Contact

Version Française

 

Europe 93/42/EC and 98/79/EC directives MD EC mark  (dir 93/42) IVDD EC mark (dir 98/79)		USA FDA - CDRH 21 CFR Quality System Requirements Medical devices registration 510(k) Pre market approval FDA inspection
FRANCE Adverse side effects notification Device registration Special authorization prior marketing Clinical investigations		CANADA Medical devices registration

 

 

Medical devices registration

 

REGULATION

New Medical Device Regulations (Canada Gazette, Part II, May 27. 1998).

Evaluation by Health Canada

ISO 13485 certification is now required to register medical devices.

 

Classification

Class I : Surgical Instruments

Class II : Non invasive Medical devices, dental devices, short-term medical devices,

Class III : Long term implantable medical devices

Class IV : Diagnostic / active / control long-term implantable medical devices

 

Registration Files

Class I : Marketing declaration

Class II : Homologation procedure (identification, description of the medical device, conformity to the essential requirements, labeling and certified quality system)

Class III : Homologation procedure idem class II + biocompatibility, validation of sterilization, clinical evaluation and market history.

Class IV : Homologation procedure idem class II + Risk Analysis, Quality control, Manufacturing process.

 

Go to Regulatory Services Click

Links and documents Click