As per FDA regulation, manufacturers, initial exporters, and importers must complete medical device FDA Registration. It is the official process of registering your establishment with the agency. This applies to various types of establishments, including:
- Drug manufacturers
- Medical device manufacturers
- Food processors and packers
- Cosmetics manufacturers
- Tobacco product manufacturers
By registering, you provide the FDA with essential information about your facility, operations, and products. This allows them to monitor your compliance with safety and quality standards and take appropriate action if necessary.