RoHS (or similar) Requirements for Medical Devices in the World

max.polix

Involved In Discussions
#1
I wonder whether a summary of "RoHS like" requirements around the World is available, applicable to medical devices.

In Europe RoHS directive will be mandatory for MDs from July 2014.
I have heard Australia will apply equivalent rules.

What about USA-FDA, Brazil, China?

Thanks for any insight?

m.
 
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Michael Malis

Quite Involved in Discussions
#2
Implementation of restriction of the use of certain hazardous substances (such as RoHS, REACH, etc.) is already in-process for Medical Devices around the world.
The medical industry is dealing with a number of new substances that potentially carcinogenic or mutagenic, toxic or damaging reproductive or hormone system.
Under REACH, there are 53 substances identified that in the future, the industry will not be able to use or place in EU market.
Over the last 2 years, firms spend numerous time and money to:
• Identify where in the medical product substance is present.
• Identify the amount of substance usage in Tons.
• Register with EU to allow extended time for existing product use
• Identify candidates for product redesign in the future.

This is only the start of the process with more to follow!
 

max.polix

Involved In Discussions
#3
Thank you Michael.
However I think you have not answered to my question about the implementation of similar restrictions in not-EU countries.

Have you got any idea?

Thanks.
m.
 

Michael Malis

Quite Involved in Discussions
#4
Thank you Michael.
However I think you have not answered to my question about the implementation of similar restrictions in not-EU countries.

Have you got any idea?

Thanks.
m.
Similar restrictions has been proposed and evaluated by number of regions and countries around the world. Some (Australia) already adapted some of the restrictions, while others are still under evaluation.
One point is clear; - when it confirmed and verified that substance is bad, many already adapting plans for substitution and use of better materials.
In my opinion, this is the right approach because if you ban everything potential - like 53 products mention above, you will have no products to sell and that could be a greater risk to all who needs care as soon as possible.

I hope this helps,
Michael
 

max.polix

Involved In Discussions
#5
Michael,

I do agree with your approach.

Do you have a list of countries' regulations and dates for coming into force?

It might be helpful to make sure they do apply same requirements and to plan deadline-by-deadline withdrawal of devices in various countries, if they no longer meet the regulations.

Is RoHS the first to come into force?
What about China?
You say Australia adapted the same RoHS restrictions: is the 2014 deadline the same?

What I'm looking for is a summary, to get a clear picture that describes the World's Regulatory requirements on restriction of dangerous substances.

Thanks.
m.
 
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