| While the US market is large, the rest of the world is | | | | to the FDA (in Germany, for instance, it is called |
| also impacted by medical device recalls and drug | | | | BfArM, or Bundesinstitut fur Arzneimittel und |
| recalls. Whether it is a US supplier selling in Europe, or | | | | Medizinprodukte), and those bodies regulate products |
| an Israeli pharmaceutical company supplying Japan, | | | | being used in their areas. If adverse events or a |
| the process of medical device recalls and drug recalls | | | | product recall occurs within Germany, BfArM will |
| are similar in principle. | | | | collect that information and deal with the |
| Most every nation (or groups of nations) has their | | | | manufacturer. All of these bodies share information, |
| own specific medical device or pharmaceutical | | | | so a recall in Germany could trigger inquires from the |
| regulations, with appropriate governmental bodies to | | | | French version of the FDA, and frequently |
| regulate those markets. These bodies have | | | | manufacturers proactively inform all EU member |
| jurisdiction over domestic manufactures as well as | | | | states of a medical device recall or drug recall, even if |
| import/export activities by manufacturers or | | | | the recalled product was not present in a particular |
| distributors. | | | | EU nation. |
| Canada has a ministry known as Health Canada. | | | | So a US based manufacturer answers to the FDA, as |
| Korea has the Korean FDA (KFDA). Ireland has the | | | | well as each distinct regulatory body in any nation |
| Irish Medicines Board. Each of these nations have | | | | where their product is sold. In fact, in a case where a |
| their own requirements, which creates a burden for | | | | product is made in the US, and only sold outside the |
| manufacturers trying to send product to those | | | | US, the FDA will still be notified of any recall action |
| markets. In some cases, nations will accept the US | | | | and they will track that information just as if the |
| FDA as a recognized authority, essentially agreeing | | | | recall was a domestic issue. |
| that if it a product is safe in the US then it is safe | | | | Medical device litigation or drug litigation in those |
| for them. However, this is not the case in most | | | | nations will, of course, conform to local laws, and |
| places. | | | | manufacturers are bound to the laws and customs of |
| In the European Union (EU), there is a central law | | | | those markets. Simply being physically outside of the |
| called the Medical Device Directive honored by all | | | | borders of a country does not relieve one of |
| member states. Each nation has their own equivalent | | | | responsibility to conform to legal requirements. |