Working with you to provide practical, efficient, focused, expert support to prepare and submit the specific country applications for clinical investigations and/or medical device licensing / clearance to market in Europe, North America, South America, Asia, Australia & New Zealand. This can be accomplished as part of your Regulatory Strategy and/or Clinical Evaluation. In generic terms we support our clients in the required country applications by:
Developing plans for application(s) / submissions;
Classifying the device(s), addressing regulation(s);
Identifying specific national standards required;
Ensuring traceability / manufacturing control standards;
Determining best fit routing and type of application;
Collating the required objective evidence;
Preparing and submitting the necessary documentation to obtain clearance to market or licence as appropriate;
Liaison with country representatives / sponsors / agents, distributors, translators and regulatory agencies;
Registration of the manufacturer / site / device(s) as applicable.
In addition to preparing Clinical Investigation Applications for Russia, Ukraine, Norway, Switzerland and countries within the EC (European Community), we have also addressed specific language and registration requirements for medical device clearance to market. Such services have included;
Preparation and submission of regulatory applications to the relevant Competent Authority or Regulatory Agency;
Liaison with specific country representatives, distributors, translators and regulatory agencies.
Following determinations the UK’s BREXIT we provide advices regarding export requirements to the EC and European countries.
We support our clients to complete the necessary medical device regulatory applications / registrations in;
ASEAN trade bloc; via the ASEAN Agreement on Medical Device Directive (AMDD).
China; via the CFDA Regulatory Approval Process for Medical Devices.
India; via the CDSCO.
South Korea: via the Ministry of Food and Drug Safety (MFDS).
Taiwan via the Taiwan (TFDA) Regulatory Approval Process for Medical Devices.
In addition to preparing device Investigational Testing applications for Canada and Investigational Device Exemption applications for US, we assist our clients to obtain the necessary clearances to market for:
US: via the FDA’s 510k, PMA or DeNovo process.
Canada: we ensure CMDR compliance, obtain Medical Device Establishment License (MDEL) and Canadian Medical Device License (MDL) for your devices.
In addition to preparing device Investigational Testing applications for Brazil and Mexico, we assist our clients to obtain the necessary clearances to market for;
Brazil: via the ANVISA Regulatory Approval Process.
Mexico: via the COFEPRIS Approval Process for Mexico.
Australia & New Zealand
We provide the support, complete the applications medical device regulatory applications / registrations in:
New Zealand: via the Medical Device Safety Authority (MedSafe) Medical Device Registration process.
Australia: via the Therapeutic Goods Administration (TGA) Regulatory Approval Process for Medical Devices.