Clearances and Approvals
Global Market
In addition to the USA and Europe, Canada, Asia and Latin America represent an extremely attractive market for many medical device, IVD, and biotechnology companies due to two key elements – dense populations and rapid economic growth. As a result, exponential market growth has been experienced by many of our clients who have tailored their quality systems and prepared product filings to meet the dynamic regulations.
If your company is interested in getting started in Canada, Asia or Latin America, or expanding from one country to several, The CRO Group may be able to assist you in:
– Familiarisation/Training in Key Regulations of Asia (Japan, China, Taiwan, Korea) and Latin America (Mercosur)
– Preparing registration files for importing medical devices and IVDs
– Providing infrastructure (ie Japan MAH) services
FDA
The CRO Group assists in preparation and submission of product approval applications including 510(k) Premarket Notifications and PMA Premarket Approval Applications, as well as 513(g) determinations and DeNovo petitions. For more information on our 510(k) services and other submission support services, or if you would like a quote for FDA Clearances and Approvals, click here.
CE Marking
In Europe, the type of product for which you are seeking CE Mark is addressed by regulations agreed upon by each of the Member States known as Directives. The three general directives affecting medical devices in Europe are:
– AIMD Active Implantable Medical Device Directive Implanted defibrillators, drug delivery systems, pacemakers, etc.
– IVDD In Vitro Diagnostic Directive IVD reagents, controls, calibrators, systems
– MDD Medical Devices Directive All other medical devices
*Compliance with AIMD and many times with MDD or IVDD requires proof of product essential requirements conformity plus quality systems certification by a 3rd party assessment agency known as a Notified Body. What determines whether or not such certification is required is the level of risk of the products. In addition to Quality Systems (ISO 13485) certification, product related requirements may be subject to review by a Notified Body, or the company may be required to comply on “their own”.
For a quote on how your company can aquire CE Marketings, click here
Technical Files/Design Dossiers
The CRO Group can help you prepare the technical files required for CE Marking for all products. By using one of our three programs, it is assured that the technical files will be prepared the way your Notified Body expects, including all the checklists, summaries, and support information. Technical files generally include Declarations of Conformity and certifications of test compliance from accredited agencies such as UL, CSA, TUV, etc. For a general explanation of the types of testing involved, click here.