弘亞生技顧問有限公司

馬來西亞 MDA

詳細內容: 分類：Guidance; 發佈於：2019-10-04, 週五 08:46; 作者 Super User; 點擊數：13461

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馬來西亞管理醫療器材的主管單位為衛生部(Ministry of Health Malaysia)轄下的醫療器材管理局（The Medical Device Authority, MDA）。2012年公告之醫療器材法案(Medical Device Act 2012 (Act 737) 是目前馬來西亞醫療器材管理依據。該法明確定義醫療器材與風險等級，並詳細規範醫療器材產品註冊、工廠管理與許可執照、以及第三方認證機構(Conformity assessment body, CAB)的角色與規範。

所規範者包含一般醫療器材與體外診斷醫療器材，依風險等級由低到高分為A、B、C、D。

一、Legislation

1. Medical Device Act 2012 (Act 737), 09/02/2012

2. Medical Device Regulations 2012 [P.U. (A) 500], 31/12/2012

二、Guidance Document

1. Definition of Medical Device, March 2014

2. Rules of Classification for General Medical Devices, March 2014

3. The Essential Principles of Safety and Performance of Medical Devices, March 2014

4. In-Vitro Diagnostic (IVD) Medical Device Classification System, July 2013

5. Conformity Assessment for Medical Device, October 2017

6. Essential Principles of Safety and Performance of IVD Medical Devices, July 2013

7. Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products, June 20^th 2019

8. Requirements for Labelling of Medical Devices, November 2018

9. Licensing for Establishment, May 2016

澳洲 TGA

詳細內容: 分類：Guidance; 發佈於：2014-04-12, 週六 17:41; 作者 Super User; 點擊數：18271

1. Australian Regulatory Guidelines for Medical Devices(ARGMD) (2011)

2. IVD guidance document

2.1 Application audit (technical file review) of IVD medical device applications (2011)

2.2 Conformity assessment overview (2011)

2.3 Business rules for reduced assessment fees for IVDS(2012)

2.4 Classification of IVD medical devices(2011)

2.5 Conformity assessment procedures ofr immunohaematology reagents(2012)

2.6 Fees and charges for IVD medical devices(2010)

2.7 Including IVD medical devices in the ARTG(2010)

2.8 Regulatory requirements for in-house IVDs in Australia(2012)

2.9 Software as in vitro diagnostic medical devices(IVDs)(2013)

2.10 The use of GMDN codes for IVD medical devices in Australia(2010)

2.11 What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs(2011)

2.12 What a sponsor needs to know about conformity assessment and manufacturer’s evidence for IVDs(2011)

3. Medical Device Standards Order

3.1 Medical device standards order( standards for biological safety of medical devices) 2008

3.2 Medical device standards order (standards for clinical evidence) 2008

3.3 Medical device standards order (standards for medical devices required to be sterile) 2008

3.4 Medical device standards order (standards for natural latex rubber condoms) 2008

3.5 Medical device standards order ( standards for risk management) 2008

4. Reduction of assessment fees for medical devices(2015)

5. Declaration of conformity templates(medical device) (2013)

6. Declaration of conformity templates (IVDs)

7. TGA labelling and packaging regulatory framework(2011)

8. Advertising therapeutic goods

9. Requirements for the assessment of medical devices containing animal material, with particular regard to the minimisation of risks relating to transmitting Transmissible Spongiform Encephalopathies (TSEs)

10. Essential principles check list (medical device)

11. Device-medicine boundary products (2005)

加拿大 CMDCAS

詳細內容: 分類：Guidance; 發佈於：2014-04-12, 週六 17:39; 作者 Super User; 點擊數：13380

1. Medical Devices Regulations(2015)

2. Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees(2013)

3. Fees for the Review of Medical Device Licence Applications(2013)

4. Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices(2013)

5. Medical device establishment licence application: form and instruction(FRM-0292)(2012)

6. How Health Canada inspects medical device establishments (2016)

7. Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs)(2012)

