How to Get Your Medical Device Import Licence in Singapore: Expert Guide 

Obtaining a medical device import licence in Singapore involves navigating the Health Sciences Authority (HSA)’s structured regulatory framework. All importers must be licensed by HSA, and every medical device must be registered in the Medical Device Information Communication System (MEDICS) according to its risk classification from Class A (low risk) to Class D (high risk). For overseas manufacturers, appointing a local authorised representative is also required. 

This guide outlines the key steps to secure your medical device import licence and ensure compliance with Singapore’s regulatory requirements. 

Step 1: Check If Your Device Needs a Licence 

Your first significant step to get a medical device import licence in Singapore starts with checking if your product needs registration. This step will help you follow HSA regulations and avoid delays when entering the market. 

How to identify if your product is a medical device 

In Singapore, medical devices are defined as health products that have a physical or mechanical effect on the human body. They’re typically used to diagnose, treat, or monitor medical conditionsl, for example; blood pressure monitors or blood glucose meters. 

On the other hand, products meant purely for general wellness, such as body toning machines, magnetic accessories, or massagers, don’t fall under this category. 

If you’re unsure about your product’s classification, HSA offers a handy online tool called “Is it a medical device” to help you check whether your product is regulated as a medical device in Singapore. 

Devices exempt from registration 

Not all medical devices require registration before importation into Singapore. Class A medical devices, representing the lowest risk category, are exempted from product registration requirements. Nevertheless, companies dealing with Class A devices must still: 

• Obtain an Importer’s Licence from HSA 

• Complete the Class A Exemption List in MEDICS during the dealer’s licence application 

• Ensure devices conform to Essential Principles for Safety and Performance 

• Maintain a Quality Management System (QMS) 

For Class A sterile medical devices, dealers must ensure that sterilisation processes conform to international standards such as ISO 11135, ISO 11137, or equivalent. 

Using the Singapore Medical Device Register 

The Singapore Medical Device Register (SMDR) is a comprehensive database of all medical devices registered with HSA. Only registered medical devices may be imported into Singapore, except for exempted Class A products. 

Prior to applying for an import licence, checking the SMDR helps determine if: 

• Your device is already registered in Singapore 

• Similar devices exist in the market 

• Your device requires new registration 

Searching the SMDR provides valuable insights regarding the classification and registration status of comparable products currently approved in Singapore. 

Step 2: Classify Your Device and Choose the Right Route 

After confirming your product requires registration, accurate classification of your medical device is essential as it determines the regulatory pathway. Singapore follows a risk-based approach for medical device classification that aligns with global standards. 

Understanding Class A, B, C, and D devices 

Singapore categorises medical devices into four classes: 

• Class A: Low risk devices like wheelchairs, tongue depressors, and surgical masks 

• Class B: Low to moderate risk devices including hypodermic needles, contact lenses, and hearing aids 

• Class C: Moderate to high risk devices such as ventilators, bone fixation plates, and X-ray machines 

• Class D: High risk devices including heart valves, implantable defibrillators, and pacemakers 

Classification depends on factors like duration of body contact, invasiveness, delivery of medicinal products, biological effects, and local versus systemic effects. 

How to select the correct evaluation route 

Singapore offers four evaluation routes for medical device registration: 

1. Full Route: For devices without prior approval from reference regulatory agencies 

2. Abridged Route: For devices with approval from at least one reference regulatory agency 

3. Expedited Routes: Class-specific fast-track options for devices meeting certain criteria 

4. Immediate Routes: For eligible Class B devices and standalone medical mobile applications 

Your choice significantly affects processing time and costs. Consequently, selecting the appropriate route is crucial for efficient market entry. 

Eligibility for expedited or abridged routes 

Expedited routes have specific eligibility requirements: 

• Class C Expedited Route (ECR-1): Requires approval from one reference agency, three years of marketing history, and no global safety issues 

• Class C Expedited Route (ECR-2): Requires approvals from at least two reference agencies 

• Class D Expedited Route (EDR): Requires approvals from at least two reference agencies 

All but one of these routes exclude active implantable devices, central circulatory system implants, and HIV testing devices. 

