Ge-Shen Group has FDA registered facilities
The FDA is the perhaps the best-known regulatory body of its kind, responsible for ensuring the safety of medicines, medical devices, and food. When it comes to these critical products, the FDA is synonymous with quality and trust. The FDA requires all imports of these products to be well documented and accountable so that any issues can be traced back. Registration and listing provide the FDA with the locations of medical device establishments and the devices manufactured at those establishments.
Ge-Shen is proud to have FDA registered manufacturing facilities, we understand the regulatory requirements and know how to ensure that your medical or food grade products can be manufactured and delivered without worry. Combined with our ISO 13485 quality systems, we can ensure confidence, trust and accountability for products manufactured by us.
We can work together to register your products whether they are exempt or have:
- Premarket Notification (510(k)) number
- De Novo (DEN) number
- Premarket Application (PMA) number
- Product Development Protocol (PDP) number
- Humanitarian Device Exemption (HDE) number
Do get in touch with us to see how we can help, we offer: