MDSAP
MDSAP
4. Medical Device Single Audit Program (MDSAP)
協助國內廠商通過MDSAP醫療器材單一稽核方案
The Medical Device Single Audit Program was developed by a group of medical device regulators to allow recognized third-party auditors to conduct a single audit of a medical device manufacturer that will cover ISO 13485 and their respective regulatory requirements.
More information and documents about the International Medical Device Regulators Forum (IMDRF) and MDSAP are available on the IMDRF website and on the FDA’s website.
The regulatory authorities that are currently participating in the MDSAP Pilot Program are:
• Australia - TGA
• Brazil - ANVISA
• Canada - Health Canada
• U.S. - FDA
• Ministry of Health, Labour and Welfare (MHLW) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)
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