MDSAP AUDIT APPROACH 2023 UPDATE
Last April 1st, 2023, was issued an updated version of the MDSAP Audit approach applicable to all country members of the program: Therapeutic Goods Administration of Australia; Brazil’s Agência Nacional de Vigilância Sanitária of Brazil, Health Canada, Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency and The U.S. Food and Drug Administration
The guideline contains specific instructions for performing audits under the MDSAP program. It includes an audit sequence, instructions for auditing each specific process, and identifies links that highlight the interactions between the processes. The MDSAP audit sequence has four primary processes and two additional processes.
The MDSAP audit sequence was designed and developed to allow for the audit to be conducted in a logical, focused, and efficient manner. Then, information learned during the audit of one process will be used to make decisions about what to select for audit during the next process.
Remember that the MDSAP audit program is recognized by all Health Authorities in markets such as Australia, Brazil, Canada, Japan, and the USA. Therefore, if you are interested in fulfilling the MDSAP requirements and bringing your products to any or even all these markets, Osmunda can support you!
MDSAP审核方法（2023年更新）
2023年4月1日发布了MDSAP（医疗器械单一审核程序）审核方法的更新版本，适用于MDSAP所有成员国的监管机构：澳大利亚药品管理局、巴西国家卫生监督局、加拿大卫生部、日本厚生劳动省和独立行政法人药品和医疗器械综合机构、以及美国食品药品监督管理局。
指南具体说明了如何根据MDSAP审核程序进行审核，包括审核流程以及审核各项具体环节的指示，并确定了突出各环节之间相互作用的连接点。MDSAP审核流程包含4项基本环节以及2项附加环节。
MDSAP审核流程的设计和制定，旨在允许有关方以逻辑性强、重点突出以及效率高的方式进行审核。然后，从审核一项环节中获得的信息可用于决定应当选择什么用于下一环节的审核。
请留意，MDSAP审核程序已为澳大利亚、巴西、加拿大、日本和美国的监管机构所接受。
