台灣醫療器材法規
進口醫療器材，國外醫療器材製造廠應先取得QSD國產醫療器材，國內醫療器材製造廠應先申請QMS醫療器材委託製造: 依 < 醫療器材管理法 > 第23條規定，醫療器材製造業者，非經中央主管機關核准不得委託其他製造業者製造或接受委託製造醫療器材 。
歐、美醫療器材製造廠申請QSD
簡化模式
TFDA已經正式公告第三代臺歐醫療器材技術合作方案 (簡稱臺歐TCP III) 申請作業
- 因應歐盟實施醫療器材法 (Medical Device Regulation , MDR)
- 體外診斷醫療器材法 (In-Vitro Diagnostic Regulation, IVDR)
- 英國脫歐
現行臺歐TCP II預定於MDR施行日 (109年5月26日) 前1日結束。台歐TCP III正式啟動，簡化模式申請請參閱第三代台歐醫療器材ISO 13485與QMS查廠報告交換技術合作方案之歐盟代施查核機構清單。
精要申請模式
- 進口第一等級醫療器材，部分醫療器材經公告，直接上網登錄即可。應以登錄方式取得上市許可之醫療器材品項 ，請參閱衛福部公告：※自110年10月1日起，部分第一等級醫療器材品項實施登錄制度。
- 其他非上述醫療器材，應先申請QSD，才可進行第一等級查驗登記。第一等級醫療器材申請QMS，採精要申請模式(以醫療器材品質管理系統準則第78條附表所列者為限)
- 依據醫療器材管理法第二十二條、醫療器材製造業者設置標準、品質管理系統準則。衛生福利部(衛福部)分別於106年6月16日及108年1月4日公告輸入醫療器材國外製造廠實地檢查之優先實施品項及時程(衛授食字第1061101489、1071106133號)，分年分階段規定「心臟瓣膜置換物（E.3925）」（自107年1月1日起）、「血管移植彌補物（E.3450）、角膜彌補物（M.3400）、被動式肌腱彌補物（N.3025）」（自108年1月1日起）及「植入式心律器之脈搏產生器（E.3610）」（自109年1月1日起）等品項，應申請國外醫療器材製造廠實地檢查。
- 除新申請案外，後續追蹤管理並由衛福部食藥署每年函知次年度應實地檢查之國外醫療器材廠之代理商(藥商)預定檢查時程。
- 生產無類似品、複雜醫材、使用族群多且影響層面大醫材、不良上市後監測結果及不良品通報醫材、QSD文件有疑慮之案件，將考量產品風險、使用數量等因子排序查核名單後，由衛福部食藥署函知次年度應實地檢查之國外醫療器材製造廠之代理商預定檢查時程。
申請流程
- 分類分級判定: Class I (低風險)、 Class II (中風險)、Class III (高風險)
- 品質系統文件準備
- 向TFDA提出申請
- 專業問題回覆
- 收到核發的QSD或QMS核准函
醫療器材優良運銷準則 (GDP)
《醫療器材管理法》第24條規定，「醫療器材販賣業者依規定應建立醫療器材優良運銷系統，並報中央主管機關檢查合格，取得運銷許可後，始得批發、輸入或輸出。」本公司提供醫療器材進出口商之GDP之建置與輔導，內容包含：
- GDP教育訓練。
- 建立優良運銷系統程序書。
- 輔導公司將GDP落實，包含人員、儀器設備、醫療器材進貨、運輸方法、倉儲環境。
- 模擬評鑑之內部稽核，確認文件完整性和正確度。
- 協助醫材運銷許可申請。
- 評鑑後缺失改善與回覆。
美國醫療器材品質系統請參閱
Part 820_quality system regulation_CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION EPARTMENT OF HEALTH AND HUMAN
SERVICESSUBCHAPTER H--MEDICAL DEVICES
Subpart A--General Provisions
§ 820.1 - Scope.
§ 820.3 - Definitions.
§ 820.5 - Quality system.
Subpart B--Quality System Requirements
§ 820.20 - Management responsibility.
§ 820.22 - Quality audit.
§ 820.25 - Personnel.
Subpart C--Design Controls
§ 820.30 - Design controls.
Subpart D--Document Controls
§ 820.40 - Document controls.
Subpart E--Purchasing Controls
§ 820.50 - Purchasing controls.
Subpart F--Identification and Traceability
§ 820.60 - Identification.
§ 820.65 - Traceability.
Subpart G--Production and Process Controls
§ 820.70 - Production and process controls.
§ 820.72 - Inspection, measuring, and test equipment.
§ 820.75 - Process validation.
Subpart H--Acceptance Activities
§ 820.80 - Receiving, in-process, and finished device acceptance.
§ 820.86 - Acceptance status.
Subpart I--Nonconforming Product
§ 820.90 - Nonconforming product.
Subpart J--Corrective and Preventive Action
§ 820.100 - Corrective and preventive action.
Subpart K--Labeling and Packaging Control
§ 820.120 - Device labeling.
§ 820.130 - Device packaging.
Subpart L--Handling, Storage, Distribution, and Installation
§ 820.140 - Handling.
§ 820.150 - Storage.
§ 820.160 - Distribution.
§ 820.170 - Installation.
Subpart M--Records
§ 820.180 - General requirements.
§ 820.181 - Device master record.
§ 820.184 - Device history record.
§ 820.186 - Quality system record.
§ 820.198 - Complaint files.
Subpart N--Servicing
§ 820.200 - Servicing.
Subpart O--Statistical Techniques
§ 820.250 - Statistical techniques.
因應歐盟2017年4月公告醫療器材新版法規，醫療器材製造廠之品質系統建置參考如下:
- MDR Regulation: REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices
- IVDR Regulation: Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
- Standard: ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.
- Guidance: PD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
何為PD CEN/TR 17223:2018?
本指引提供新版法規 (MDR 745/IVDR 746) 與 ISO 13485:2016 之間的對照
- 03.100.70 Management systems
- 11.040.01 Medical equipment in general
特別是MDR article 10 General obligations of manufacturers, Annex I General Safety and Performance Requirrments, Annex IX Conformity assessment bases on a quality manamgent syste and on assessmenet of Technical Documentation or Annex IX part A.
Health Canada 加拿大
進口醫療器材至加拿大前，製造廠應先取的MDSAP證書，以符合加拿大醫療器材品質系統要求。
Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars. The Medical Devices Regulations do not require importers or distributors of medical devices to have a registered quality system.The Medical Devices Regulations require class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485:2003. There are no regulatory quality system requirements for Class I medical devices. These quality system requirements came into force on January 1,2003.
Establishment Licences
- Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016) [2012-12-12]
- Medical Device Establishment Licence Application: Form and Instructions (FRM-0292) [2012-12-12]
Inspection Programme
- How Health Canada inspects medical device establishments (GUI-0064) [2016-11-17]
Guidance
- Medical devices recall guide (GUI-0054)
- Guidance on Investigation of Reported Medical Device Problems (GUI-0065)
- Guidance on Risk Classification of Medical Device Observations (GUI-0079)
- Mandatory Problem Reporting for Medical Devices
Recalls
- Recalls
- Health Products and Food Branch Inspectorate - Recall Policy (POL-0016)
- Product Recall Procedures
