五月天堂婷婷爱,色狠狠天天综合色香阁,91免费看国产,久久久久成人精品亚洲国产av综合,91啦在线播放,免费a一级毛片在线播放,天天日日夜夜看综合网,亚洲成人国产精品,奇米影视7777狠狠狠狠色,日韩精品高清在线观看,福利久久久,久久99国产精品片久久99蜜桃,91香蕉视频网址,婷婷91,久久久久久臀欲欧美日韩,少妇丰满大乳被男人揉捏视频

review standard for NMPA certified medical devices
Category：企業(yè)動態(tài) Date：2024-07-22 16:20:38 Author: Source:
These documents are crucial for demonstrating compliance with NMPA regulations and ensuring a smooth certification process in China.

The essential document for applying for NMPA certification (formerly known as CFDA certification) in China typically includes:

  1. Technical Documentation: This includes detailed information about the design, manufacturing process, materials used, and performance characteristics of the medical device.

  2. Clinical Evaluation Report: Depending on the risk classification of the device, clinical data and evaluation reports demonstrating safety and efficacy may be required.

  3. Quality Management System (QMS) Documentation: Evidence of compliance with ISO 13485 or equivalent quality management standards.

  4. Device Testing Reports: Testing reports from accredited laboratories demonstrating compliance with relevant standards, such as GB standards for medical devices.

  5. Labeling and Instructions for Use (IFU): Comprehensive labeling information in Chinese and IFUs that are clear and compliant with local regulations.

  6. Manufacturing License: For manufacturers outside China, a copy of the Manufacturing License issued by the regulatory authority in the country of origin may be required.

  7. Authorized Representative Documents: If applicable, documents appointing an authorized representative in China.

These documents are crucial for demonstrating compliance with NMPA regulations and ensuring a smooth certification process in China.


Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn


1 - 副本.jpg