While most packaged foods are only subject to US Customs and Border Protection (CBP) and Food & Drug (FDA) prior notice filings, some can also be subject to USDA. An experienced Customs Broker comes in handy when importing packaged foods.
Example:
Dry soup mixes may contain meat products and therefore would require a United States Department of Agriculture (USDA) filing as well.
Pharmaceutical Rx Drug Import
Pre-Launch Activities Importation Requests (PLAIR) describes the FDA’s policy regarding requests for the importation of unapproved finished dosage form drug products by an applicant preparing the product for U.S. market launch based on anticipated approval of a pending new drug application (NDA) or abbreviated new drug application (ANDA). It also applies to unapproved biologics licensing applications (BLAs) regulated by the Center for Drug Evaluation and Research (CDER), and unapproved combination products assigned to CDER (21 CFR part 3) for which NDA, ANDA, or BLA approval is anticipated.
Medical Device
Medical Devices are divided into 3 classes (I, II, III)
If the device has electrically powered components, regardless of whether those components are in contact with the patient or not, you will need to evaluate its electromagnetic compatibility (EMC).
Basically, you’re looking at whether your device interferes with other devices (either deliberately or accidentally) or can be interfered by other devices.
