Most regulatory agencies around the globe require representation within the country or region for foreign device and pharmaceutical manufacturers. Through our subsidiary offices and extensive industry network we are able to provide in-country representation in most major markets.
United States – US Agent
Our headquarters located in the Tampa area in Florida. We are setup to provide US Agent services for both medical device and pharmaceutical product manufacturers marketing devices in the United States.
European Union – Authorized Representative
Our office in Düsseldorf, Germany was established to increase our presence in Europe with a focus on providing regulatory, quality management, and business development consulting to life-science startup companies in Germany and surrounding Member States. Additionally, this office will serve as Authorised Representative for manufacturers seeking to expand commercialization of health products to the European Union.
United Kingdom – UK Responsible Person
Following BREXIT, all medical device manufacturers marketing products in the UK requires to appoint a UK Responsible Person (UKRP). Our office in London is set up to support the manufacturer and device registration requirements under the UK medical device regulations as well as to serve as the UKRP and correspondent with MHRA.
Australia and New Zealand – Medical Device Sponsor
We have established offices in both Australia and New Zealand specifically to provide in-country representation as well as device registration. Both Therapeutic Goods Administration (TGA) in Australia and New Zealand Medicines and Medical Devices Safety Authority (Medsafe) require a “sponsor” to submit and account for medical device, pharmaceuticals, and dietary supplements. Similar to the Authorized Representative services in the EU, we serve as the liaison between the authorities and the manufacturer, to initiate any adverse events or recalls. Additionally, the sponsor is legally responsible for the devices placed on the market in these regions and therefore takes on additional visibility and collaboration with the authorities.
While India has had a mature regulatory infrastructure for pharmaceuticals, The government has recently (2017) approved the new medical device regulations for the country. And is set for full implementation by January 2018. Our office in Gujarat has been established for several years and is licensed as a wholesale distributor. It provides India Authorized Agent for our clients seeking to perform clinical trials, CDSCO product registration, or distribution of medical devices and pharmaceuticals in India. Please do let us know if you have interest in marketing your product in this major healthcare consumer market.
Switzerland – Authorised Representative
Starting 26May2021, Switzerland will no longer recognize authorised representatives (AR) outside the country. Our office in Zurich was established to serve in that capacity for medical device and IVD manufacturers who are required to appoint a Swiss AR in order to place their devices on the Swiss market. This registered branch of our office in Germany provides both AR and product registration services. At the present time, only a small sub-set of devices require registration themselves, but all devices, regardless of risk classification require the appointment of an authorised representative in Switzerland.
Brazil is the largest medical device market in Latin America and attracts an increasing number of manufacturers. To market medical devices/ IVDs in Brazil, manufacturers must get previous approval from the Brazilian Health Regulatory Agency (ANVISA). ANVISA is a member of the IMDRF and MDSAP, aiming to establish a regulatory convergence with the main regulators worldwide. The complexity and costs associated with the medical device/ IVDs registration in Brazil depends on the device’s classification, as well as whether any additional certifications are required. Such as INMETRO (Technology, Quality and Metrology National Institute) and/or ANATEL(Telecom national agency).
The Brazilian legislation establishes that only national companies are able to register medical devices/ IVDs. But these companies must have local and federal sanitary licenses. The Brazilian Registration Holder (BRH) is responsible for the product registration in Brazil and acts as a link between your company and ANVISA. Our strategic partner office in Porto Alegre is ready and available to support your international market expansion to Brazil.
Our extensive network of consultants and channel partners are able to introduce and in most cases secure in-country representation in other global regulatory regions. Our partners have locations throughout Asia, Middle East, Africa, Latin America, and Russia.