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- CHỨNG NHẬN HACCP
◆ORIGO chứng nhận quốc tế ◆
◆Sanwei International
Certification Ltd◆
Email.:salestw.origo@gmail.com
Chất lượng dịch vụ : Chuyên nghiệp, công bằng và công chính
Thái độ làm việc.: chính trực, nghiêm ngặt, tận tình
Chỉ thị về thiết bị y tế Sửa đổi: Directive
2007/47 / EC
Các tài liệu liên quan:
(1) Directive 90/385 / EEC on the approximation of the laws of the Member
States relating to active implantable medical devices (AIMD) thiết bị y tế cấy
ghép chủ động, 2007
(2) Directive 93/42 / EEC concerning medical devices (MDD) Chỉ thị về thiết bị
y tế, 2007
(3) Directive 98/79 / EC on in vitro diagnostic medical devices (IVDD)
thiết bị y tế chẩn đoán in vitro, 2003
(4) COM (2005) 535 Implementing the Community Lisbon programme: A
strategy for the simplification of the regulatory environment.
Guidelines relating to medical devices Directives:
Các hướng dẫn liên quan đến các thiết bị y tế Chỉ thị:
2.1 Scope, field of application, definition Phạm vi, lĩnh vực áp dụng, định nghĩa.
MEDDEV 2.1/1Definitions of “medical devices”, “accessory” and “manufacturer”, April
1994
Định nghĩa về "thiết bị y tế", "phụ kiện" và "nhà sản
xuất", tháng 4 năm 1994
MEDDEV 2.1/2 rev.2 Field of application of directive “active implantable
medical devices”, February 1998
Lĩnh vực áp dụng chỉ thị "thiết bị y tế cấy ghép chủ động",
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
Các sản phẩm biên giới, sản phẩm thuốc và thiết bị y tế sáp nhập
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
Phân định ranh giới với các chỉ thị khác - Thiết bị y tế / chỉ thị liên quan đến
khả năng tương thích điện từ và thiết bị bảo vệ cá nhân
MEDDEV 2.1/5 Medical devices with a measuring function, June 1998
Thiết bị y tế có khả năng đo lường
MEDDEV 2.1/6 Qualification and Classification of stand alone software, January
2012
Yêu cầu về phần mềm
2.2 Các yêu cầu thiết yếu Essential requirements
MEDDEV 2.2/1 rev.1 EMC requirements, February 1998EMC Các yêu cầu về khả năng
tương thích điện từ EMC
MEDDEV 2.2/3 rev.3 “Use by”-date, June 1998 Kỳ hạn sử dụng
MEDDEV 2.2/4 Conformity assessment of In VitroFertilisation (IVF) and Assisted
Reproduction Technologies (ART) products, January 2012
2.4 Phân loại phân loại thiết bị y tế của MD Classification of MD
MEDDEV 2.4/1 rev.9 Classification of medical devices, June 2010
2.5 Thủ tục đánh giá sự phù hợp Conformity assessment procedure
General rule Quy tắc chung
Quality assurance. Regulatory auditing of quality systems of medical device
manufacturers
Bảo đảm chất lượng: Thẩm tra quản lý hệ thống chất lượng sản phẩm của nhà sản xuất thiết bị y tế.
MEDDEV 2.5/3 rev.2 Subcontracting quality systems related, June 1998 Hợp đồng thầu phụ liên quan đến hệ thống quản lý chất lượng.
MEDDEV 2.5/5 rev.3 Translation procedure, February 1998 Lưu trình phiên dịch
MEDDEV 2.5/6 rev.1 Homogenous batches (verification of manufacturers'
products), February 1998 Lô đồng chất lượng
Conformity assessment for particular groups of products Đánh giá thống nhất các loại sản phẩm cụ
thể
MEDDEV 2.5/7 rev.1 Conformity assessment of breast implants, July 1998 Đánh giá tính nhất quán của cấy ghép ngực
MEDDEV 2.5/9 rev.1 Evaluation of medical devices incorporating products
containing natural rubber latex, February 2004 Đánh giá thiết bị y tế với các sản phẩm hỗn hợp
MEDDEV 2.5/10 Guideline for Authorised Representatives, January 2012
2.7 Clinical investigation, clinical evaluation Điều tra lâm
sàng, đánh giá lâm sàng
MEDDEV 2.7/1 rev.3 Clinical evaluation: Guide for manufacturers and notified
bodies, December 2009
Appendix 1: Clinical evaluation on coronary stents, December 2008
Đánh giá lâm sàng: Hướng dẫn và phụ kiện cho các nhà
sản xuất và người chứng nhận
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 Chỉ thị nghiên cứu lâm
sàng: Hướng dẫn từ cơ quan có thẩm quyền.
