Regulatory Liaison Services for Medical Devices

To communicate effectively with regulatory bodies, it is vital to choose a representative who is an expert on the regulatory framework applicable to your product to act in your best interest.

In many countries, including the United States and Canada, the risk-of-use level of a medical device is directly proportional to the level of regulatory control applicable for that device. As an already highly regulated industry, medical devices require effective communication with the regulatory bodies responsible in the country in which the manufacturer intends the device to be sold. Many regulatory bodies may even require companies to appoint a representative for the medical device in these countries.

dicentra has extensive experience in regulatory affairs for medical devices in both the United States and Canada.

Our in-country regulatory liaison services for medical devices include the following:

Regulatory Liaison Services in the USA

  • Facilitate interaction with regulatory agencies during development stages, submissions, and submission approval process
  • Liaison with regulatory agencies on regulatory, CMC, clinical, and toxicology matters
  • Respond to regulatory agency questions
  • Represent you during agency audits
  • Medical device vigilance and adverse event reporting services

Regulatory Liaison Services in Canada

  • Organize and manage meeting(s) with the Therapeutic Products Directorate (TPD)
  • Liaison with Health Canada during submissions and submission approval process
  • Respond to regulatory agency questions
  • Resolve regulatory compliance issues
  • Represent you during Health Canada inspections and audits
  • Medical device vigilance and adverse reaction reporting services

For more information on how dicentra can assist you with our regulatory liaison services please contact us using the form below