MDSAP 产品分类和注册登记控制程序 产品分类和注册登记控制程序 文件编号版本修订日期密级QP-XXX-XXX D 2022/5/4内部公开 第1页共12页1.目的明确销售市场或地区的医疗器械准入程序，确保医疗器械产品上市销售符合医疗器械法规监管要求。2.范围 适用于企业登记、产品注册等活动。3.职责 3.1产品注册部：负责办理企业...
If you are looking for guidance or assistance with MDSAP certification or compliance, there are several steps you can follow: 1. Understand the MDSAP requirements: Familiarize yourself with the MDSAP requirements and the specific regulatory requirements of the participating countries. This includes unders...
• MDSAP Guidance Documents • Full details of the MDSAP pilot prior to 2017 • Pilot started in January 2014 (for 3 years, to Dec 2016) • Certification Bodies from participating member states can apply to become AO's • Policies, Procedures, Templates and Forms (Policies, procedures...
United States (FDA 21 CFR 820)- FDA will accept MDSAP audit results instead of routine inspections for medical device companies. However, initial visits and "for cause" inspections will still be conducted. Health Canada (CMDR)- As of January 1st, 2019, Health Canada only accepts MDSAP audits...
this guidance refers to standards described in the IMDRF documents as criteria FDA will consider for recognition, rerecognition, recognition denial, rerecognition denial, and withdrawal of recognition of (Third Party) Review Organizations under the (Third Party) Review Program,” states the guidance. ...
MDSAP -audit model 英文法规标准的附件.pdf,MEDICAL DEVICE SINGLE AUDIT PROGRAM AUDIT MODEL 2017-01-06 MDSAP AU P0002.004 2 Table of Contents Overview 5 Audit Sequence 5 Conducting the Audit. 8 Navigating the Audit Sequence … 8 Terminology …. 9 Referenc