For many medical entities, the process of international regulation and approval can be long and confusing. While this is not always an easy process, there are a few things that you should remember whenever you are attempting to get your products approved in a new country.
The International Organization of Standardization
ISO, or the International Organization of Standardization, is the primary supplier of international regulatory standards, but compliance with ISO standards does not guarantee compliance with the rules and regulations of many countries.
Regulatory approval does not have a set timeline. Some countries can approve products within a couple weeks of the initial request while others can easily take longer than a year to complete all of the necessary actions.
The approval timeline can be affected by any number of things. Some countries (like Malaysia) base their standards off of standard ISO requirements. This helps to streamline the process, especially if you are already in compliance with the standards. Many countries (such as China and Japan) have national institutions similar to the FDA (Food and Drug Administration). These require a more focused effort and completion of the process can take months.
Countries, as well as prospective buyers of your product, can require a site inspection or audit of your company prior to approval. This is more common when it comes to Asian countries.
One saving grace of regulation as an institution is the push for consistent worldwide standards. This is an ongoing effort between the ISO, the FDA, and a number of other regulatory bodies to provide global harmonization of regulatory standards. Major standards included in ISO 13485 and 9001 provide general standards for a quality system and are recognized by many countries and companies throughout the world.
Regulatory practices have spread across a number of industries over the last 50 years. As they become more commonplace we can expect a global standard to emerge. It may happen slowly, but we can hope that someday companies will only need a handful of certifications to safely and legally distribute to the entire world.
Michigan Instruments has been the site of incremental development and constant change through the years. Today, our test lungs are recognized worldwide by thousands of users and are considered the gold standard of respiratory simulation.
Contact us to learn more about our array of respiratory products and medical applications today.