Anson Group offers services to US and international medical technology companies to aid them in compliance with certain registration and licensing requirements of the FDA and Health Canada.
Pursuant to 21 CFR 807.40, FDA requires that any establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device imported into the United States must register with FDA and identify the name and address of the establishment and the name of the United States Agent for the establishment.
Foreign establishments must designate a United States Agent who is either a resident of the United States or maintains a place of business in the United States. The foreign establishment may, but is not required to, designate its United States Agent also as its Official Correspondent.
The United States Agent’s responsibilities include:
- Assisting FDA in communications with the foreign establishment
- Responding to questions concerning the foreign establishment’s products that are imported or offered for import into the United States
- Assisting FDA in scheduling inspections of foreign establishment
- Accepting information or documentation from FDA on behalf of the foreign establishment, if FDA is unable to contact the foreign establishment directly or expeditiously. FDA may provide information or documentation to the United States Agent and such action shall be considered the equivalent of providing the information to the foreign establishment.
Health Canada is the regulatory body in Canada that oversees the marketing of medical devices, drugs, biologics, and radiopharmaceuticals. Through Anson’s close contacts with Health Canada authorities, we can provide device, drug and biologics manufacturers with specific classification information and compliance requirements for their products.
- Licenses are required to market non-exempt products listed as medical devices under Health Canada’s classification system, as are licenses for amendments to products already licensed for sale. Approved licenses are renewed on an annual basis.
- Certain medical devices are exempt from license requirements, but manufacturers who do not have a licensed Canadian distributor must obtain Health Canada Establishment licenses to market them in Canada.
- Drug products, including prescription and non-prescription pharmaceuticals and disinfectants, as well as vaccines and biotechnology and radiopharmaceuticals all require pre-market approval by Health Canada.