8. Policy on the Canadian medical devices conformity assessment system quality systems(2000)

9. ISO 13485 (2003) Quality Management System Audits Performed by Health Canada Recognized Registrars

10. Risk classification of GMP observations(2012)

11. Opportunity to be Heard in the Suspension of a Medical Device Licence(2011)

12. Guidance Document: Preparation of Summary Technical Documentation (STED)-based Class III and Class IV Premarket Medical Device Licence Applications, not including In Vitro Diagnostic Devices (IVDDs)(2011)

13. Guidance for the Interpretation of Significant Change of a Medical Device(2011)

14. Guidance Document: Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices(2011)

15. Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device(2011)

16. Guidance Document - How to Complete the Application for a New Medical Device Licence(2011)

17. Guidance Document - Private Label Medical Devices(2011)

18. Good Manufacturing Practices Guidelines(2009)

19. Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations(2006)

20. Cleaning validation guidelines(2008)

香港 MDCO

詳細內容: 分類：Guidance; 發佈於：2014-04-12, 週六 17:40; 作者 Super User; 點擊數：13055

一、醫療儀器行政管理制度有關指南

1. 醫療儀器行政管理制度中的定義及縮寫(GN-00)

2. 醫療儀器行政管理制度概覽(GN-01)

3. 按醫療儀器行政管理制度提交申請產品納入醫療儀器列表的補充(GN-01S)

4. 第II, III & IV 級醫療儀器表列指南(GN-02)

5. 本地負責人醫療事故呈報指南 (GN-03)

6. 認證評核架構及認證評核機構 (GN-04)

7. 體外診斷醫療儀器表列指南(GN-06)

8. 醫療儀器進口商表列事宜指南 (GN-07)

9. 本地製造商表列事宜指南 (GN-08)

10. 本地分銷商表列事宜指南(GN-09)

二、技術參考文件

1. 醫療儀器認證評核原則 (TR-001)

2. 證明符合醫療儀器安全及性能基本原則的技術文件摘要 (TR-002)

3. 醫療儀器分級規則(TR-003)

4. 醫療儀器安全及性能基本原則(TR-004)

5. 醫療儀器標籤附加規定(TR-005)

6. 體外診斷醫療儀器分級規則(TR-006)

三、守則

1. 本地負責人守則 (COP-01)

2. 認證評核機構守則 (COP-02)

3. 表列本地製造商守則 (COP-03)

4. 表列醫療儀器進口商守則 (COP-04)

四、其他補充

1. 醫療儀器分級網上系統 (20140515)

2. 如何申請表列體外診斷醫療儀器IVDMD

3. 如何申請表列第II/III/IV級醫療儀器

4. List of Recognised Standards for Medical Devices (RS-01)(20150609)

歐盟 CE

詳細內容: 分類：Guidance; 發佈於：2014-04-12, 週六 17:38; 作者 Super User; 點擊數：30717

醫療器材指令修訂版：Directive 2007/47/EC

相關文件：

(1) Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (AIMD) 主動植入式醫療器材, 2007

(2) Directive 93/42/EEC concerning medical devices (MDD)醫療器材指令, 2007

(1)&(2)已更新為Regulation (EU) 2017/745 Medical Devices Regulations, (MDR) 歐盟新醫療器材法規,2017，於2021年5月26日全面實施

(3) Directive 98/79/EC on in vitro diagnostic medical devices (IVDD)體外診斷醫療器材, 2003

(3)已更新為Regulation (EU) 2017/746 In Vitro Diagnostic Devices Regulations, (IVDR)歐盟體外診斷醫療器材法規,2017，預計於2022年5月26日全面實施

(4) COM(2005) 535 Implementing the Community Lisbon programme: A strategy for the simplification of the regulatory environment.

Guidelines relating to medical devices Directives 與醫療器材指令相關的指引：

2.1 Scope, field of application, definition 範圍、申請領域、定義

MEDDEV 2.1/1

Definitions of “medical devices”, “accessory” and “manufacturer”, April 1994

“醫療器材”、“附件”及“製造商”的定義

MEDDEV 2.1/2 rev.2

Field of application of directive “active implantable medical devices”, April 1994

“主動植入式醫療器材”指示申請領域

MEDDEV 2.1/3 rev.3

Borderline products, drug-delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative, December 2009

邊界產品、傳遞藥物產品及醫療器材的合併物

MEDDEV 2.1/4

Interface with other directives – Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective equipment, March 1994

