GPMDTechnicalFileMatrix(填写范例).docVIP

Company Name: ******Ltd.(公司名称英文) Job Number: C******(公司地址英文) MDD93/42/EEC Annex(s): AnnexⅡ.3(有无附录的特殊要求) Revision No.: A/0(可以不填写) Date of Issue: 2010-******(填表时间) Device Sub-Category [Class IIa]/ Generic Device Group [Class IIb] Technical File Name/Number Product Name Device Description Class GMDN Number Class IIb or NBOG Number Class IIa Medical Device Simple Complex Code Time Allocated (hours) Frequency Of Audit Year of Review [6 year cycle] Y1 Y2 Y3 Y4 Y5 Y6 Initial Subseq Yearly V1 V2 V3 V1 V2 V3 6 Monthly V1 V3 V5 V1 V3 V5 Section 1 – Class IIa I [sterile]; I [measuring] only TENS(产品名称英文) QRCE-TF-CSD(内部技术文档的编号) TENS: Neck electronic pulse massagers and Family Massager(产品英文名称;产品功能基本描述) Ⅱa(欧盟医疗器械等级) MD1103(全球医疗器械编码;可以在网站进行查询,也可以不用填写) 19E/ 311(SGS内部产品编码可以不填写) Y X Section 2 – Class IIb only Note: In “Year of Review” the following applies : X = Review Planned; Y = Review Completed. Justification for any changes in Sampling Regime documented above : Justification for Sampling Regime for each Device Sub-Category [Class IIa] Generic Device Group [Class IIb] : 1 File combined with two models to be review at V1/V1R. Record of Changes Date: Description of Change: Change to sampling Plan – Yes/No 29 Sept 2010 File name changed From KD-CETF001 to QRCE-TF-CSD No Approval of Plan: Signature Date: Technical File Matrix [*Note – Not including OBL] Job n°: CN/CAN 12171 Organization: Counter Scientific Development（GZ） Limited Location: Guangzhou, China Issue n° 1 Document