For Class C medical device registration with Singapore's Health Sciences Authority (HSA), a comprehensive set of technical documents is required to demonstrate the safety, efficacy, and quality of the device. Below are the key documents that must be included in the application:

Technical Document Requirements for Class C Medical Device Registration:

1. Device Description and Information:

   • Detailed Device Description: A comprehensive description of the device, including:
     • Intended use and indications for use.
     • Device classification (confirming Class C).
     • Components of the device and their functions.
     • Design specifications, including the materials, technology, and components used in the device.
     • Product family details, if applicable, in case of related devices with similar designs.

2. Clinical Evidence:

   • Clinical Evaluation Report (CER): A critical document for Class C devices, summarizing the clinical data that supports the device's safety and performance. This may include:
     • Clinical trial data (if available).
     • Clinical literature and post-market clinical data supporting the device's intended use.
     • Clinical equivalence data, if the device is similar to an already approved device.
     • The report should demonstrate how the device meets safety and performance standards.

3. Risk Management Documentation:

   • Risk Management Report based on ISO 14971: This document should describe:
     • The identification and assessment of potential risks associated with the device.
     • The risk control measures implemented to mitigate identified risks.
     • The risk management process should be in line with the ISO 14971 standard.

4. Quality Management System (QMS):

   • Proof of QMS compliance: The device must be manufactured under a Good Manufacturing Practice (GMP) framework, typically demonstrated by:
     • A valid ISO 13485 certification.
     • Documentation demonstrating compliance with QMS and GMP guidelines.
     • Evidence of internal audits, and the manufacturer’s processes for ensuring consistent product quality.

5. Performance and Testing Data:

   • Preclinical/bench testing data: This includes testing of the device’s functionality, durability, and performance in laboratory or simulated environments.
   • Biocompatibility testing results (for devices in contact with the body).
   • Electromagnetic Compatibility (EMC) testing data (for electronic devices).
   • Software validation, if the device includes software or is software-driven.
   • Sterility testing, if the device is supplied sterile.

6. Product Labeling and Instructions for Use (IFU):

   • Device labeling: Labels must comply with HSA’s requirements and should include:
     • Device name and manufacturer information.
     • Intended use, indications, contraindications, and any warnings or precautions.
     • Serial numbers, lot numbers, and expiry dates (if applicable).
   • Instructions for Use (IFU): Detailed instructions that include the correct use, handling, maintenance, and disposal of the device. It must be in English and follow HSA’s format guidelines.
   • Symbols on the device labeling that must adhere to the applicable standard.

7. Manufacturing Information:

   • Manufacturing process: Description of the manufacturing process, including materials, equipment, and controls used.
   • Facility information: Details of the manufacturing facility, including evidence of compliance with GMP.
   • Sterilization methods, if applicable, should be documented with supporting data.

8. Post-Market Surveillance (PMS) Plan:

   • A post-market surveillance plan is required to monitor the device’s performance once it is available on the market.
     • The plan should include mechanisms for reporting adverse events, field safety corrective actions, and recalls if necessary.

9. Declaration of Conformity (DoC):

   • A Declaration of Conformity from the manufacturer stating that the device meets all the relevant regulatory requirements and HSA standards.
   • This may also include conformity to ISO 13485, ISO 14971, and other relevant standards.

10. International Approvals (if applicable):

    • Provide copies of any international certifications or approvals (e.g., FDA approval, CE Marking, TGA approval) if the device is already marketed in other countries.
    • Foreign market approval documents help to demonstrate the device’s safety and efficacy in different regulatory regions.

11. Labeling and Packaging Specifications:

    • Packaging specifications for the device, including the materials and methods used.
    • Information on storage conditions and shelf-life, if applicable.

12. Technical File:

    • A comprehensive technical file that includes all the documents required for the registration process. This file should be kept up-to-date and made available for inspection by HSA.

Preparing the Application:

1. Collect all required documents: Ensure that all the documents listed above are complete and accurate.
2. Convert documents to electronic format (usually PDF) for submission through the HSA Medical Device Registration (MDR) Portal.
3. Review the application: Double-check the documentation for completeness before submission to ensure there are no missing or incorrect details.
4. Submit the application: Log into the MDR Portal and submit the application with all the required technical documents.
5. Respond to HSA’s requests: If HSA requests additional information or clarification, ensure prompt and complete responses.

By preparing these technical documents in line with HSA’s requirements, you help ensure the smooth approval process for Class C medical device registration in Singapore.

Let me know if you need further details or assistance with any specific document!