CE technical file - Buying Surgical Mask from China

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J

jrubio

#12
You were right

You were right. :applause:

I did not know that exist a EN Quality System??

EN ISO 13485:2003

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)


As you stated are difference world...

:applause:

Thank you
 
J

jrubio

#13
The Harmonised Standards is the easy way

The Harmonised Standards is the easy way to ensure that the directives are met, but it is voluntary to follow them.

This is a prescription in Industry Arena.

Is this stement still valid for medical devices?.

Can a enterprise has a Quality System such as ISO 9001 and ensure that they meet the Directive?.

I think so.

Well your comments will be much apreciated.

Remarks.
 

Al Rosen

Staff member
Super Moderator
#14
It is possible to show conformity other ways, but I think most Notified Bodies will want ISO 13485.

For class I, non sterile, non measurement, devices you don't need a Notified Body. It can be done through self certification. This, in fact, may be all that is required for this surgical mask.
 
J

jrubio

#15
surgical mask must be sterile,

Al Rosen said:
It is possible to show conformity other ways, but I think most Notified Bodies will want ISO 13485.

For class I, non sterile, non measurement, devices you don't need a Notified Body. It can be done through self certification. This, in fact, may be all that is required for this surgical mask.

But all the surgical mask must be sterile, therefore it needs thierd body.
 
J

jrubio

#16
sterile condition

Annex IV, V or Vi. Application of the abovementioned Annexes and the intervention by the notified body is limited to:
- in the cast of products placed on the market in sterile condition, only the aspects of manufacture concerned with securing and maintaining sterile conditions,
 
#17
Dear All!!
I am owner of small distribution company in Poland.

I would like to buy from China surgical mask.

As it is medical device class1 under mdd93/42 in my opinion manufacturer has to have min. ISO9001 plus CE tech file.

They do have ISO., but I need to make a CE tech file .

Maybe somebody have some drafts in word or similiar.

Maybe somebody could also advice on some surgical gowns designs, sheets etc.

I am also open for all business proposal if you are a manufacturer of MD with CE certificate.

Best Regards

Piotr (Peter)

Dear Piotr

I have surgical mask and other products, like FFP2 available in Netherlands, including CE conformity. No worry to import from China. Easy delivery within EU, from Netherlands , delivery in few days

2MEDICAL-europe BV Netherlands [email protected]
 
#18
Dear All!!
I am owner of small distribution company in Poland.

I would like to buy from China surgical mask.

As it is medical device class1 under mdd93/42 in my opinion manufacturer has to have min. ISO9001 plus CE tech file.

They do have ISO., but I need to make a CE tech file .

Maybe somebody have some drafts in word or similiar.

Maybe somebody could also advice on some surgical gowns designs, sheets etc.

I am also open for all business proposal if you are a manufacturer of MD with CE certificate.

Best Regards

Piotr (Peter)


contact us at infoatmoxientdotcodotuk
 
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