MEDICAL DEVICE RULES医疗器械的规则.doc

MEDICAL DEVICE RULES, 2013CONTENTSPART-IPRILIMINARYShort title and commencement Definitions PART IICONFORMITY ASSESSMENT PROCEDURERequirements and procedures for conformity assessment for the purpose of medical device registrationPART IIIREGISTRATION OF CONFORMITY ASSESSMENT BODYRequirements for registration of conformity assessment bodyApplication procedure for registration of conformity assessment bodyRegistration of conformity assessment bodyRenewal of registration of conformity assessment bodyChanges concerning registered conformity assessment bodyCertificate of registration of conformity assessment bodyCompliance with conditions of registration of conformity assessment bodyCancellation or suspension of registration of a conformity assessment bodyResponsibility of the Board with regard to certificates issued by the Conformity Assessment bodyPART IVESTABLISHMENT LICENSETypes of establishment licenses Application procedure for establishment licenseProcedure for establishment license Conditions for establishment licenseRenewal of establishment licenseChanges concerning establishment licenseCompliance with conditions of establishment licenseCancellation or suspension of establishment licensePART VREGISTRATION OF MEDICAL DEVICEMedical Device RegistrationClassification of medical devicesProcedure for application for medical device registrationProcedure for registration of medical deviceRenewal of registration of medical deviceChanges concerning registered medical deviceCertificate of registration of medical deviceCompliance with conditions of registration of medical deviceCancellation or suspension of registration of medical deviceAdditional requirements for registration of medical devices for clinical investigationPART VIIMPORT AND EXPORT Import of medical devices.? Permit to import medical device components and raw materials Permit for import of components or raw materials manufactured by one manufacturer. Application for import permit.? Import Permitting Autho