Complying ISO 13485 - Require other documentation specified by regional regulations?

Hi experts..
I've a bit confusing here. If a medical device manufacturer have complies all ISO 13485:2003 requirements, is the company still need to comply with other regulations such as from US FDA QSR or EC in order to place the devices internationally?

In ISO 13485 documentation requirements, clause 4.2.1 (f) listed that the standard require "any other documentation specified by national or regional regulations". What types of that documents actually? Is it mean that by only complying requirements stated in ISO 13485 standard is not enough to export the devices to other country such as US or Europe?

As example, is manufacturers in Malaysia need to documenting Medical Device Incident/Accident Procedure which required by FDA, or 'report of incident' which is needed by MDD eside from CE Mark?

I hope anyone can help and i'm very appreciate it.
Thanks so much for any information.

Re: Complying ISO 13485 - Require other documentation specified by regional regulatio

You have to comply with all regulations to the country or jurisdiction that you are selling to.

FDA requirements for the US, CE marking for Europe, CMDCAS for Canada, PAL for Japan, and others.

Each country or jurisdiction have their own requirements which must be satisfied.

Danny

Re: Complying ISO 13485 - Require other documentation specified by regional regulatio

Yes, complying to ISO 13485 is not enough to export the devices to other countries such as US or Europe. For exemple, in the case of Europe you have to comply with the MDD to get the CE mark, the CE mark is obrigatory for equipment to be sold in Europe.

Re: Complying ISO 13485 - Require other documentation specified by regional regulatio

Apalah konsultant ini? In near future when the Malaysian Medical Device Act comes into enforcement under the MOH, the organization not only have to fulfil to ISO 13485 but also the device registration with MOH and mandatory reporting with MOH.

After all, ISO 13485 is spelt twith for regulatory purposes. So the organization has to fulfil the applicable regulatory requirements. However some may not required to fulfil the product type approval but to ensure the safe and effectiveness of the product. For example. MDD CLass I (other than sterile and measuring function) do not required product type testing or approval but teh organziation has to fulfil the applicable ISO 13485 and regulatory requiremenst lah...abang ohhh..

Re: Complying ISO 13485 - Require other documentation specified by regional regulatio

Thanx a lot for the info replied by Danny K, mmantunes, and SilverHalk..

ISO 13485:2003 is an international standard for quality management system. Medical device manufacturers need to comply with this standard to demonstrate their ability to provide medical device and related services that consistently meet customer requirements and regulatory requiements.

This standard is for quality management system, but not for quality and safety for specific product. So that medical device manufacturers still need to comply with regulatory requirements such as FDA and CE mark in order to conform safety and effectiveness of the products..Am i right..?

Re: Complying ISO 13485 - Require other documentation specified by regional regulatio

You´re almost right!

This International Standard specifies requirements for a quality management system that can be used by an
organization for the design and development, production, installation and servicing of medical devices, and
the design, development, and provision of related services.

Click to expand...

a) communicating to the organization the importance of meeting customer as well as statutory and
regulatory requirements,

NOTE For the purposes of this International Standard, statutory requirements are limited to the safety and
performance of the medical device only.

Click to expand...

Thus, the quality management system of ISO 13485 is used to demonstrate the ability to manufacture ANY medical device, and in this way it´s product specific. Also, safety and performance are not really a regulatory requirement, altough they are enforced by it. They should be a integral part of the equipment, and not be there because some regulations asks for it.