How long does it take to get the HSA Dealer’s Licence?

Typical processing ranges from 2–6 weeks depending on completeness of submission and response time to HSA Input Requests.

Is GDPMDS mandatory for importers and wholesalers?

Yes, importers and wholesalers must hold SS 620 (GDPMDS) or ISO 13485 with distribution scope unless dealing only with Class A devices.

How much does the HSA Dealer’s Licence application cost?

HSA charges SGD 500 for a new Importer or Wholesaler licence, and SGD 1,000 for a Manufacturer’s licence. Renewal fees apply annually.

How to Apply for an HSA Medical Device Dealers Licence in Singapore (2025 Guide: Manufacturer, Importer, Wholesaler)

Q: What platform is used to submit the application?

All dealer’s licence applications must be submitted via the SHARE (Singapore Health Product Access and Regulatory E-System) portal.

The Health Sciences Authority (HSA) regulates all companies involved in manufacturing, importing, and wholesaling medical devices in Singapore. Every dealer must hold a valid Medical Device Dealer’s Licence and maintain a Quality Management System (QMS) appropriate to the activities performed.

All licence applications must be submitted via the SHARE (Singapore Health Product Access and Regulatory E-System) online platform.

1. Determine the Correct Licence Type and QMS Requirement

HSA issues three types of Medical Device Dealer’s Licences. Each licence type has a mandatory QMS requirement aligned with the company’s operations.

Regardless of licence type, every dealer must implement a documented Quality Management System (QMS).

1.1 Licence Types and Activities

Manufacturer’s Licence
Activity: Manufacturing, fabricating, processing, packaging, or labelling medical devices in Singapore.
QMS Requirement: ISO 13485 or MDSAP.
Importer’s Licence
Activity: Importing medical devices into Singapore.
QMS Requirement: SS 620 (GDPMDS) or ISO 13485 (with distribution scope).
Wholesaler’s Licence
Activity: Wholesale supply or export of medical devices.
QMS Requirement: SS 620 (GDPMDS) or ISO 13485 (with distribution scope).

1.2 Acceptable QMS Documentation for Submission

Depending on the regulatory scenario, one of the following documents must be provided:

Scenario: Handling non-Class A devices (Import/Wholesale)

Required Document: SS 620 (GDPMDS) Certificate or ISO 13485/MDSAP Certificate (distribution scope)

Applicable Licence: Importer, Wholesaler

Scenario: Manufacturer of medical devices

Required Document: ISO 13485 or MDSAP Certificate

Applicable Licence: Manufacturer

Scenario: Handling Class A devices only

Required Document: Declaration of Conformity to a QMS (Annex 5)

Applicable Licence: All Licences

Scenario: Export-only or re-export operations

Required Document: Declaration for Export/Re-export Purposes (Annex 1)

Applicable Lucence: Importer & Wholesaler

All certificates must be issued by a Singapore Accreditation Council (SAC)–accredited certification body.

2.Prepare Company Details and Supporting Documents

Before submitting the licence application, ensure the following:

Company registration (ACRA): The business profile and registered address must match the details in the SHARE application.
QMS certificate or declaration: The final approved QMS document must be ready for upload.
Applicant and point-of-contact details: Email, telephone, and contact information must be accurate to ensure HSA can issue Input Requests (IRs) and updates.

3. Submit the Dealer’s Licence Application on SHARE

Submit a New Application for the relevant licence type.
HSA follows this sequence:

Screening of the application for completeness.
Input Request (IR) if additional documents or clarifications are needed.
Review of submitted responses.
Approval, withdrawal, or rejection depending on compliance.

If the applicant does not respond within the required timeframe, HSA may reject or require withdrawal of the submission. Any re-submission will be treated as a new application.

4. Complete Product Notification for Class A Medical Devices (If Applicable)

Manufacturers and importers of Class A medical devices must notify their products before supplying them in Singapore.

This includes:

Submitting a Product Notification via SHARE prior to import or supply.
Ensuring listed products appear in the Class A Medical Device Database.
Submitting an Amendment under “Product Notification” for any product changes before importing or supplying the updated version.

5. Maintain, Renew, and Update the Dealer’s Licence

5.1 Licence Validity

All HSA Dealer’s Licences are valid for 12 months from the approval date.

5.2 Renewal Requirements

Renewal must be submitted at least 14 calendar days before licence expiry.
Renewal is done via SHARE → Licence → Renewal Application.
Companies enrolled in GIRO are eligible for automatic renewal, with reminders sent 60, 45, and 30 days before expiry.

5.3 Licence Amendments

A Licence Amendment is required for any change to:

Operating site or warehouse address
Device type (General Medical Device or IVD)
Risk classification
QMS certification (renewal or update)

The updated QMS document must be uploaded as part of the amendment process.

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6.FAQ For HSA Medical Device Dealer’s Licence in Singapore (Manufacturer, Importer, Wholesaler

1. What is the HSA Medical Device Dealer’s Licence?

It is a mandatory licence issued by Singapore’s Health Sciences Authority (HSA) that allows companies to legally manufacture, import, or wholesale medical devices.

2. Who needs to apply for a Dealer’s Licence?

Any business in Singapore involved in manufacturing, importing, or wholesaling medical devices, regardless of scale, must hold a valid HSA Dealer’s Licence.

3. What QMS certification is required for the application?

Importers and wholesalers typically require SS 620 (GDPMDS) or ISO 13485 (distribution scope).
Manufacturers require ISO 13485 or MDSAP.

4. How long does it take to get the licence approved?

HSA’s review process typically takes 2–6 weeks, depending on the completeness and accuracy of submissions.

5. What platform is used to submit the licence application?

All applications must be submitted through the SHARE (Singapore Health Product Access and Regulatory E-System) portal.

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