Before applying for A-class medical device registration with the Health Sciences Authority (HSA) in Singapore, there are several key preparatory steps to ensure a smooth application process. These steps will help ensure that your device complies with regulatory requirements, minimize delays, and facilitate a successful registration. Below is a comprehensive list of preparatory work needed before submitting the application.

1. Determine the Correct Classification of the Device

• Verify Device Classification: Ensure that the device indeed qualifies as an A-class medical device under HSA's classification rules. A-class devices are low-risk, and this classification is based on the intended use, risk profile, and contact with the body.
  • Devices that pose the least risk, such as non-invasive, simple devices used for general wellness, often fall under Class A.
  • Use the HSA's classification guidelines or consult with a regulatory expert to confirm the correct classification.

2. Prepare the Quality Management System (QMS)

• Establish or Maintain a QMS: If not already in place, establish a Quality Management System (QMS) in compliance with ISO 13485. While A-class devices are low-risk, a proper QMS is necessary to ensure consistent product quality and adherence to regulatory standards.
  • If your manufacturing process is already certified to ISO 13485, ensure that it is up to date and aligned with the requirements for medical device manufacturing.
• Documenting Quality Assurance: Ensure your QMS covers processes such as design control, manufacturing, risk management, and post-market surveillance.

3. Ensure Regulatory Compliance with HSA's Requirements

• Understand Local Regulatory Requirements: Familiarize yourself with HSA’s specific regulations for A-class devices as outlined in the Health Products Act (HPA) and the Medical Devices Regulations.
• Prepare Device-Specific Information: Gather the necessary technical documentation for your device. This may include:
  • Device description (intended use, indications for use, and any technical specifications).
  • Risk management documentation (following ISO 14971), including a risk analysis, mitigation strategies, and residual risk assessments.
  • Labeling requirements (as per ISO 15223-1), which includes the proper labeling and symbols for the device, in accordance with HSA guidelines.
  • Declaration of Conformity (if applicable), especially if the device is manufactured according to ISO 13485 or other relevant standards.

4. Prepare Required Documentation

Collect and prepare the following essential documents for submission:

Core Documents:

1. Manufacturer’s Details:

   • Company name and address, and details of the manufacturing site(s).
   • Details of the Authorized Representative in Singapore (if applicable).

2. Device Information:

   • Device description and intended use, including any applicable risk classification.
   • Technical file or design dossier, which includes:
     • Device specifications.
     • Manufacturing process.
     • Performance specifications.
     • Risk management documentation.

3. Conformance and Compliance:

   • ISO 13485 Certificate (if applicable), or other relevant QMS certifications.
   • Declaration of Conformity (if the device meets specific international standards such as ISO, IEC, etc.).
   • Risk Management Plan (per ISO 14971).

4. Clinical Evaluation (if applicable): While A-class devices typically do not require clinical data, if any performance or safety claims require evidence, prepare any available clinical data or literature reviews to support your claims.

5. Labeling:

   • Labels and instructions for use (IFU) as per HSA’s guidelines and relevant ISO standards.
   • Ensure that the labels and packaging reflect accurate product information, including safety instructions, intended use, and relevant warnings.

6. Importation and Distribution Details:

   • Details about the importer (if applicable) in Singapore.
   • Evidence that the device will be distributed according to HSA’s regulations and that the importer is properly registered.

5. Verify Compliance with International Standards

• ISO and IEC Standards: Ensure that your device complies with relevant international standards such as:
  • ISO 13485 for QMS.
  • ISO 14971 for risk management.
  • ISO 10993 for biocompatibility (if applicable).
  • IEC 60601 (if the device is electrical or electronic).
  • ISO 15223-1 for labeling and symbols.

Compliance with these standards will likely be necessary for demonstrating the safety and quality of the device to HSA.

6. Set Up Post-Market Surveillance System

• Establish a Post-Market Surveillance (PMS) System: As part of your regulatory obligations, implement a system to monitor the safety and performance of the device once it is on the market.
  • Adverse event reporting procedures should be in place.
  • Recall procedures should be established in case of safety concerns.
  • Be prepared to report serious incidents and corrective actions to HSA as required.

7. Review HSA’s Application Procedures

• Understand the Submission Process: Before submitting, review the HSA's application procedures for medical device registration. Familiarize yourself with the steps involved, such as:
  • Online registration via the HSA’s Health Products e-Services portal.
  • Ensuring that all forms are completed accurately and that all required documentation is included.
• Fees and Payment: Prepare for any registration fees that may apply. A-class devices typically have a lower registration fee compared to higher-risk devices, but be sure to check the exact amount based on the HSA’s fee schedule.

8. Assign an Authorized Representative (if applicable)

• If your company is not based in Singapore, you must appoint an authorized representative in Singapore who will act as the point of contact with HSA. The authorized representative must be a local entity that is registered with HSA and able to handle regulatory submissions, device importation, and compliance matters.

9. Prepare for an Inspection (if applicable)

• Inspection Readiness: In some cases, HSA may inspect the manufacturing facility before registration, especially if the device is new to the market. Ensure that your facility is in compliance with Good Manufacturing Practices (GMP) and that all records are available for inspection.

10. Timeframe Planning

• Plan for Time Requirements: The process for A-class device registration can take a few weeks to a few months, depending on the completeness of your submission and whether any additional information is required by the HSA. Ensure that you account for this in your product launch timeline.

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