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- Types of Updates: Determine the nature of the updates needed, which could include changes to device specifications, labeling, manufacturing processes, or indications for use.
- Adhere to Regulatory Requirements: Ensure ongoing compliance with all SFDA regulations and guidelines relevant to medical devices. This includes any updates or amendments to the regulations.
- Review SFDA Guidelines: Familiarize yourself with SFDA’s specific regulations and guidelines for Class D medical devices. This includes understanding the requirements for documentation, labeling, and compliance.
- Monitor Device Performance: Continuously track and assess the device's performance in the market. Ensure that it functions as intended and meets the safety and efficacy claims made during registration.
- General Description: Provide a detailed description of the device, including its intended use, design, components, and specifications.
- Documentation Preparation: Before submission, preparing and organizing the required documentation can take several weeks to months, depending on the complexity of the device and the availability of data.
- 2024-09-10Confirm Classification: Ensure that the device is correctly classified as Class D. Class D devices are considered high-risk and require extensive documentation and review.
- 2024-09-10Gather all required documents, including the technical file, clinical data, risk management report, proof of compliance with international standards, labeling, and instructions for use.
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