MCRA RESOURCE CENTER

-

-

-
 
  -
 

REGULATORY

Technologies often arise to fame in the European and Foreign markets, therefore, understanding and being able to get a device CE marked is essential for many companies to develop their market place. Additionally, a proper quality system is mandatory to bring devices to the worldwide orthopedic markets.
 
 
 

QUALITY ASSURANCE & INTERNATIONAL REGULATORY

General International Regulatory Affairs

• International Regulatory Authority

• Search for Medical Devices Establishment Licenses

• Search for Active Medical Devices Licenses

• Notified body recommendations

• Universal Medical Device Nomenclature System (UMDNS) codes


Europe

• European Directives including the Medical Device Directive (MDD)

• Guidelines relating to medical devices Directives (MEDDEV documents)

• List of harmonized standards for the Medical Device Directive (MDD)

• Translation of the German Gesetz über Medizinprodukte (MPG)


Asia

• For China and Japan

• For India, Hong Kong, Taiwan, Singapore and Malaysia

Canada

• Canadian Medical Device Regulation

• Canadian Medical Device Guidance Documents

• Application information for Health Canada