Quality First International will:
- Register your products
- Assure regulatory compliance
- Handle enquiries from government, health service, media, etc.
- Co-operate with investigation of alleged adverse events
- Maintain and retain accurate records
- Fulfilling requisite transparency, protecting intellectual property and avoiding conflicts of interest
- Conducting communications with authorities and other third parties ethically and consistent with foreign corrupt practices legislation
- Fulfilling local requirements to maintain access to technical documents, etc
- Ensuring lawful promotion
Medical device regulation around the world increasingly dictates a legal presence in a country in order to do business there. Selling products through a sales representative or distributor is no longer adequate in certain countries. Paralleling the European Union Authorised Representative system, some countries require that where a manufacturer is based outside the country, there must be a legal representative within the country with whom they can communicate and who is authorised to act on behalf of the company. Professional International Representative Program must be aware and adept in operating in the regulated environment, cognisant of regulations and able to guide compliance.
The International Representative Program acts on behalf of the company and must be able to conduct both routine communications with authorities and emergency duties, including such unfortunate events as recalls. Therefore, the International Representative Program must be able to converse and communicate the interests of your company, understand subject matter fully, including regulatory framework, product complexity, concomitant potential for harm and respective conditions concerning post-market obligations, product retrieval and disposal, etc. They must be able to deal with all stakeholders on behalf of the principal.
QFI’s International Representative Program fulfills these and several other functions, including executing recalls, registering product, etc to help our principals by: