Medical Device
Showing 1–16 of 19 results
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Brazil’s Anvisa: Compliance Assessment Requirements for Equipment required by the Health Surveillance
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China’s NMPA Decree No. 1 – Annex 3: Guideline on Medical Device Adverse Event Monitoring Scope (Draft)
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China’s NMPA Decree No. 1 – Annex 7: Guideline on Focus Points when Monitoring Medical Device Adverse Events (Draft)
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China’s NMPA Decree No. 131: Announcement on Using Chinese Name for Registrant or File Submitter of Imported Medical Devices
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China’s NMPA Decree No. 6: Guideline on the Design of Clinical Trials for Medical Devices
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China’s NMPA Decree No. 6: Regulation on Instructions for Use and Labels of Medical Devices
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China’s NMPA Decree No. 83: Innovative Medical Device Special Approval Procedure
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China’s NMPA: Announcement on Record Filling of Medical Device Master Files
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FDA Guidance : Acceptance and Filing Review for PMAs
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Japan’s PMDA: C-Reactive Protein Assay Kit Registration Technical Review Guideline
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Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Medical Devices
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PMDA Guideline: Conditional Early Approval System for Innovative Medical Device Products (Fast-Break Scheme) in Japan
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PMDA Guidline: Applications for Marketing Approval related to the Handling of Medical Device Software in Japan
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PMDA: Points to Consider for Reprocessed Single-use Medical Devices
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