.png)
.jpg)
Your current location: News
search
- ISO 13485:2016: This is the standard for quality management systems (QMS) specific to medical devices. It outlines requirements for a comprehensive quality management system for the design, manufacturing, and distribution of medical devices.
- Device Name and Classification: The name of the device and its classification according to SFDA guidelines.
- Preparation Time: Gathering and preparing the required documentation, including technical files, clinical data, and risk management, can take 1 to 3 months depending on the complexity of the device and the availability of data.
- 2024-09-09Non-Saudi manufacturers must have a Saudi-based Authorized Representative (AR) who is licensed by the SFDA. The AR will handle the registration process and ensure compliance with SFDA regulations.
- 2024-09-09Non-Saudi manufacturers must appoint a Saudi-based Authorized Representative (AR) who holds a valid SFDA Medical Device Establishment License (MDEL).
- Non-Saudi manufacturers must appoint a Saudi-based Authorized Representative (AR) who holds an SFDA Medical Device Establishment License (MDEL).
- Non-Saudi manufacturers must appoint a Saudi-based Authorized Representative (AR), who is licensed by the SFDA. This AR will handle the submission process on your behalf.
- The SFDA charges fees for processing the registration of a medical device. For Class C devices, the fees typically range between $4,000 to $6,000 USD.
.png)
Whatsapp or Wechat：+86 15816864648
Email address：hito.lin@grzan.cn
Add: Room 103-108, Building B, Block 2, Bangkai Science and Industrial Park, NO.9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
Copyright © Guangdong Grzan Group Co.,LTD. All rights reserved 京CP备1234567890号-4
.png)