently issued updated guidance on clinical investigations to be carried out in the UK. It’s an update on previously available guidance that takes into account the impact of 2007/47/EC, the revision to the directives which takes effect in March 2010. One of the major updates in this document is the confirmation that it will be much more difficult to obtain regulatory approval using only clinical literature and that more products will require a clinical investigation.
In addition the guidance talks the reader through making an application, outlines how it will be processed and what documentation will be required.Download here mhra-guidance-re-clinical-investigations-july-2009
For guidance as to whether your product will require a clinical investigation please contact Danielle.avadis@mediqol.com
India introduces proposals to regulate medical devices
The Indian Central Drugs Standard Control Organization (ICDSO) has recently published formal proposals outlining how it intends to regulate the medical devices sector. Currently medical devices are either regulated as drugs (if they fall in a list of ten product types) or not regulated.
The plans include the introduction of a risk based classification system with increased regulatory requirements and documentation being required for higher risk devices. The plans also suggest the involvement of Notified Bodies in the certification process and the introduction of a Indian equivalent of the CE mark.
If you’d like a copy of the 83 page document please drop us an email at enquiries@mediqol.com
