Documents Needed for A-Class Medical Device Registration with Singapore HSA

When applying for A-class medical device registration with the Health Sciences Authority (HSA) in Singapore, you must submit various documents through the Regulatory Information Management System (RIMS). These documents demonstrate that the device meets HSA's safety and performance requirements.

Below is a list of the required documents and guidance on how to prepare them:

1. Device Description

• What to include: A detailed description of the device, including:

  • Name of the device.
  • Intended use: What medical condition or purpose the device is meant to address.
  • Design and Function: Basic design, materials, and how the device works.
  • Target users: Who will use the device (e.g., healthcare professionals, patients).
  • Product Codes: If applicable, the product classification or codes under regulatory frameworks (e.g., CPT codes, UDI, etc.).

• How to prepare:

  • Create a clear, concise description that includes essential details about the device's construction, intended purpose, and usage instructions.
  • Make sure the description aligns with the claims made in the device’s labeling.

2. Labeling and Instructions for Use (IFU)

• What to include:

  • Labels: The device labeling must be in accordance with HSA's requirements. Labels should include:
    • Name of the device.
    • Manufacturer details (name and address).
    • Intended use.
    • Any necessary warnings, precautions, and contraindications.
  • Instructions for Use (IFU): A detailed guide on how to use the device safely. This should include:
    • Overview of the device.
    • Step-by-step instructions.
    • Warnings and contraindications.
    • Storage, handling, and disposal instructions.
    • Potential adverse events or side effects.

• How to prepare:

  • Ensure that both labeling and IFU are clear, comprehensive, and easy to understand.
  • If the device is for consumer use, ensure the language is simple and non-technical. If it’s for healthcare professionals, the instructions can be more technical.
  • Verify that your labeling complies with HSA's regulations and guidelines.

3. Risk Management and Safety Information

• What to include:
  • Risk Assessment Report: A comprehensive analysis of any potential risks associated with the device (e.g., electrical hazards, risk of infection). This should include:
    • Identification of hazards.
    • Risk mitigation strategies (design features, warnings, user instructions).
    • Evaluation of residual risks.
  • Risk Management File: A file that contains all relevant risk assessments, hazard analysis, and risk control measures.
• How to prepare:
  • Prepare a risk management report based on recognized standards (e.g., ISO 14971 - Medical Devices: Application of Risk Management).
  • Ensure that all identified risks are addressed with appropriate mitigation measures.

4. Conformity Assessment Documentation

• What to include:
  • Declaration of Conformity: A statement from the manufacturer affirming that the device complies with all relevant regulatory requirements, such as:
    • ISO standards (e.g., ISO 13485 for quality management systems).
    • Good manufacturing practices (GMP).
  • ISO 13485 Certificate (if applicable): Certification showing the manufacturer’s compliance with quality management standards.
• How to prepare:
  • If the device complies with international standards (e.g., CE Mark, FDA clearance), provide relevant certificates.
  • If the device is manufactured according to ISO 13485, provide a copy of the certification from an accredited body.

5. Manufacturer Information

• What to include:
  • Manufacturer’s name.
  • Address and contact details.
  • Manufacturing site details (if applicable).
• How to prepare:
  • Ensure that all manufacturer details are clearly documented and match the information on your device's labeling and IFU.

6. Clinical Data (If Applicable)

• What to include: Clinical evidence, if applicable, based on the intended use and risk classification of the device. For A-class devices, clinical data is not usually required unless the device makes medical claims that necessitate clinical validation.

  • Clinical trials: If clinical trials were conducted, provide summary reports or references to clinical evidence.
  • Literature Review: If the device does not have clinical trial data, you may submit a clinical literature review or data from similar devices.

• How to prepare:

  • If clinical data is needed, provide a concise summary of the study design, results, and conclusions.
  • If clinical data is not required, you may submit a justification statement explaining why clinical evidence is not needed.

7. Other Supporting Documents (If Applicable)

• What to include:
  • Certificates of Compliance: If the device has been certified or cleared by other regulatory authorities (e.g., CE Mark, FDA clearance, or Health Canada), include these certificates.
  • Environmental Considerations: If relevant, provide any environmental or biocompatibility testing reports (e.g., ISO 10993 for biological evaluation of medical devices).
  • Manufacturing Site Inspection Reports: If relevant, provide inspection reports from third-party auditors or regulatory bodies that have inspected the manufacturing facility.
• How to prepare:
  • Ensure that all supplementary documents are in English or officially translated into English.
  • Provide any necessary explanations about the documents, especially if the document is specific to another market.

8. Application Form

• What to include:

  • Complete the online application form on the RIMS Portal. This form will ask for basic details about the manufacturer, device classification, and regulatory history of the device.

• How to prepare:

  • Double-check the form for accuracy before submission. Ensure all fields are filled in correctly and that no information is omitted.

How to Prepare the Application Files

1. Organize Your Documents:

   • Keep your files organized and ensure they are clearly labeled for easy reference. Use folders or sections that align with the document categories listed above.
   • Create a cover letter if needed, explaining the purpose of the application and any special considerations.

2. Format the Files:

   • Convert documents into PDF format where possible. This is the standard file format accepted by HSA and ensures your documents are easily readable.
   • Ensure that the document size is within the HSA’s file upload limits (usually 20 MB per file).

3. Translation (If Applicable):

   • If any documents are in a language other than English, ensure they are accurately translated into English. Official translations are preferred to ensure clarity and accuracy.

4. Compliance Check:

   • Before submitting, conduct a thorough compliance check to ensure all required documents are included and comply with HSA’s guidelines.
   • If you are unsure about any aspect, it’s a good idea to consult with an expert or a regulatory consultant familiar with the HSA process.

5. Submission via RIMS Portal:

   • Log into the RIMS Portal and submit the documents electronically.
   • Follow the submission guidelines in the portal carefully, ensuring each document is attached to the correct section of the application.

Precautions When Preparing the Application

1. Verify Document Completeness: Ensure that all required documents are complete and that no sections are left incomplete or missing.
2. Accuracy: Double-check all device details, labeling, and manufacturer information for accuracy to prevent delays or rejections.
3. Clear Language: Use clear, simple, and precise language in all documents, especially in labeling and Instructions for Use (IFU).
4. Ensure Compliance with HSA Standards: Make sure that your labeling, instructions, and technical documentation meet HSA’s regulatory standards and guidelines.
5. Prepare for Follow-up: Be prepared to provide additional information or clarification if HSA requests further documentation during their review process.

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