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
Nghiên cứu lâm sàng: Báo cáo tác động bất lợi nghiêm
trọng
MEDDEV 2.7/4 Guidelines on Clinical investigations: a guide for manufacturers
and notified bodies, December 2010 Hướng dẫn nghiên
cứu lâm sàng: để hướng dẫn các nhà sản xuất và xác minh đơn vị
2.12 Nghiên cứu thị trường Market surveillance
MEDDEV 2.12/1 rev.8 Guidelines on a Medical Devices Vigilance System, January
2013 Hướng dẫn hệ thống cảnh báo thiết bị y tế
MEDDEV 2.12/2 rev.2 Post Market Clinical Follow-up studies, January 2012 Báo cáo theo dõi lâm sàng sau khi đưa lên thị trường.
2.13 Thời kỳ chuyển tiếp Transitional period
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
MEDDEV 2.14/1 rev.2 Borderline and Classification issues. A guide for
manufacturers and notified bodies, January 2012 Vấn đề biên giới
MEDDEV 2.14/2 rev.1 Research Use Only products, February 2004 Các sản phẩm nghiên cứu chuyên dụng.
MEDDEV 2.14/3 rev.1 Supply of Instructions For Use (IFU) and other information
for In-vitro Diagnostic (IVD)Medical Devices, January 2007 Hướng dẫn sử dụng và các thông tin liên quan đến thiết bị y tế IVD khác
Form for the registration of manufacturers and devices In Vitro Diagnostic
Medical DeviceDirective, Article 10, January 2007 IVD Cách thức đăng ký nhà sản xuất thiết bị y tế.
MEDDEV 2.14/4 CE marking of blood based in vitro diagnostic medical devices for
vCJD based on detection of abnormal PrP, January 2012
2.15 Other guidances Các hướng dẫn khác
MEDDEV 2.15 rev.3 Committees/Working Groups contributing to the implementation
of the Medical Device Directives, December 2008
-------------------------------------------------------------------
Medical Device Directive Revised: Directive
2007/47 / EC
Related documents:
(1) Directive 90/385 / EEC on the approximation of the laws of the Member
States relating to active implantable medical devices (AIMD) Active Implantable
Medical Devices, 2007
(2) Directive 93/42 / EEC concerning medical devices (MDD) Medical Device Directive,
2007
(3) Directive 98/79 / EC on in vitro diagnostic medical devices (IVDD) in vitro
diagnostic medical devices, 2003
(4) COM (2005) 535 Implementing the Community Lisbon program: A strategy for
the simplification of the regulatory environment.
Guidelines relating to medical devices Directives:
2.1 Scope, field of application, definition Scope, application area, definition
MEDDEV 2.1 / 1 Definitions of "medical devices",
"accessory" and "manufacturer", April 1994
"Medical equipment", "accessories" and
"manufacturer" definition
MEDDEV 2.1 / 2 rev.2 Field of application of directive "active implantable
medical devices", February 1998
"Active implantable medical device" indicates the field of
application
MEDDEV 2.1 / 3 rev.3 Borderline products, drug-delivery products and medical
devices incorporating, as integral part, an anillary medicinal substance or an
ancillary human blood derivative, December 2009
Border products, drug products and medical equipment merged
MEDDEV 2.1 / 4 Interface with other directives - Medical devices / directive
89/336 / EEC relating to electromagnetic compatibility and directive 89/686 /
EEC relating to personal protective equipment, March 1994
Demarcation with other directives - Medical devices / directives related to
electromagnetic compatibility and personal protective equipment
MEDDEV 2.1 / 5 Medical devices with a measuring function, June 1998
Medical equipment with measurement capabilities
MEDDEV 2.1 / 6 Qualification and Classification of stand alone software,
January 2012
Software requirements
2.2 Essential requirements Basic requirements
MEDDEV 2.2 / 1 rev.1 EMC requirements, February 1998 EMC electromagnetic
compatibility requirements
MEDDEV 2.2 / 3 rev.3 "Use by" -date, June 1998 Use Term
MEDDEV 2.2 / 4 Conformity assessment of In VitroFertilization (IVF) and
Assisted Reproduction Technologies (ART) products, January 2012
2.4 Classification of MD medical equipment classification
MEDDEV 2.4 / 1 rev.9 Classification of medical devices, June 2010
2.5 Conformity assessment procedure Conformity assessment procedure
General rule
Quality assurance. Regulatory auditing of quality systems of medical device
manufacturers
Quality Assurance: Quality System Management Review of Medical Device
Manufacturers
MEDDEV 2.5 / 3 rev.2 Subcontracting quality systems related, June 1998 Related
Subcontract Quality Systems
MEDDEV 2.5 / 5 rev.3 Translation procedure, February 1998 Translation process
MEDDEV 2.5 / 6 rev.1 Homogenous batches (verification of manufacturers'
products), February 1998 Same group
Consistent assessment of particular product categories
