About Lee Leichter Expertise Manufacturing, Outsourcing, Regulatory (FDA), Quality systems and problems, Exporting, Start-up Issues, strategic planning, Distribution, etc.
Experience Employment history: Over 25 years in the industry
Question Hi,
I'm considering starting an import/export business in disposable medical supplies- mainly
gloves, gowns, masks, etc.
Are there any specific regulations I need to be aware of?
Thank you for any help,
Christine
Answer Hi Christine,
The laws that apply to medical devices are the responsibility of the Food and Drug Adminstration (FDA). There are several regulations that apply to importing and exporting. How much you have to do will be based on the product and whether it is already cleared or approved for sale in the USA. For export, it depends on the country to which the product will be exported and whether it is approved in this country.
The FDA center that is responsible for these products is the Center for Devices and Radiological Health (CDRH). The FDA website (www.fda.gov) and the CDRH site (www.fda.gov/cdrh)in particular are good places to start.
There is also a Division of Small Manufacturers Assistance (DSMA) (1-301-594-4618) that can be called for specific help. It is free.
If you have more general questions, you can contact me directly (941-768-1118 /e-mail leichter@pipeline.com).
