Pharma vs. Medical Device Regulations on the same Product

raghuramas · #1 16th July 2012, 06:15 AM

Dear All,

I am writing to Forum as I know i definitely get some answer from Forum members.

My product is MHRA licensed product and now there is a plan to clssify some of the products from Pharma to Medical Devices.

In this situation, do I need to get MHRA approval for the pharma product and CE marking approval from my Notifed Body for the medical devices. Please help.

Regards,
Raghu.

**Stijloor** · #2 18th July 2012, 04:04 AM

A Quick Bump!

Can someone help?

Thank you very much!!

**Ronen E** · #3 19th July 2012, 12:02 AM

Quote:

In Reply to Parent Post by raghuramas

now there is a plan to clssify some of the products from Pharma to Medical Devices.

Who is planning it? Can you provide more details about, or a reference to this plan?

What sort of products? What is the basis for reclassification?

	The Deming PDCA Cycle	ISO 9001 QMS Implementation	FMEA Information	APQP Information
Auditing Information	8-D Problem Solving	Statistics	Error Proofing (Poka Yoke)	Brainstorming
Identifying Waste	Pull Systems	Lead Time Reduction	Planned Maintenance	Quick Setup
Discovering Change	Process Capability - Cp vs. Cpk	Histogram Animation	Process Loop Animation	Taguchi Loss Function
		Fishbone / Cause and Effects Animation