Medical Devices are highly regulated products & different countries have a different regulatory approach for market clearance & sale of medical devices. Medical device varies in size, ease of use, safety ranging from simple bandages, surgical instruments to implants & complex systems involving software.
When a manufacturer decides to enter a new market, he has to consider not only the regulatory requirements of that particular market but also has to determine how those requirements apply to his product. Depending on the risk of the product & intended use, the regulatory requirements will vary.
We Provide Following Regulatory & Certification Services For Medical Device Manufacturers
ISO 13485 Certification Consultant: ISO 13485 is a Quality Management system specifically developed for Medical Devices & related services.
USFDA Certification Consultant:
In the US, the US FDA regulates the sale of medical devices.USFDA Registration is a Necessary Requirement to place your products in the USA. After registration, you are allotted a Registration number which is used by US Custom Authority & Other concerned Authorization in the USA to Established your Actual identity as suppliers to the USA.
CE Mark Certification Consultant: CE marking – In order to market products in the European market, the products must have a CE mark which declares that a product meets the EC directives.
CE Technical File or Design Dossier Compilation and Review:
A CE Marking Technical File or Design Dossier (Class III) is a Containing depiction of your gadget intended to show consistency with European requirements. Compiling your specialized record or plan dossier is a basic advance in Europe’s CE Marking process and a necessity for consistency with the Medical Devices Directive 93/42/EEC, In Vitro Diagnostic Medical Devices Directive 98/79/EC, or Active Implantable Medical Devices Directive 90/385/EEC.
510(k) Certification Consultant & Regulatory Guideline For Medical Devices: Operon Strategist classifies the devices & gathers information about the company the products which are then uploaded through an online process.
TGA & ANVISA Regulatory Affairs For Medical Devices: Therapeutic Goods Administration (TGA) approval – Australia – TGA is the regulatory body for therapeutic goods in Australia & is responsible for conducting assessment & monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard.
CDSCO Regulatory For Import License & Wholesale Registration: The medical device industry in India is regulated by Central Drugs Standard Control Organization (CDSCO) under the regulatory provisions of the Drugs &Cosmetics Act 1940 & Rules 1945.We also help companies get the wholesale license to facilitate the sale of their products in India.