China Suppliers and FDA Regulations- Is your Supplier Compliant?

Understanding the rules and regulations of the importing country can be an incredibly important aspect of sourcing, particularly from China. There are many opportunities for incongruities and miscommunications to arise as you are dealing with the relationships between yourself, your supplier, competing regulatory agencies and any intermediary agents or QC inspectors. This is why it is especially important to understand all requirements that are needed of your products and suppliers before moving forward with any project. Most importantly, never make assumptions about what your Chinese manufacturer will be supplying, even if it is stated that it is their responsibility to do so. In fact, you should take this one step further and go through the efforts to verify that what your supplier is providing is compliant with the importing country’s regulatory requirements.

Here are three things to be aware of when dealing specifically with goods covered by the U.S. Food and Drug Administration (FDA) and the corresponding FDA import regulations:

1. Be Sure to Know Which Products are Specifically Covered by the FDA- According to their website they regulate “food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.” Be thorough in your evaluation though as even the most unassuming retail products, such as reading glasses, can potentially fall into these categories and cause problems for you down the line.
2. Verify the Supplier Establishment has been Registered- Whether you are a producer or distributer of the good, if your product falls under their jurisdiction, the establishment must be registered with the FDA (see here for full list of who must be registered). Additionally, once the supplier has given you their registration number, you should verify that the number corresponds to them. If you don’t, don’t be surprised if the FDA turns away your goods at the border because the establishment registration number didn’t match with the name of the supplier provided, as many factories will give the number of another factory that they know is registered.
3. Verify the Device Listing Number- This is a good way to also verify the suppliers establishment registration, as all establishments must list the devices that they provide along with the products’ corresponding device number. If they don’t have the device numbers for their factory, then there’s a good chance they are not registered properly.

One of the biggest dangers in China sourcing is falling prey to misinformation and inadequate preparation. A factory’s biggest concern is getting your business and often this means providing you with the information that you want to hear whether or not it is legitimate. In order to avoid order delays and import issues, conduct the necessary due diligence on your supplier and make sure all qualifications are verified, all registration and device numbers match the supplier, and all FDA regulations adhered to before moving forward on any project.

Have you had any problems with suppliers not complying with FDA regulations? We’d love to hear about your experiences in the comments below.

• Amy Xu- CPG Sourcing Associate