Regulatory Information

At our site in Wexford, the regulatory department manages an extensive number and variety of registrations including registration of:

  • health care and medical device products
  • products for human and animal drinking water disinfection
  • veterinary medicinal products
  • food and farm disinfection solutions
  • Medentech holds registrations in over 100 countries, making Medentech’s regulatory team experts in registering disinfectant products in all areas of the globe, from Europe to Australia, and from the US to Asia.

Requirements for different types of disinfectant products vary greatly across the world. In the EU, a CE mark is required to market a disinfectant for use in disinfection of many surgical and medical instruments, where regulation under BPR is required for a general surface disinfectant. Similarly in the US, a general surface disinfectant or drinking water disinfectant requires approval from US EPA, while medical device disinfectants may require a listing with clearance by US FDA. To register a product, a large amount of information must be collated and submitted to the appropriate authorities for review before a product can be sold. Detailed data relating to product composition, safety, toxicology, efficacy, instructions for use, and labelling are among the common data requirements.

Our regulatory team led by Sinead Whelan Buckley strive to ensure products are brought to market as quickly as possible to ensure global access while always ensuring products are fully compliant with all regulations, and most importantly are always safe and effective for use.

Sinead Whelan Buckley
Regulatory Affairs Manager