8/20/2019

Documentfile

Document Title Group Type No Version Comment Download
Criteria for Supplying After Sales Services by Medical Device Companies All Audiences Instructions
Criteria for Third-Party Medical Device Companies Supplying After-Sales Services All Audiences Instructions
Directive of Medical Devices All Audiences Instructions
Executive instruction on the Formulation of Medical Devices Standard All Audiences Instructions
Instruction for Disposing the Orthopedic Implants All Audiences Instructions
List of Harmonized Standards for Medical Device All Audiences Instructions
Mandatory Standards and Technical Requirements for Registration of Medical Devices All Audiences Instructions
NB Ranking according to 98-79-EC All Audiences Instructions
Procedural Directive of Initial Approval of Issuance for Activities in the Field of Provisioning Qualitative Control of Medical Device All Audiences Instructions
Procedure for soliciting a joint meeting with foreign nationals by the applicant companies All Audiences Instructions
Criteria of Adverse Events Report and Recall of Medical Device All Audiences Instructions
Executive Instruction of Made in Iran All Audiences Instructions
Instruction for contractual production of medical device All Audiences Instructions
NB Ranking according to 93-42-EEC All Audiences Instructions
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