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2021-02-03

【医械体系质量宝】第17次更新，参考模板新增2个内容

2021-02-03

【医械体系质量宝】第19次更新，参考模板新增4个内容

2021-02-03

【医械体系质量宝】第18次更新，参考模板新增3个内容

2021-02-03

【医械体系质量宝】第22次更新，参考模板新增3个内容

2021-02-03

【医械体系质量宝】第21次更新，参考模板新增5个内容

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公告机构信息-MDR CE宝

2021-06-02 公告机构文件汇编.xlsx

138 33.27 KB

2021-06-02 MG 公告机构文件打包下载.rar

150 29.74 MB
2021-06-02 MG01.1 Questions for Quoting.doc

168 184.5 KB

2021-06-02 MG01.2 General terms and conditions of 3EC International a.s. (GTC).pdf

266 285.43 KB

2021-06-02 MG01.3 Pricelist for Conformity Assessment of MD.doc

140 95 KB

2021-06-02 MG01.4 Minimal Requirements for Content of the Technical Files of MD according to the MDR.pdf

245 50.43 KB

2021-06-02 MG01.5 Policy of CE marking use.doc

147 95 KB

2021-06-02 MG01.6 Flowchart of MD Conformity Assessment in NB2265..pdf

285 58.68 KB

2021-06-02 MG01.7 Notification of a Body in the framework of a technical harmonization directive.pdf

237 17.94 KB
2021-06-02 MG02.1 MDR Documentation Submissions.pdf

227 712.2 KB

2021-06-02 MG02.2 Notification of a Body in the framework of a technical（MDR）.pdf

226 19.98 KB

2021-06-02 MG02.3 MDR Conformity assessment routes.pdf

257 979.39 KB

2021-06-02 MG02.4 MDR certification process.pdf

231 79.96 KB

2021-06-02 MG02.5 Conformity assessment services and fees.pdf

218 133.46 KB

2021-06-02 MG02.6 Readiness review (MDR).docx

150 523.3 KB

2021-06-02 MG02.7 Mapping guide （MDR）.pdf

209 188.58 KB
2021-06-02 MG03.1 Notification of a Body in the framework of a technical harmonization directive.pdf

235 15.13 KB
2021-06-02 MG04.1 Notification of a body in the framework of a tecnical harmonization directive(MDR).pdf

222 11.59 KB
2021-06-02 MG05.1 Notification of a Body in the framework of a technical(MDR).pdf

227 23.59 KB
2021-06-02 MG06.1 Notification of a Body in the framework of a technical harmonization directive （MDR）.pdf

260 18.49 KB
2021-06-02 MG07.1 MDR_Evaluation Process.pdf

228 147.5 KB

2021-06-02 MG07.2 Notification of a Body in the framework of a technical(MDR).pdf

185 18.18 KB
2021-06-02 MG08.1 Certification process MDR.pdf

208 265.5 KB

2021-06-02 MG08.2 Overview over guidance documents and recommendations.pdf

225 103.49 KB

2021-06-02 MG08.3 Submission technical documentation under the MDR.docx

146 59.83 KB

2021-06-02 MG08.4 The starter kits information packages for a smooth application process under the MDR.pdf

278 70.21 KB

2021-06-02 MG08.5 Capacity Survey MDR Transistion.pdf

249 28.59 KB

2021-06-02 MG08.6 Technical Documentation.pdf

225 141 KB

2021-06-02 MG08.7 Overview over guidance documents and recommendations.pdf

227 150.85 KB

2021-06-02 MG08.8 DQS MED Terms and Conditions.pdf

270 91.07 KB

2021-06-02 MG08.9 Supplement General Business Conditions (MDSAP).pdf

296 138.08 KB

2021-06-02 MG08.10 Supplement General Business Conditions (MDR).pdf

252 68.79 KB

2021-06-02 MG08.11 Assessment and Certification Regulations.pdf

218 328.89 KB

2021-06-02 MG08.12 DQS MED Assessment and Certification Regulations.pdf

249 491.67 KB

2021-06-02 MG08.13 Rules for the use of the certificate symbols.pdf

209 263.32 KB

2021-06-02 MG08.14 Basic data MDSAP audited facility.docx

160 94.03 KB

2021-06-02 MG08.15 How to complete Basic date of MDSAP audited facility.docx

129 212.41 KB

2021-06-02 MG08.16 Basic data list MD ISO 13485 - Directive.xlsx

122 266.86 KB

2021-06-02 MG08.17 Basic data organization QM in Basic data ISO 9001 - 15378.docx

113 78.36 KB

2021-06-02 MG08.18 Basic data on the ISO 13485 - Directive.docx

116 78.62 KB

2021-06-02 MG08.19 Application for product certificationNotification of change.docx

119 77.73 KB

2021-06-02 MG08.20 Request for pre-assessment.docx

118 1.64 MB
2021-06-02 MG09.1 Declarations of interest of top-level management.pdf

205 782.23 KB

2021-06-02 MG09.2 Description of the application procedure by which manufacturers can obtain and maintain the certification.pdf

239 85.06 KB

2021-06-02 MG09.3 List of standard fees for the conformity assessment activities.pdf

192 169.4 KB

2021-06-02 MG09.4 Notification of a Body in the framework of a technical(MDR).pdf

198 13.88 KB
2021-06-02 MG10.1 Notification of a Body in the framework of a technical(MDR).pdf

