Are you importing medical devices or planning to import them? Medical devices are one of the many industries regulated by the Food and Drug Administration (FDA) and the regulations are complicated, confusing and new ones are constantly emerging. Delays and additional costs can result when an importer fails to understand the regulations or classifies their medical device incorrectly. Keep in mind that as the importer you will work with the FDA directly to determine the Class of your medical devices, while your customs broker can help you classify your medical device for customs purposes to ensure you are paying the appropriate duty and taxes. Gallagher Transport has over two decades of experience working with the FDA and helps importers every day navigate the complex world of FDA regulations.
When it comes to importing medical devices, the FDA closely monitors the classifications and various levels of strictness apply. The FDA in their Code for Federal Regulations (CFR) has set up groupings for roughly 1,700 distinctive generic types of gadgets and gathered them into 16 medical specialties that are called panels. All said generic types of gadgets are assigned to one of the three regulatory classes depending on the level of control required to guarantee the security and effectiveness of the respective gadget. These three classes are:
Device Class and Regulatory Controls
- Class I (General Controls)
- With Exemptions
- Without Exemptions
- Class II (General Controls and Special Controls)
- With Exemptions
- Without Exemptions
- Class III (General Controls and Premarket Approval)
Class I gadgets are regarded safe. Class I gadgets are subject to the fewest administrative controls. A stethoscope s is an example of a Class I gadget.
Class II gadgets are considered a higher hazard level gadget than Class I and require more regulatory controls confirming the specific gadget’s security and viability. For instance, contact lenses are classified Class II gadgets.
Class III gadgets are the most hazardous gadgets and consequently are subject to even more strict regulatory controls. Class III gadgets must be endorsed by FDA before they are advertised. For instance, substitution heart valves are named under the Class III gadgets category.
Step-by-step instructions to Determine Classification
The FDA uses intended use and indications for use to determine Device classification. Class determines several things, including the type of premarketing submission/application required for FDA clearance. You can read more about the definition of intended use here: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)].
To classify your gadget and to find out if any exemptions exist, you have to locate the regulation code or number that is the classification regulation for your gadget. You can specifically go to the classification database and look for the gadget name. If you know the gadget panel to which your device belongs, go directly to the listing of that panel and identify your item.
Examples of different panel categories include
If you know the appropriate panel already, you may go to the CFR directly and discover the grouping of your gadget by reading the list of classified devices. If you’re not sure, you can use the keyword directory in the “Product Code Classification Database.” In most of the cases, the database will be effective in recognizing the classification regulation in the CFR and has the information you require.
For example, if you want to classify a thermometer, in the Classification Database under “thermometer,” you’ll see several sections for various sorts of thermometers. When you recognize the right classification regulation go to ‘What are the Classification Panels’ section and select the correct classification regulation or simply go to the CFR Search page.
Every classification panel in the CFR starts with a list of gadgets classified in that panel. Each grouped gadget has a 7-digit number related with it e.g. 21 CFR 880.2920 – Clinical Mercury Thermometer. When you discover your device in the panel’s beginning list, go to the segment indicated.
It will depict the gadget and will tell you about its class (in this example it is Class II). There is an Item code with three letters “FLK,” in the database for Clinical Mercury Thermometer. This item code is also the classification number used in the Medical Device Listing form.
Around 572 or 74% of the Class I gadgets are excluded from the premarket notification process. These exceptions are recorded in the grouping regulations of 21 CFR. Furthermore, these exceptions are also gathered in the Medical Device Exemptions document.
Need help Importing Medical Devices?
Sound complicated? It is. But Gallagher Transport can help. Give us a call or email us and our team of experienced brokers is happy to assist you getting the answers you need regarding importing medical devices regulations. Call or 303-365-1000 or email us