When applying for Class B medical device registration with the Health Sciences Authority (HSA) in Singapore, there are several technical document requirements that must be submitted to demonstrate the safety, efficacy, and quality of the device. These documents help HSA evaluate the device and ensure it meets regulatory standards.

1. Product Registration Form

• Online Form: Submit the product registration form via the Health Products Regulation System (HPRS) portal. This form requires basic details about the device, such as:
  • Device name and description.
  • Manufacturer’s name and address.
  • Intended use and indications.
  • Classification and justification.
  • Risk classification (justification for Class B).
  • Device’s conformity status (e.g., CE marking, FDA approval).

2. Device Description

• Comprehensive Description: Provide a detailed description of the device, including:
  • The design and functional characteristics of the device.
  • Materials used in the device (e.g., biocompatibility).
  • Intended purpose and target patient population.
  • Device classification justification.
• For example, if it is a diagnostic device, the description should detail how it functions, what parameters it measures, and how the test results are used in clinical practice.

3. Declaration of Conformity

• Regulatory Compliance Declaration: Submit a Declaration of Conformity (DoC) confirming that the device complies with relevant international regulations or standards. For example:
  • CE marking for devices marketed in the EU.
  • FDA approval for devices cleared in the United States.
  • If not CE-marked or FDA-approved, provide other evidence of compliance with applicable regulations (e.g., ISO standards).

4. Risk Management Report

• ISO 14971 Compliance: Submit a Risk Management Report that details how risks associated with the device are identified, assessed, and mitigated. The report should follow ISO 14971, which is the international standard for medical device risk management.
  • This includes an assessment of potential hazards, evaluation of risks (severity and probability), and the methods used to control risks (design controls, testing, etc.).

5. Clinical Evaluation Report (If Applicable)

• Clinical Data: Submit a Clinical Evaluation Report if the device requires clinical data to demonstrate safety and performance. The report should:
  • Summarize clinical studies or trials (if available).
  • Include clinical evidence from literature, if direct clinical trials are not available.
  • Justify the device’s safety and performance based on available data.
• This is required if the device has a clinical application or if it is a novel device without existing clinical data from other jurisdictions.

6. Quality Management System (QMS) Certification

• ISO 13485 Compliance: Submit a valid ISO 13485 certificate (or equivalent) that confirms the manufacturer has a quality management system (QMS) in place. The QMS must cover all aspects of the device’s lifecycle, including:
  • Design and development.
  • Manufacturing.
  • Post-market surveillance.
  • Corrective and preventive actions (CAPA).
• If the manufacturer is not ISO 13485-certified, HSA may request an assessment of the manufacturer’s quality processes.

7. Labeling and Instructions for Use (IFU)

• Device Labeling: Submit the labeling for the device, which must include:

  • Product name and description.
  • Manufacturer and distributor details.
  • Device model or serial number.
  • Batch or lot number (if applicable).
  • Expiry date (if applicable).
  • Country of origin.

• Instructions for Use (IFU): Provide clear IFU, which should include:

  • Instructions on how to use the device safely and effectively.
  • Warnings and contraindications.
  • Maintenance and cleaning instructions (if applicable).
  • Disposal instructions (if applicable).

• Labeling Requirements: Ensure compliance with ISO 15223 for medical device labeling, including symbols and text that meet international standards.

8. Sterilization and Biocompatibility Documentation (If Applicable)

• Sterilization Validation: If the device is sterilized, provide validation data showing that the sterilization process used (e.g., ethylene oxide, gamma radiation) is effective and consistent.

• Biocompatibility Data: If the device comes into contact with the human body, provide biocompatibility testing results to ensure the materials used are safe. This includes compliance with ISO 10993 for biocompatibility testing, which covers cytotoxicity, sensitization, and irritation.

9. Performance Testing Data (If Applicable)

• Performance Data: If the device is diagnostic or performance-sensitive (e.g., an in vitro diagnostic device), provide performance testing data to demonstrate that it meets the specified performance criteria (e.g., accuracy, precision, sensitivity, specificity).
  • This may include clinical trials, laboratory tests, or performance verification reports from recognized testing organizations.

10. Free Sale Certificate (If Applicable)

• If the device is already marketed in other jurisdictions (e.g., the EU, the US, or other countries), provide a Free Sale Certificate issued by the regulatory authority in that jurisdiction. This document confirms that the device is legally sold and available in the market of the country of origin.

11. Other Supporting Documents

• Test Reports: For specific devices, you may need to submit test reports to demonstrate compliance with international standards (e.g., electromagnetic compatibility (EMC) tests, environmental safety tests, etc.).

• Manufacturing Information: Some medical devices may require manufacturing process documentation, which includes information on how the device is produced, controlled, and tested at the manufacturing facility.

Summary of Required Documents:

1. Product Registration Form (via HPRS portal).
2. Device Description.
3. Declaration of Conformity (e.g., CE marking, FDA approval).
4. Risk Management Report (ISO 14971).
5. Clinical Evaluation Report (if applicable).
6. Quality Management System (QMS) Certification (ISO 13485 or equivalent).
7. Labeling and Instructions for Use (IFU).
8. Sterilization and Biocompatibility Documentation (if applicable).
9. Performance Testing Data (if applicable).
10. Free Sale Certificate (if applicable).
11. Other Supporting Documents (test reports, manufacturing details, etc.).

Ensure all documents are complete, accurate, and well-organized before submission through the HPRS portal. Missing or incomplete documentation can lead to delays or rejection of your registration application.

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