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Acceptance of New Applicants for the Technical Cooperation Program Hsiau-Wen Huang, Ph. D. Senior Acceptance of New Applicants for the Technical Cooperation Program Hsiau-Wen Huang, Ph. D. Senior Researcher Bureau of Pharmaceutical Affairs Department of Health

EU NB/DOH DAO Cooperation n Technical Cooperation Programme between EU NB and DOH designated EU NB/DOH DAO Cooperation n Technical Cooperation Programme between EU NB and DOH designated GMP auditing organizations (ITRI, MIRDC, ETC) sinc 2002 n Exchange of GMP/ISO 13485 audit report Ø 7. 16. 2004 (draft) Ø 11. 04. 2005 (official announcement) Ø TUVPS, NSAI, G-MED, MDC, BSI PS, TUV Rheinland Ø n Audit report can be used as part of the QSD requirement To eliminate duplicate inspection

Simplified Process for Quality System Document Requirements based on the Technical Cooperation Programme Effective Simplified Process for Quality System Document Requirements based on the Technical Cooperation Programme Effective Date Document No. 11. 04. 2005 Wei-Shu-Yao-Tze-0930328320 http: //www. doh. gov. tw/cht/list. aspx? dept=R&now_fod_list_no =4078&class_no=2&level_no=1&div. No=1&div. Count=5

1. 1. " Technical Cooperation Programme on Exchange of Medical Device GMP and ISO 13485 Audit Reports between DOH Designated Auditing Organizations and EU AIMD/MDD/IVD Notified Bodies“ signed by DOH DAO- ITRI, MIRDC and ETC and EU NB- TÜV Product Service, National Standards Authority of Ireland(NSAI), G-MED, Medical Device Certification (mdc), British Standards Institution Product Services and TÜV Rheinland Product Safety stated that each party will exchange the audit report of medical device to establish technical cooperation. Wei-Shu-Yao-Tze-0930328320

2. The documents required for DOH QSD approval of the medical devices manufacturers located 2. The documents required for DOH QSD approval of the medical devices manufacturers located in the European Union can be replaced by the audit report from above-mentioned six NB, ISO 13485 certificate, Free Sale Certificate issued from the highest regulatory authority while the EC/Chinese Taipei EOL and the EC NB/DOH DAO TCP are effective. Wei-Shu-Yao-Tze-0930328320

3. The medical device manufacturers located in Chinese Taipei can request to exempt from 3. The medical device manufacturers located in Chinese Taipei can request to exempt from duplicate inspection by using the audit report of DOH DAO while filing application for ISO 13485 certificate to the above-mentioned six NB. 4. The simplified process for QSD requirements will be under evaluation based on the influence of TCP. Wei-Shu-Yao-Tze-0930328320

Since the 11. 04. 2004 TCP Pilot Announcement……. . 40 QSD submissions with the Since the 11. 04. 2004 TCP Pilot Announcement……. . 40 QSD submissions with the simplified documents within 4 months The US EOL Impact…. . 107 QSD Approvals within 18 months

Announcement of Acceptance of Applications for Participation in the Announcement of Acceptance of Applications for Participation in the "Technical Cooperation Programme on Exchange of Medical Device GMP and ISO 13485 Audit Reports between DOH Designated Auditing Organizations and EU AIMD/MDD/IVD Notified Bodies" Wei-Shu-Yao-Tze-0940300678 January 27, 2005 http: //www. doh. gov. tw/EN/Webpa ge/index. aspx

Announcement 1. As per the public announcement Doc. No. Wei. Shu-Yao-Tze-0930328320 dated November 4, Announcement 1. As per the public announcement Doc. No. Wei. Shu-Yao-Tze-0930328320 dated November 4, 2004, it has been promulgated that three DOH Designated Auditing Organizations and six EU Notified Bodies signed the “Technical Cooperation Programme on Exchange of Medical Device GMP and ISO 13485 Audit Reports between DOH Designated Auditing Organizations and EU AIMD/MDD/IVD Notified Bodies”. Wei-Shu-Yao-Tze-0940300678

2. In order to further extend the cooperation mechanisms as prescribed in the exchange 2. In order to further extend the cooperation mechanisms as prescribed in the exchange of letters between EU and Chinese Taipei for the mutual exchange of information on medical devices, any EU Notified Body which has interest to establish technical cooperation and which complies with European Active Implantable Medical Devices Directive (AIMD) 90/385/EEC, Medical Device Directive (MDD) 93/42/EEC or In Vitro Diagnostics Directive (IVD) 98/79/EC, may between the date of this announcement and February 28, 2005, submit a letter of intent signed by its organization’s responsible person and send it to the Center for Measurement Standards of Industrial Technology Research Institute (CMS/ITRI) for participation in the Programme. Wei-Shu-Yao-Tze-0940300678

3. In addition, with regard to the current situation, this time the EU Notified 3. In addition, with regard to the current situation, this time the EU Notified Bodies applying for participation will be evaluated and the best ones chosen. The number of EU Notified Bodies that are to be the parties of the TCP will not be more than six. Wei-Shu-Yao-Tze-0940300678

4. Detail information regarding the Technical Cooperation Programme may be obtained by contacting directly 4. Detail information regarding the Technical Cooperation Programme may be obtained by contacting directly the Office of Medical Device Evaluation, CMS/ITRI (address: No. 321, Kuang-Fu Road, Section 2, Hsinchu City [e-mail: Mr. Albert Li at [email protected] org. tw]). Wei-Shu-Yao-Tze-0940300678

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