Going Abroad? International Registrations for Medical Devices

by | Feb 23, 2018 | Medical Devices, Uncategorized

Posted By: Stephanie Bouzounis, Senior Communications Specialist

Medical device manufacturers have much to think about when it comes to registering a product internationally. Different regions and countries have different standards for registration. With the impending divorce of the U.K. from the European Union, there are even more considerations to be made. For comparison, the Food and Drug Administration (FDA) states that entities involved in the production and distribution of medical devices in the United States, even those imported and exported, are required to annually register with the FDA.

Here is an overview for the things to look for when registering a medical device globally:

North America

“Registering a medical device in Canada should be a speedy process. Canada is similar to the United States in terms of the process, tests, and protocols it uses. Additionally, there is a mutual recognition between Canada and the United States regarding inspections,” said Ed Rozynski, Senior International Advisor for the Medical Device Manufacturers Association (MDMA), in correspondence with EMMA International. Registering a medical device in Mexico is not generally a difficult process. A Class I, Class II, or Class III medical device manufacturer approved by the FDA for sale in the United States can apply for registration in Mexico without submitting the extensive technical data paperwork required. However, according to Rozynski, it is more challenging to get reimbursement for a product in Mexico.

Europe

On Tuesday, February 20th, MDMA’s International Working Group hosted a conference call with Phil Brown, Director of Regulatory Affairs for the Association of British Healthcare Industries (ABHI). The latest European regulation and directives were discussed. One of the major updates is that certifications issued per the medical device directive now have a shelf life of four years. Any changes to devices now must go through a process of reassessment. Additionally, these directives and regulations now strengthen post-market surveillance, and reinforcement of rules on clinical evidence. The matter of Brexit and medical device registration is still on the table. Brown stated in the MDMA call that there are no new updates regarding these regulatory issues. He did state that the U.K. may seek to strengthen a relationship with the United States as a result, and there is always the possibility the U.K. could vote to stay in the European Union (EU).

Asia

Rozynski stated there needs to be a lot of patience on the part of the manufacturer when registering a medical device in Asia. Each country is different. For instance, Japan has the longest process. Registration is straightforward in Korea. Korea is a good place to perform clinical trials not just for use in Korea, but globally. Reimbursement in Asia, however, is becoming a larger issue.

For more information and/or questions on international medical device registrations that were not answered here, please call (248) 987-4497or email info@emmainternational.com.

Interested in more? Check out these blogs on our website:

Emma International

Emma International

More Resources

Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.
Sterilization of Medical Devices

Sterilization of Medical Devices

There are many ways to sterilize medical devices before use in the industry. The common methods utilized are steam, radiation, dry heat, ethylene oxide, and vaporized hydrogen peroxide. There are two methods of sterilization for medical devices recognized by the Food and Drug Administration (FDA), established and novel.

Ready to learn more about working with us?

Pin It on Pinterest

Share This