Pre-Market Consultation Schemes for Medical Devices in Singapore

1. Overview

The Health Sciences Authority (HSA) provides voluntary pre-submission consultation schemes to facilitate dialogue with applicants before formal submission of applications related to medical devices. These consultations aim to clarify regulatory requirements, discuss dossier preparation, and improve submission quality, thereby reducing review time and potential queries. Source: https://www.hsa.gov.sg/medical-devices/consultation-schemes

2. Types of Consultation Schemes

HSA offers several targeted consultation services:

• Pre-Submission Consultation for Medical Device Registration — For new or major change applications for Class B, C, or D devices.
• Pre-Licensing Consultation — For dealer’s licence applications (manufacturer, importer, wholesaler).
• Pre-Approval Consultation for Clinical Trials — To discuss trial design, risk classification, and exemption criteria.
• Innovation Pathway Consultation — For novel or breakthrough devices to explore regulatory pathways and evidence requirements.
• General Regulatory Clarification — For any other pre-submission queries on classification, grouping, or requirements.

Source: https://www.hsa.gov.sg/medical-devices/consultation-schemes

3. Eligibility and Scope

Consultations are available to:

• Local and overseas manufacturers.
• Singapore-based importers, wholesalers, or authorised representatives.
• Sponsors or investigators planning clinical trials in Singapore.

Discussions cover regulatory strategy, dossier requirements, clinical data expectations, QMS issues, and classification queries. Consultations do not constitute formal approval or guarantee of outcome. Source: https://www.hsa.gov.sg/medical-devices/consultation-schemes

4. Application Process

• Submit a consultation request via the online form on the HSA website.
• Provide a brief background, specific questions, and relevant documents (e.g., draft protocol, device description).
• HSA reviews the request and schedules a meeting (virtual or in-person) if accepted.
• Processing time for scheduling is typically within 10–15 working days.

Source: https://www.hsa.gov.sg/medical-devices/consultation-schemes

5. Meeting Format and Outcomes

• Meetings involve HSA officers from relevant branches (e.g., Device Registration, Clinical Trials).
• Applicants present their case and receive feedback on regulatory expectations.
• Minutes or written feedback are provided post-meeting.
• No binding decisions are made; formal applications follow standard review processes.

Source: https://www.hsa.gov.sg/medical-devices/consultation-schemes

6. Fees and Important Notes

• Most consultations are free of charge, though some complex or follow-up sessions may incur fees.
• Applicants are encouraged to prepare specific questions to maximise the value of the session.
• Consultations are advisory only and do not replace formal submission requirements.
• Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/medical-devices/consultation-schemes

7. Related Resources

Refer to specific guidance documents (e.g., GN-15 for registration, CTN for trials) for detailed requirements before requesting consultation. Source: https://www.hsa.gov.sg/medical-devices/consultation-schemes