與其他指令分界-與電磁相容性相關之醫療器材/指令以及個人防護設備相關

MEDDEV 2.1/5

Medical devices with a measuring function, June 1998

有測量功能之醫療器材

MEDDEV 2.1/6

Qualification and Classification of standalone software, July 2016

軟體需求

2.2 Essential requirements 基本要求

MEDDEV 2.2/1 rev.1

EMC requirements, February 1998

EMC電磁相容性要求

MEDDEV 2.2/3 rev.3

“Use by”-date, June 1998

使用期限

MEDDEV 2.2/4

Conformity assessment of In Vitro Fertilization (IVF) and Assisted Reproduction Technologies (ART) products, January 2012

體外受精(IVF)與輔助生殖技術(ART)產品的一致性評估

2.4 Classification of MD 醫療器材分類

MEDDEV 2.4/1 rev.9

Classification of medical devices, June 2010

2.5 Conformity assessment procedure 一致性評估程序

•General rule 基本規範

Quality assurance. Regulatory auditing of quality systems of medical device manufacturers

品質保證：醫療器材製造商之品質系統管理審查

MEDDEV 2.5/3 rev.2

Subcontracting quality systems related, June 1998

相關之轉包契約品質系統

MEDDEV 2.5/5 rev.3

Translation procedure, February 1998

翻譯流程

MEDDEV 2.5/6 rev.1

Homogenous batches (verification of manufacturers' products), February 1998

同質批組

•Conformity assessment for particular groups of products 特殊產品類別的一致性評估

MEDDEV 2.5/7 rev.1

Conformity assessment of breast implants, July 1998

乳房植入物一致性評估

MEDDEV 2.5/9 rev.1

Evaluation of medical devices incorporating products containing natural rubber latex, February 2004

與取自動物之混合產品醫療器材評估

MEDDEV 2.5/10

Guideline for Authorised Representatives, January 2012

授權代表指引

2.7 Clinical investigation, clinical evaluation 臨床研究臨床評估

MEDDEV 2.7/1 rev. 4

Clinical evaluation: Guide for manufacturers and notified bodies, June 2016

Appendix 1: Clinical evaluation on coronary stents, December 2008

臨床評估：給製造商與驗證單位之導引與附件

MEDDEV 2.7/2 rev. 2

Guidelines for Competent Authorities for making a validation/assessment of a clinical investigation application under directives 90/385/EEC and 93/42/EC, September 2015

臨床研究指示：給合格當權者之導引

MEDDEV 2.7/3 rev. 3

Clinical investigations: serious adverse reporting under directives 90/385/EEC and 93/42/EC - SAE reporting form, May 2015

臨床研究：嚴重不利事件報告

MEDDEV 2.7/4

Guidelines on Clinical investigations: a guide for manufacturers and notified bodies, December 2010

臨床研究導引：給製造商與驗證單位的指引

2.12 Post-Market surveillance 上市後監督

MEDDEV 2.12/1 rev.8

Guidelines on a Medical Devices Vigilance System, January 2013

Additional guidance on MEDDEV 2.12/1 rev.8,July 2019

醫療器材警戒系統指引

MEDDEV 2.12/2 rev.2

Post Market Clinical Follow-up studies, January 2012

上市後臨床追蹤報告

2.13 Transitional period 過渡期

MEDDEV 2.13 rev.1

Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05), August 1998

As regards the transitional regime of Directive 2007/47/EC see the Interpretative Document of the Commission's services of 5 June 2009

2.14 IVD 體外診斷醫療器材

MEDDEV 2.14/1 rev.2

Borderline and Classification issues. A guide for manufacturers and notified bodies, January 2012

界定與分級議題：給製造商與驗證單位的指引

MEDDEV 2.14/2 rev.1

Research Use Only products, February 2004

研究專用之產品

MEDDEV 2.14/3 rev.1

Supply of instructions for use (IFU) and other information for in-vitro diagnostic (IVD) medical devices, January 2007

提供使用說明以及其他體外診斷醫療器材的資訊

Form for the registration of manufacturers and devices In Vitro Diagnostic Medical DeviceDirective, Article 10, January 2007