cma检验报告模板
中国医疗器械行业协会（简称“cma”）于2011年2月22日在北京召开年会，会议通过了《中国医疗器械行业检验检测报告模板》（以下简称“模板”），该模板由cma医疗器械分会检验检测工作委员会编制。
为了使医疗器械行业的检验检测报告更加标准化、规范化，适应临床应用需求，cma制定了这一具体操作规程。使用过程中如有任何疑问，可以咨询cma医疗器械分会（联系人：王剑波；电话：；传真：；e-mail：medtech@cmanet.org）。
一、报告模板编制原则
（一）参照国家相关法律法规和标准，结合行业实际，制定符合我国国情的报告模板；
（二）模板包括产品名称、型号、生产厂家、检验项目和检验结论等内容；
（三）模板具有较强的可读性和可操作性；
（四）模板可供医疗器械企业和检验检测机构使用。
二、报告模板适用范围
（一）适用于医疗器械企业自检和外委检验检测报告；
（二）适用于cma认可的检验检测机构的医疗器械检验检测报告。
三、使用方法
（一）医疗器械企业应当按照模板的要求，填写检验检测报告；
（二）检验检测报告必须由检验人员签字确认，并盖上检验检测机构；
（三）检验检测报告应当附有检验方法、检验设备、检验条件和检验结论说明。
四、报告模板内容
（一）产品名称、型号、生产厂家（企业名称）：
（二）检验项目（请按照下表填写检验项目）：
表 1 检验项目
项目 序号 项目名称 检验方法 检验要求
（三）检验结论：
（四）检验人员签字：
（五）检验日期：
年 月 日
（六）检验检测机构：
（七）备注（包括但不限于检验方法、检验设备和检验条件等）：
cma testing & reporting template
the china medical device industry association (cma) held its annual conference in beijing on february 22, 2011, at which the “china medical device industry testing & reporting template” (hereinafter referred to as the “template”) was adopted. the template was formulated by the testing & inspection working committee of cma medical device branch.
in order to standardize and regularize testing and inspection reports in the medical device industry and to meet clinical application needs, cma has developed this specific set of operating procedures. if you have any questions during use, please contact cma medical device branch (contact person: wang jianbo; phone: ; fax: ; e-mail: medtech@cmanet.org).
i. principles for the formulation of the template
(1) based on relevant national laws and regulations and industry practices, formulate a report template that is suitable for china’s national conditions;
(2) the template includes product name, model, manufacturer, test items and test results, etc.;
(3) the template is highly readable and operable;
(4) the template can be used by medical device enterprises and testing & inspection organizations.
ii. the scope of application of the template
(1) the template is applicable to self-testing and outsourced testing & inspection reports of medical device enterprises;
(2) the template can be used in medical device testing & inspection reports of cma-accredited testing & inspection organizations.
iii. how to use
(1) medical device enterprises should fill out testing & inspection reports in accordance with the requirements of the template;
(2) the testing & inspection report must be signed and confirmed by the tester and stamped with the official seal of the testing & inspection organization;
(3) the testing & inspection report should be accompanied by a deion of the test method, test equipment, test conditions and test results.
iv. the content of the template
(1) product name, model and manufacturer (enterprise name):
(2) test items (please fill in the test items according to the following table):
table 1 test items
test item no. test item name test method test requirements
(3) test results:
(4) signature of testers:
(5)