192 21.26 KB
2021-06-02 MG11.1 evaluation procedures.pdf

190 1.2 MB

2021-06-02 MG11.2 MDR Information Form.docx

121 54.19 KB

2021-06-02 MG11.3 REGULATION FOR CONFORMITY.pdf

208 1.23 MB

2021-06-02 MG11.4 Notification of a Body in the framework of a technical(MDR).pdf

199 19.42 KB
2021-06-02 MG12.1 Notification of a Body in the framework of a technical(MDR).pdf

171 14.8 KB
2021-06-02 MG013.1 新MDR申请流程基本步骤.pdf

196 82.34 KB

2021-06-02 MG013.2 Notification of a Body in the framework of a technical(MDR).pdf

227 14.65 KB
2021-06-02 MG14.1 Notification of a Body in the framework of a technical(MDR).pdf

173 18.02 KB
2021-06-02 MG15.1 Designation Regulation (EU) 2017745 - MDR.pdf

197 272.15 KB

2021-06-02 MG15.2 Conformity Assessment Procedure Overview.jpg

113 88 KB

2021-06-02 MG15.3 Conformity Assessment Procedure Is and Im.pdf

215 43.44 KB

2021-06-02 MG15.4 Conformity Assessment Procedure III.jpg

102 64.58 KB

2021-06-02 MG15.5 Conformity Assessment Procedure IIb.pdf

175 35.07 KB

2021-06-02 MG15.6 Conformity Assessment Procedure IIa.pdf

215 42.97 KB

2021-06-02 MG15.7 Conformity Assessment Procedure Class I.pdf

204 38.16 KB

2021-06-02 MG15.8 List of EU-Representatives.pdf

186 65.99 KB

2021-06-02 MG15.9 List of Conformity Assessed Products and Critical Suppliers.xlsx

105 189.22 KB

2021-06-02 MG15.10 General Order and Payment Conditions.pdf

201 175.19 KB

2021-06-02 MG15.11 General Order and Payment Conditions-EN CN.pdf

202 468.96 KB

2021-06-02 MG15.12 Consultant Companies China.pdf

178 430.51 KB

2021-06-02 MG15.13 MDR Conformity Assessment Procedure Overview.pdf

210 65.85 KB

2021-06-02 MG15.14 MDR Conformity Assessment Procedure Class Is Ir Im.pdf

182 57.9 KB

2021-06-02 MG15.15 MDR Conformity Assessment Procedure Class III.pdf

211 66.35 KB

2021-06-02 MG15.16 MDR Conformity Assessment Procedure Class IIb.pdf

193 65.5 KB

2021-06-02 MG15.17 MDR Conformity Assessment Procedure Class IIa.pdf

224 64.31 KB

2021-06-02 MG15.18 MDR Conformity Assessment Procedure Class I.pdf

185 56.94 KB

2021-06-02 MG15.19 Preisliste Price list.pdf

207 179.45 KB

2021-06-02 MG15.20 MDR-Prices and Fees.pdf

223 126.12 KB
2021-06-02 MG16.1 CE Product Significant Change Notification and Review.docx

121 72.56 KB

2021-06-02 MG16.2 Class 1 Substantial Change Application.docx

129 103.27 KB

2021-06-02 MG16.3 Class IIa - IIb Non Implantable Substantial Change Application.docx

124 214.59 KB

2021-06-02 MG16.4 Class IIb Implantable, Class III, AIMD Substantial Change Application.docx

133 193.5 KB

2021-06-02 MG16.5 MDR 2017745 Class I S, M and RS.zip

104 133.29 KB

2021-06-02 MG16.6 MDR 2017745 Class IIa and IIb Non-Implantable.zip

119 265.3 KB

2021-06-02 MG16.7 Guidance Document - MDR Technical Documentation Checklist.pdf

203 193.61 KB

2021-06-02 MG16.8 Vigilance Reporting.docx

123 44.07 KB

2021-06-02 MG16.9 Post Market Surveillance Application.docx

103 156.91 KB

2021-06-02 MG16.10 Equivalence Route.docx

124 59.51 KB

2021-06-02 MG16.11 Quality Management System Substantial Change Application.doc

121 86.5 KB

2021-06-02 MG16.12 An overview of NSAI’s fees for conformity assessment activities under the MDR.pdf

181 211.06 KB

2021-06-02 MG16.13 NSAI and Enterprise Ireland Briefing on medical device regulation and brexit.pdf

184 3.49 MB

2021-06-02 MG16.14 ISO 13485 2016 NSAI Technical Questionnaire.pdf

241 222.7 KB

2021-06-02 MG16.15 Notification of a Body in the framework of a technical(MDR).pdf

183 15.31 KB
2021-06-02 MG17.1 Medical device questionnaire.pdf

199 452.45 KB

2021-06-02 MG17.2 Notification of a Body in the framework of a technical(MDR).pdf

173 12.9 KB
2021-06-02 MG18.1 Notification of a Body in the framework of a technical(MDR).pdf

187 20.93 KB
2021-06-02 MG19.1 Notification of a Body in the framework of a technical(MDR).pdf

217 23.13 KB
2021-06-02 MG20.1 MDR Conformity Assessment Charging Instruction.pdf

211 461.22 KB

2021-06-02 MG20.2 Notification of a Body in the framework of a technical(MDR).pdf

242 15.02 KB

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