One of the major issues regarding the U.S. market and distribution of medical products is the regulation and oversight of medical products coming into the U.S. from abroad. Other countries, especially the less developed nations, have different regulations regarding the production and distribution of medical products, and sometimes these regulations don’t quite meet the standards of U.S. health standards. Most products are produced in the United States, but since some companies will manufacture their products abroad as a cost saving measure, the Food and Drug Administration (FDA) has taken several steps to assure the American public that the medical products that are being manufactured abroad still have the assurance of reliability, effectiveness, and safety that the U.S. manufacturers must provide.

There are a couple foreign countries with strongly improving economies who are greatly increasing their trade with the United States, some of which include Mexico, India, Brazil, China and South Africa, and therefore due to the heavy export of medical devices from these countries, new and stronger regulations from the FDA must be made to asses and inspect these products, especially since these economically emerging countries have less strict medical device manufacturing regulations.

Here are a couple more things that you need to know about medical products and the FDA’s mission to keep foreign-made medical devices and products at the same standard as U.S. made products.

– The FDA has increased their oversight of imported medical devices and products by 13% in the last 10 years, which also means that the amount of products and medical devices produced outside of the U.S. has increased fourfold. One-third of most medical products are produced abroad, and with over 150 countries designated as “developing countries”, the FDA has to make sure that the regulation standards in many of these countries are equivalent to U.S. standards.

– In addition to medical products and devices produced abroad, 80% of the active ingredients in most pharmaceuticals are also produced in countries outside of the U.S. Therefore, most all medicines distributed by pharmaceuticals companies contain ingredients sold from foreign countries. This is especially a problem if the regulations in some of these countries are relaxed and the ingredients are mislabelled or contaminated. One story in particular states that in the 1930s a certain medicine contained a poison that killed around a 100 people. Since then, the FDA has taken considerable effort to try and regulate the importation of medicines and pharmaceutical ingredients.

– In some of the poorest countries that still have a strong medical device manufacturing and pharmaceutical industry have several issues in complying with the global market regulations, including a weakly monitored staff, weak surveillance systems, or even no judicial legislation that would regulate product safety. Some of these countries may import a lot of medical devices and products to the U.S. but within themselves may unable to regulate the safety of these products due to weak infrastructure and a limit of available resources.

The FDA has always been required to monitor and regulate the importation of health products and devices, and even though foreign health product regulation may be deficient in comparison to the U.S. oversight, the FDA still has an obligation to ensure that all medical devices and products pass rigorous testing and annual analysis to ensure the public safety and health of the U.S. citizens who rely their lives upon some of these products.

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Category: Medicines and Remedies
Keywords: FDA Reporting for Safer Medical Products ,CDRH