Approval must come from recognised authorities like FDA (US), TGA (Australia), Health Canada, EU Notified Bodies, or Japan’s MHLW. 

Step 3: Submit Your Application via MEDICS 

Your next step after device classification involves submitting your application through Singapore’s MEDICS system, the official online portal for medical device registrations. 

How to apply import licence in Singapore 

Businesses need a CRIS account with HSA to access the MEDICS e-service system. The platform handles all communications about submissions and registrations digitally. Importers must submit applications through MEDICS under their licence entity and maintain appropriate dealer licences. 

Documents required for each route 

Essential documents typically include: 

• ASEAN Common Submission Dossier Template (CSDT) with Singapore-specific labelling 

• Quality Management System certification (ISO 13485 or GDPMDS certificate) 

• Device technical documentation 

• Evidence of approvals from reference regulatory agencies (for abridged/expedited routes) 

Import licence Singapore cost and processing time 

The costs and processing times vary by licence type: 

• Importer’s Licence: Around SGD 1,500 with 10 working days processing time 

• Licence amendments: Around SGD 200 

• Annual renewal fees match initial application fees 

Tips for smooth communication with HSA 

HSA issues Input Requests (IR) through MEDICS if they need more information. Registrants get automatic notifications and should respond quickly. HSA also offers pre-market consultations, a chance to discuss clinical aspects of medical device development or pre-submission documentation requirements. 

Step 4: Prepare for Compliance and Market Entry 

Your medical device import licence marks the beginning of complete compliance preparations needed for Singapore market entry. The post-approval phase needs you to focus on quality standards and operational procedures. 

Getting GDPMDS certified 

Securing Good Distribution Practise for Medical Devices (GDPMDS) certification is mandatory before applying for an Importer’s Licence. This certification verifies that importers possess appropriate quality management systems, procedures, and facilities to handle medical devices properly. Certification must be performed by bodies accredited by the Singapore Accreditation Council (SAC). Companies dealing exclusively with Class A devices may submit a declaration of conformity to a Quality Management System instead. 

Setting up quality systems and SOPs 

Quality systems must maintain device quality throughout the distribution process. Essential components include document control, management responsibility, corrective actions, and internal audits. Establish proper procedures for transportation, storage, and traceability of medical devices. These systems ensure that medical devices are consistently stored, transported, and handled under suitable conditions. 

First 3 months: audit readiness and operational setup 

Start by training employees in all distribution activities. Make sure you document both original and refresher courses properly. Set up systems that manage customer complaints and handle product recalls effectively. Stay ready for HSA audits because they can revoke your licence if you don’t comply. 

Renewal and maintenance of your import licence 

Import licences remain valid for 12 months from approval. Renewal options include: 

• Auto-renewal via GIRO: Activated 30 days before expiry 

• Manual renewal: Submit 60 days before expiry 

Ensure sufficient GIRO account balance 45 days before expiry to prevent unsuccessful renewals. For licence cancellation, submit applications before the next GIRO deduction to avoid unnecessary charges. 

How Nyprax Can Help 

Navigating Singapore’s medical device regulations becomes straightforward with the right partner. Nyprax Pharma offers specialised support throughout the licencing journey, backed by over 30 years of regulatory experienceand more than 5,000 successfully registered medical devices. 

As your designated local licence holder, Nyprax manages the entire regulatory process whilst you focus on your core business operations. Their comprehensive services encompass: 

• Submitting applications through the HSA MEDICS system under their licence entity 

• Responding to HSA technical queries and providing additional data when required 

• Maintaining your import licence with ongoing support for audits and renewals 

For companies without a physical presence in Singapore, Nyprax serves as your official medical device import licence holder, enabling market entry even without establishing a local entity. Our in-depth knowledge of HSA procedures allows for efficient submissions and reduced approval times. 

Beyond registration, Nyprax offers end-to-end compliance management and tailors their approach based on your specific product, region of origin, and business model, ensuring smooth regulatory alignment throughout the process. 

Upon approval, Nyprax provides continuous support through the critical first three months, helping establish quality systems, prepare for potential HSA audits, and ensure operational readiness for the Singaporean market, ultimately streamlining your path to successful medical device importation in Singapore. 

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