1、 程序文件 第 1 页 共 25 页警戒系统控制程序 文件编号： QP-28版本：A/0 生效日期： 页码： 25编制： 审核： 批准：1. 目的遵照 MDD (93/42/EEC DirCEtion 1 Place Fontenoy 33/1/40/564436 33/1/405649Mr.J.Grisoni des Hopitaux(site materiovigilance:www.sante.gouv.fr)F-75370 Paris 07SPGERMANY Bundesinstitut fur Arzneimittel und Seestr,10-11 D-13353 Berlin
2、49/30/45485384 49/30/75530Herrn StoBlein Medizin-produkle;Geschaftsstelle Medizin-produkleGRECEE Ministry of Health, 17 Aristoteleous Street 30/1/5232821 30/1/5233214Welfare and Social Services GR-101-87 AthensMr.E.Papadeas Biomedical TCEhnology DepartmentIRELAND Department of Health Haw kins Huse;I
3、RL-Dublin 2 353/1/6714711 353/1/671192Mr.B.lngoldsbyICELAND Ministry of Health Haw gavegur 116 IS-150 35/45/609700 35/45/51965Mrs.Haraldsdottir and Social Service TeykjiavikITALY Dottissa Minstry of Health P.le lndustria 20;1-0144 ROMA 39/6/59942423 39/6/5994211M.Marletta Department LUXEMBOURG Divis
4、ion de la Medcine Curative 4 rue Auguste Lumiere 352/4785633 352/460/324Dr.Gerard Scharll Social L-1950 Luxembourg /(4785634)NETHERLANDS Staatstoezicht op de Volksgezondheid, PO Box 5850 NL-2280HW Rijsw ijk 31/70/3406241 31/70/340715程序文件 第 9 页 共 25 页P.A.Loekemeijer lnspCEtie voor de GezondheidszorgN
5、ORWAY National Board Health (Email:ingeborg. PO Box 8128 Dep.N-032 Olso 47/22/248953 47/22/249017Mrs.Hagerup-Jenssen hagerup- jessenhelsetilsynet.dep.telemax.no)(w ebsite:www.helsetilsynet.no) 47/22/248940PORTUGAL INFARMED Parque Saude de Lisboa 351/1/7908500 351/1/7959116a)non-active devices:Mrs.AB
6、REUAv.Do Brasil,53 P-1700 Lisboab)active devices:Mrs.Faria gomesINSA Av.Padre Cruz P-1699 Lisboa Codex351/1/7573557 351/1/7573671SPAIN Minidteril de sanidady Consumo Paseo del Prado 18/20 34/1/5964022 34/1/5964400Carmen Abad Luna DirCEcion General de Farmaciay Productos SanitatiosE-28071 MadridSWEDE
7、N National Board of Health and Welfare, S-10630 Stockholm 46/8/7833499 46/8/7833294Bo C.Hojdefors Medical DevicesCOUNIRIES/NAMES COMPANIES ADDRESSED PHONE FAXSWITZERLAND Office federal de la CH-3003 Bern 41/31/3229803 41/31/3227640Dr.Peter Frei Sante PubliqueUNITED KINDGOOD Aderse lncident Center,De
8、partment Hannibal House,Eleph- 44/171/4928080 44/171/9278109RonDale of Health Room ant and Castle,UK-LondonCOMMISSION DG,lll.D2 (Medical devices 200,rue de la Loi; 32/2/2959339 32/2/2967013CONTACT sCEtor, SC 15 3/133) B-1049 Brussels 32/2/2959154Norbert Anselmann SCEretaria)程序文件 第 10 页 共 25 页附三：Manu
9、facturers Incident ReportMedical Devices Vigilance System(MEDDEV 2.12/1 rev 8)1. Administrative informationRecipientName of National Competent Authority (NCA)Address of National Competent AuthorityStamp box for the CompetentAuthority ( 60 x 40 mm)Date of this reportReference number assigned by the m
10、anufacturerReference number assigned by NCAType of reportInitial reportFollow-up reportCombined Initial and final reportFinal reportDoes the incident represent a serious public health threat?YesNoClassification of incidentDeathUnanticipated serious deterioration in state of healthAll other reportable incidentsIdentify to what other NCAs this report was also sent2. Information on submitter of the report
