EU Authorised Representative Programme

20 February 2020

Where a manufacturer is based outside the European Community (EC), Competent Authorities must be able to contact an entity or person who is based within the EC, and acts on behalf of a manufacturer. An Authorised Representative is a natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer.

QFI operates a fully documented EU Authorised Representative service designed to meet clients’ needs when placing a product on the European Market. The service is managed by Technical Specialists from Competent Authority and industry backgrounds with relevant adverse incident and compliance enforcement action skills.Key features of the programme are as follows:

  • registration of products with the various Competent Authorities depending on which markets youintend to distribute within
  • Certificate of Appointment, containing product registration details
  • informative EU Authorised Representative Programme Members Pack, with periodic updates
  • initial technical documentation audit to ensure individual Competent Authority procedures are accommodated for your product
  • full adverse incident notification and support
  • annual review of complaints profile for notifications
  • change notification to individual Competent Authorities
  • knowledge of Competent Authority Compliance enforcement provisions.

QFI can provide short or long-term client programmes, including fixed and project pricing, providing a cost-effective service with high technical competence and focus.

Quality First International takes the role of EU Authorised Representative extremely seriously and supports and always defends clients’ interests.

International Representative Program

20 February 2020

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
  • 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:

    • 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

UK Responsible Person Programme

20 February 2020

Where a manufacturer is based outside the United Kingdom (UK), the UK enforcement authorities must be able to contact an entity or person who is based within the UK and acts on behalf of a manufacturer. A UK Responsible Person is an individual or a legal person established in the UK who acts on behalf of a manufacturer established outside the UK in relation to specified tasks regarding the manufacturer’s obligations under the relevant British laws, which may be sector specific. For instance, for medical devices this means the UK Medical Devices Regulations 2002 (as amended in 2019).

A UK Responsible Person assures various legal obligations, duties and liabilities on behalf of a principal such as a medical device manufacturer.

QFI operates a fully documented UK Responsible Person service designed to meet clients’ needs when placing a product on the UK market. The service is managed by Technical Specialists from Competent Authority and industry backgrounds with relevant adverse incident and compliance enforcement action skills. Key features of the programme are as follows:

  • registration of products with the relevant enforcement authority (for example, for medical devices, the Medicines and Healthcare products Regulatory Agency or MHRA)
  • Certificate of Appointment, containing product registration details
  • initial technical documentation audit to ensure the relevant enforcement authority (for example, for medical devices, the MHRA) procedures are accommodated for your product
  • full adverse incident notification and support
  • annual review of complaints profile for notifications
  • change notification to the relevant enforcement authority (for example, for medical devices, the MHRA)
  • knowledge of the relevant enforcement authority (for example, for medical devices, the MHRA) compliance enforcement provisions
UKCA mark
UKCA mark

QFI provides dual services as a UK Responsible Person/UK Authorised Representative, based at our UK offices, to enable manufacturers and other relevant economic operators to be able to continue supplying products to Great Britain.

If you utilise a distributor or a supplier who brings your products to the UK, you may additionally need to confirm their status as an official UK importer. In such cases, QFI can serve in this capacity, too.

Products affected include, among others, medical devices, cosmetics, machinery, toys, personal protective equipment, and hazardous substances.

QFI can provide short- or long-term programmes, including fixed and project pricing, providing a cost-effective service with high technical competence and focus. We take the role of UK Responsible Person extremely seriously, and always support and defend clients’ interests.

UNITED STATES (US) AGENT PROGRAM

20 February 2020

The US Food and Drug Administration (FDA) requires that any establishment engaged in the manufacture, preparation, propagation, compounding or processing of a drug or device imported into the United States of America (USA) be registered with them. Any manufacturer without a place of business in the USA is designated as a foreign establishment and must appoint and register with the FDA, a United States Agent.

QFI has a fully operational office in the USA, allowing them to act as US Agent for device manufacturers, and from where they defend the manufacturer’s interests at all times. Specifically, QFI perform the following tasks on behalf of the manufacturer:

  • Register the foreign establishment and list the devices with the US FDA
  • Assist in communications with the US FDA, including responding to questions posed by the US FDA concerning the products imported into the USA
  • Assist in scheduling inspections of the manufacturers site by the US FDA
  • Handle appropriately any queries received from the US FDA, contacting the foreign establishment where necessary

OFFICIAL IMPORTER SERVICES

15 October 2020

To market medical devices and other consumer products in Great Britain/ United Kingdom and European Union, each manufacturer or distributor located outside the UK, EU member states and under EEA must appoint an official importer pursuant to regulations.

It is necessary to appoint separate official importer in the UK and EU, respectively, QFI official importer services.

QFI’s Official importer service is a programme for medical device manufacturers and distributors who do not have competent suitably- located and qualified persons in either the United Kingdom or/and European Union.

We assume, on behalf of your company, requisite responsibilities additionally ensure legal duties concerning safety and official notification of your products are fulfilled pursuant to applicable market surveillance legislation.

 

EU Authorised Representative Programme
EU Authorised Representative Programme
UK Responsible person
UK Responsible Person Programme