Technical Assistance Services for NMPA Registration of Medical Devices in China
分类:公司新闻 发布时间:2024-08-29 17:23:31
These services streamline the registration process and ensure compliance with NMPA requirements.

Technical assistance services for NMPA registration include:

  1. Regulatory Consultancy: Experts guide you through the regulatory requirements, help classify your device, and prepare the necessary documentation.

  2. Clinical Trial Support: Services assist with planning, executing, and managing clinical trials, including finding local clinical sites and coordinating data collection.

  3. Quality Management System (QMS) Implementation: Consultants help establish or enhance your QMS to comply with ISO 13485 or NMPA-specific standards.

  4. Documentation Preparation: Professionals assist in compiling and translating technical documentation, including user manuals, safety reports, and performance data.

  5. On-Site Inspections: Assistance with preparing for and managing NMPA inspections of manufacturing facilities.

  6. Registration Submission: Services include the preparation and submission of registration applications, handling interactions with NMPA, and responding to queries or requests for additional information.

These services streamline the registration process and ensure compliance with NMPA requirements.

Contact Us:

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

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