Medical devices have to meet all the FDA regulations before being imported into the United States. One of the primary steps that foreign medical device manufacturers have to be aware of is that FDA does not identify regulatory sanctions from the foreign countries.
The term “medical device” under the Food Drug and Cosmetic Act (FDCA) implies to instruments, machines, implants, in vitro reagents, and comparable or related articles, including component parts or accessories, which are:
- Intended to be involved in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of the disease in man or animal.
- Intended to affect the construction or any function of the body of man or animal, and the one which does not accomplish any of its principal intended purposes through chemical action within or on the body, and is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
Medical devices fall into one of the three classes as follows:
- Class 1 medical devices are the ones with the lowest level of hazard linked with them. If a Class 1 medical device fails or becomes defective, there would be no significant injury or harm to the patient or the user.
- Class 2 medical devices carry greater risk. If a Class 2 medical device fails or becomes defective, there would be a risk for the patient or the user to get injured or harmed.
- Class 3 medical devices carry the greatest risk. If a Class 3 medical device fails or becomes defective, there would be a risk of serious injury or death to the patient or the user.
FDA categorizes medical devices and, in numerous cases, has dispensed regulations affirming the classifications and requirements for these. Nevertheless, as the medical device technology moves ahead, in many cases, a new medical device does not fall easily into an existing medical device classification or category. Therefore, there is a regulatory process in which all the medical device manufacturers and distributors should ask FDA to classify a new medical device.
Importers of medical devices have to also register with the FDA as device establishments stand-in as medical device initial distributors. FDA expects the U.S. importers to comprehend and ensure compliance with the FDA laws and regulations linked to the medical devices, medical device manufacturing, and medical device clearances (510(k) s) and FDA approvals (PMAs) when mandatory.
For more on FDA regulations and customs requirements for import of the medical device or products, join Dr. Rossano V Gerald in a Live Webinar on Wed, Aug 31, 2016. During the session, Dr. Gerald will provide guidance on how to access FDA agency documentation while addressing the strict requirements of imports of goods for health and safety reasons. Attendees will receive guidance on U.S. Customer Border Protection regulations for the international logistic transactions.