7.2.1 c) of 13485 says that organization shall determine statutory and regulatory requirement related to the product.
Now this directly has a relevance to the country or region where the product is going to be put. In this global village and international trade scenario, most of the time manufacturers would not know which country the products would be going into when they build stock to forecasts.
Hence what are the ways by which a designer can get all inputs to make the product meet global market. Does anyone have a cross reference chart or a ready reconer / check list for all catagories of medical devices which once followed will meet the global statutory and regulatory requirement?
I have heard of national deviations and this one is real tricky. How many such deviations are there really ? What I am looking at is perhaps a collection of information to consider making a product in a catagory globally acceptable.
Any ideas or inputs from anyone across would go a long way ......... :agree:

7.2.1 c) of 13485 says that organization shall determine statutory and regulatory requirement related to the product...
...actually that statement is applicable when the product is in the development stage or simply in the process of making… and hence, the designer should consider all the applicable regulatory & statutory requirements where this product is going to be made or assembled… and the organization itself has to know what the regulatory & statutory requirements are… it is their responsibility to be familiar with these requirements and to comply with them…

…but once the product is finished, and the organization is about to export it to other countries, another regulatory laws (& requirements) are imminent – both to importing & exporting countries…

…national deviations vary as per area of jurisdictions…

…and if you are looking for compilations of information to consider when making a product in a global acceptable category, you are referring to the international standards that are widely acceptable and being recognized worldwide (e.g. international standards for manufacturing medical equipments)…

…but then again, you have to consider first the local regulatory & statutory requirements before going to international… since there are countries having different requirements not internationally recognizable or having different regulations than those from international standards… and you have to focus more on this aspect since you are going to produce first your product...

International Sales and Marketing need to be involved early in these discussions (often it is they that have generated the development project in the first place). They may well need to be educated on the regulatory process - it isn't the last phase of a development project, it goes on throughout (and indeed, afterwards).

Furthermore, where distribution chains are involved, there can be additional concerns to address.

or simply in the process of making… and hence, the designer should consider all the applicable regulatory & statutory requirements where this product is going to be made or assembled… SNIP…but then again, you have to consider first the local regulatory & statutory requirements before going to international… ISO 13485 requirements associated with product regulatory requirements are meant to make sure that the PRODUCT complies with the laws and regulations of the markets where it is going to be sold at.

If a product is assembled in Timboktuh, but intended to be sold in Jupiter, the laws of Jupiter for medical devices apply to the product.

While, it would be critical for the manufacturer to comply with labor, OH&S, environmental, etc. laws of Timboktuh, that falls outside of the scope of ISO 13485.

You have to identify the relevant statutory and regulatory requirements case by case and country by country.