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審核方法（2023年更新）
2023年4月1日發(fā)布了MDSAP（醫(yī)療器械單一審核程序）審核方法的更新版本，適用于MDSAP所有成員國的監(jiān)管機構(gòu)：澳大利亞藥品管理局、巴西國家衛(wèi)生監(jiān)督局、加拿大衛(wèi)生部、日本厚生勞動省和獨立行政法人藥品和醫(yī)療器械綜合機構(gòu)、以及美國食品藥品監(jiān)督管理局。
指南具體說明了如何根據(jù)MDSAP審核程序進(jìn)行審核，包括審核流程以及審核各項具體環(huán)節(jié)的指示，并確定了突出各環(huán)節(jié)之間相互作用的連接點。MDSAP審核流程包含4項基本環(huán)節(jié)以及2項附加環(huán)節(jié)。
MDSAP審核流程的設(shè)計和制定，旨在允許有關(guān)方以邏輯性強、重點突出以及效率高的方式進(jìn)行審核。然后，從審核一項環(huán)節(jié)中獲得的信息可用于決定應(yīng)當(dāng)選擇什么用于下一環(huán)節(jié)的審核。
請留意，MDSAP審核程序已為澳大利亞、巴西、加拿大、日本和美國的監(jiān)管機構(gòu)所接受。
京公網(wǎng)安備11010802046783號