MEDDEV 2.5 / 7 rev.1 Conformity assessment of breast implants, July 1998
Breast Implant Consistency Assessment
MEDDEV 2.5 / 9 rev.1 Evaluation of medical devices incorporating products
containing natural rubber latex, February 2004 Evaluation of medical devices in
combination with animal-derived products
MEDDEV 2.5 / 10 Guideline for Authorized Representatives, January 2012
2.7 Clinical investigation, clinical evaluation Clinical research Clinical
evaluation
MEDDEV 2.7 / 1 rev.3 Clinical evaluation: Guide for manufacturers and
INFORMATION Bodies, December 2009
Appendix 1: Clinical evaluation on coronary stents, December 2008
Clinical Evaluation: Guidance and Accessories for
Manufacturers and Validators
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 Guidance Note for Clinical
Research: Guidance for Competent Authorities for making a validation /
assessment of a clinical investigation application under directives 90/385 /
EEC and 93/42 /
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
Clinical Study: Serious Adverse Events Report
MEDDEV 2.7 / 4 Guidelines on Clinical investigations: a guide for manufacturers
and inform bodies, December 2010 Guidance for Clinical Research: Guidance to
Manufacturers and Validators
2.12 Market surveillance market research
MEDDEV 2.12 / 1 rev.8 Guidelines on a Medical Devices Vigilance System, January
2013 Guide to Medical Device Alerting Systems
MEDDEV 2.12 / 2 rev.2 Post Market Clinical Follow-up studies, January 2012
Post-marketing Clinical Tracking Report
2.13 Transitional period Transitional period
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
MEDDEV 2.14 / 1 rev.2 Borderline and Classification issues. A guide for
manufacturers and notified bodies, January 2012 Boundary issues
MEDDEV 2.14 / 2 rev.1 Research Use Only products, February 2004
Research-specific products
MEDDEV 2.14 / 3 rev.1 Supply of Instructions For Use (IFU) and other
information for In-vitro Diagnostic (IVD) Medical Devices, January 2007 Use the
instructions provided with other IVD medical equipment related information
Form for the registration of manufacturers and devices In Vitro Diagnostic
Medical DeviceDirective, Article 10, January 2007 IVD Medical Device
Manufacturer Application Format
MEDDEV 2.14 / 4 CE marking of blood based in vitro diagnostic medical devices
for vCJD based on detection of abnormal PrP, January 2012
2.15 Other guidances Other guidelines
MEDDEV 2.15 rev.3 Committees / Working Groups contributing to the
implementation of the Medical Device Directives, December 2008
-------------------------------------------------------------------
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
(3) Directive 98/79/EC on in vitro diagnostic medical devices (IVDD)體外診斷醫療器材 , 2003
(4) COM(2005) 535 Implementing the Community Lisbon programme: A strategy for
the simplification of the regulatory environment.
Guidelines relating to medical devices Directives:
2.1 Scope, field of application, definition 範圍、申請領域、定義
MEDDEV 2.1/1Definitions of “medical devices”, “accessory” and “manufacturer”,
April 1994
“醫療器材”、”附件”及”製造商”定義
MEDDEV 2.1/2 rev.2 Field of application of directive “active implantable
medical devices”, February 1998
“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 stand alone software, January
2012
軟體需求
2.2 Essential requirements基本要求
MEDDEV 2.2/1 rev.1 EMC requirements, February 1998EMC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 VitroFertilisation (IVF) and Assisted
Reproduction Technologies (ART) products, January 2012
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
2.7 Clinical investigation, clinical evaluation臨床研究臨床評估
MEDDEV 2.7/1 rev.3 Clinical evaluation: Guide for manufacturers and notified
bodies, December 2009
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之導引
2.12 Market surveillance 市場調查
MEDDEV 2.12/1 rev.8 Guidelines on a Medical Devices Vigilance System, January
2013 醫療器材警覺系統導引
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 過渡時期
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
MEDDEV 2.14/1 rev.2 Borderline and Classification issues. A guide for
manufacturers and notified bodies, January 2012 邊界議題
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 使用指示提供以及其他IVD醫療器材相關資訊
Form for the registration of manufacturers and devices In Vitro Diagnostic
Medical DeviceDirective, Article 10, January 2007 IVD醫療器材的製造商申請格式
MEDDEV 2.14/4 CE marking of blood based in vitro diagnostic medical devices for
vCJD based on detection of abnormal PrP, January 2012
2.15 Other guidances 其他指引
MEDDEV 2.15 rev.3 Committees/Working Groups contributing to the implementation
of the Medical Device Directives, December 2008