Documents Required for Class B Medical Device Registration with HSA in Singapore

When applying for Class B medical device registration with the Health Sciences Authority (HSA) in Singapore, you need to submit a comprehensive set of documents. These documents ensure that your device complies with Singapore's medical device regulations and meets safety and performance standards.

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

1. Product Registration Form

• Description: This is the online registration form that you will need to fill out via the Health Products Regulation System (HPRS) portal.
• Content: You will need to provide:
  • Device name and model.
  • Intended use or purpose of the device.
  • Manufacturer's details (company name, address, country).
  • Risk classification justification (confirming the device is Class B).
  • Product code and device type.
• Preparation: Log in to the HPRS portal, fill out the form, and upload the required documents.

2. Device Description

• Description: A detailed description of the medical device, including its:
  • Function and intended use.
  • Design, materials, components, and technology used.
  • Intended user (e.g., healthcare professionals, patients).
• Preparation: Prepare a clear, concise document that explains how the device works, its components, and its purpose. Include diagrams or pictures of the device if necessary.

3. Declaration of Conformity

• Description: A formal statement by the manufacturer declaring that the device complies with the relevant standards.
  • Example: A Declaration of Conformity stating that the device conforms to the Medical Device Directive (MDD) or Medical Device Regulation (MDR) (if the device is already CE-marked), or complies with ISO 13485 standards.
• Preparation: Prepare a signed statement from the manufacturer, ensuring that the device meets the required regulatory standards.

4. Conformity Assessment Documentation

• Description: Evidence that the device meets safety and performance standards.
  • For CE-marked devices: Provide a copy of the CE certificate and relevant documentation (including test reports, clinical data if applicable).
  • For FDA-approved devices: Provide FDA approval or clearance, if applicable.
• Preparation: If your device has been approved by other competent authorities (e.g., CE, FDA), include copies of the relevant certification documents. If the device has not been approved elsewhere, provide a comprehensive assessment of its conformity based on international standards.

5. Risk Management Report

• Description: A detailed risk management report that assesses all potential risks associated with the device and describes the mitigation measures taken.
  • Standard: This report must comply with ISO 14971 (the international standard for risk management of medical devices).
• Preparation: Include an analysis of the risks throughout the product lifecycle, from design and manufacturing to post-market surveillance. Document how risks are mitigated (e.g., design changes, safety warnings).

6. Clinical Evaluation Report (if applicable)

• Description: A report summarizing the clinical data, if applicable, demonstrating the device's safety and effectiveness.
  • Required for: Devices intended for clinical use, especially those that do not have substantial equivalent products on the market.
• Preparation: If your device requires clinical evaluation (e.g., a Class B device with clinical indications), include results of clinical trials or studies. If your device is substantially equivalent to a similar device already on the market, you can provide a clinical evaluation report showing equivalency.

7. Quality Management System (QMS) Certificate

• Description: A certificate confirming that the manufacturer has a Quality Management System (QMS) in place that complies with international standards, typically ISO 13485.
• Preparation: Obtain an official certificate from a recognized certification body. If the manufacturer has not been certified to ISO 13485, you may need to submit a self-declaration stating how the device meets quality standards or provide evidence of an alternative QMS.

8. Free Sale Certificate

• Description: A certificate from the regulatory authority in the country of origin confirming that the device is legally sold and distributed in that country.
• Preparation: Obtain the Free Sale Certificate from the regulatory body in the country where the device is marketed (e.g., the FDA in the U.S. or the European Medicines Agency for CE-marked devices).

9. Labeling and Instructions for Use (IFU)

• Description: The labeling for the device, including the Instructions for Use (IFU), must comply with HSA's requirements.
  • Labeling Requirements: The device label should contain essential information such as the device name, intended use, manufacturer information, country of origin, batch/serial numbers, warnings, and precautions.
  • IFU Requirements: The IFU should provide clear instructions on how to safely use the device.
• Preparation: Prepare the final label and IFU in the required format, ensuring compliance with the regulations specified by HSA.

10. Other Supporting Documents

• Depending on the type of device, additional supporting documents may be required. These might include:
  • Performance Testing Data (e.g., for in vitro diagnostic devices).
  • Biocompatibility Test Reports (for devices that come into contact with the body).
  • Sterilization Validation Reports (if the device is sterilized).

How to Prepare the Application

Step 1: Review HSA’s Regulatory Requirements

• Thoroughly review the HSA's Medical Device Registration Guidelines for Class B devices, available on the official HSA website.
• Ensure that all documents are prepared in accordance with HSA’s format and submission requirements.

Step 2: Appoint a Local Authorized Representative (LAR)

• If you are a foreign manufacturer, appoint an LAR registered with HSA. The LAR will submit the registration on your behalf.
• Work with the LAR to gather all necessary documents for submission.

Step 3: Complete the Online Application via HPRS

• Log into the Health Products Regulation System (HPRS) and start a new medical device registration application.
• Fill out the online registration form, providing all requested information about your device and manufacturer.

Step 4: Upload Required Documents

• Upload the prepared documents as required (e.g., device description, conformity assessment, risk management report, etc.).
• Ensure all documents are complete, accurate, and in English or accompanied by an English translation.

Step 5: Pay the Registration Fee

• Pay the registration fee via the HPRS portal. The fee for Class B devices is typically between SGD 1,000 to 2,000.

Step 6: Submit the Application

• After completing the form and uploading the documents, submit your application for HSA review.

Step 7: Await Evaluation and Approval

• HSA will evaluate the application, which can take 1 to 3 months. If further information is needed, they may contact you for clarification.
• Once approved, HSA will issue a Certificate of Registration for the device.

Key Considerations for Preparing the Application

• Completeness: Ensure all documents are complete, including any additional testing or data required by HSA.
• Accuracy: Double-check the accuracy of your device information, including intended use, manufacturer details, and labeling.
• Compliance: Ensure all documents comply with HSA’s specific formatting and regulatory requirements.
• Clinical Data: If your device requires clinical data, ensure that the clinical evaluation is thorough and provides sufficient evidence of safety and effectiveness.

By carefully preparing the necessary documents and following the steps outlined above, you can streamline the Class B medical device registration process with HSA in Singapore.

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