HSA Licence

HSA Licence | Bestar

HSA Licence

A Health Sciences Authority (Hsa) licence is a mandatory permit required in Singapore to manufacture, import, wholesale, or supply health products like medicines, medical devices, active ingredients, and tobacco.

Key Types of HSA Licences

• Dealer's Licence: Needed for businesses that manufacture, import, or supply medical devices. Low-risk Class A devices use a product notification system via the SHARE E-System instead.

  
  

• Manufacturer's, Importer's & Wholesaler's Licences: Required for handling therapeutic products, active ingredients, or controlled drugs. These often require a designated Responsible Person (RP).

  
  

• Retail Licences: Required for specific retail activities, such as selling tobacco products, processed through GoBusiness Licensing.

Application Requirements

• CRIS Account: Companies must register a CRIS company account with the HSA.

  
  

• Corppass: Applications are completed online using corporate digital identities.

  
  

• Compliance Standards: Facilities may need to pass Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP) audits before approval.

If you share what specific product or activity your business handles (such as importing medical devices, retailing tobacco, or manufacturing active ingredients), we can give you the exact application steps and portal details.

Business activity

The application steps, strict quality requirements, and target web portals vary significantly depending on which of these three distinct activities your business handles.

🩺 1. Importing Medical Devices

To legally bring medical devices into Singapore, you must obtain a Medical Device Importer's Licence under the Health Products (Medical Devices) Regulations.

• Primary Portal: Applications must be submitted online through the SHARE E-Service Portal.

  
  

• Quality Requirement: Your company's distribution facilities must be certified to Good Distribution Practice for Medical Devices (GDPMDS) or ISO 13485 standards.

  
  

• Crucial Prerequisite: Beyond your dealer licence, the individual medical devices themselves must be formally registered in the Singapore Medical Device Register (SMDR) before import, unless they qualify as exempted Class A low-risk devices.

🚬 2. Retailing Tobacco Products

Tobacco licences are outlet-specific. If your business operates multiple retail locations, you must secure a separate Tobacco Retail Licence for each distinct address.

• Primary Portal: Applications are processed through the government's centralized GoBusiness Licensing Portal.

  
  

• Prohibited Locations: HSA will automatically reject applications for locations situated inside medical clinics, hospitals, pharmacies, Traditional Chinese Medicine (TCM) halls, gaming arcades, or youth-centric institutions (like schools and childcare centers).

  
  

• Operational Rule: You are legally prohibited from selling any tobacco items while your application is pending; sales may only commence after the actual licence is approved and issued.

🧪 3. Manufacturing Active Ingredients

Manufacturing chemical or biological active ingredients for commercial supply requires a Manufacturer's Licence under the Health Products (Active Ingredients) Regulations.

• Primary Portal: Online applications are submitted using the PRISM Portal (Pharmaceutical Regulatory Information System).

  
  

• Quality Requirement: Your manufacturing facility must strictly comply with Good Manufacturing Practice (GMP) standards.

  
  

• The Process: HSA inspectors will schedule an on-site pre-approval inspection within 3 months of your submission. Once all inspection findings are successfully resolved, HSA issues the electronic licence within 10 working days.

Common Onboarding Requirements

Regardless of the track, your business must establish its digital identity setup before applying:

1. Secure a valid CorpPass account via your company's Singpass Business profile.

   
   

2. Set up a CRIS Account (Client Registration and Identification Service) on the HSA Website to link your CorpPass with HSA e-services.

Which of these three paths match your immediate business goals? If you tell us the specific risk class of your medical device (Class A to D) or your target manufacturing launch date, we can provide details on timelines and fees.

Risk Class of Medical Device (Class A to D)

In Singapore, the Health Sciences Authority (HSA) categorizes medical devices into four distinct risk classes (Class A to D). The specific risk class determines whether your product requires formal pre-market registration and governs the evaluation route, regulatory fees, and processing times.

HSA Medical Device Classification Framework

Risk Class	Risk Level	Pre-Market Product Registration	Common Examples	Evaluation Route Options
Class A	Low Risk	🚫 Exempt (Listing only via SHARE Portal)	Surgical masks, wheelchairs, bandages, tongue depressors	No product registration required (unless sterile)
Class B	Low-to-Moderate	Mandatory	Syringes, contact lenses, hearing aids, dental crowns	Immediate, Abridged, or Full
Class C	Moderate-to-High	Mandatory	Lung ventilators, X-ray machines, infusion pumps	Immediate, Abridged, Expedited, or Full
Class D	High Risk	Mandatory	Heart valves, pacemakers, breast implants, defibrillators	Abridged, Expedited, or Full

How Risk Class Affects Your Registration Path

🟢 Class A (Low Risk)

• The Process: These items are exempt from pre-market product evaluation. Your licensed importer simply declares and lists them in the Class A Device Database prior to import.

  
  

• Exception: Sterile Class A devices do require an entry registration process.

🟡 Class B, C, and D (Moderate to High Risk)

Before you can market or import these devices, a locally registered company acting as the Registrant must submit a technical dossier via the HSA E-Systems. The pathway options depend entirely on prior global approvals:

1. Immediate Route: Available for eligible Class B and C devices that already hold approvals from at least two of HSA’s recognized global reference agencies (e.g., US FDA, EU CE Mark, Health Canada, Australia TGA, or Japan MHLW). This permits near-instant market listing upon submitting the application.

   
   

2. Abridged / Expedited Route: Uses the reference approvals from overseas agencies to bypass full testing. It features lower fees and shortened Turn-Around Times (TAT), typically ranging from 60 to 120 working days.

   
   

3. Full Evaluation Route: Mandated if your device has no prior approvals from any global reference agency. This requires heavy clinical and technical dossier reviews and can take 160 to 310 working days.

Standard Fee Structure

An application fee applies to any Class B, C, or D submission. Once approved, registrations do not expire as long as the registrant pays the mandatory Annual Retention Fee to maintain the device listing in the Singapore Medical Device Register (SMDR).

If you tell me what specific medical device you intend to import, or if it already has overseas regulatory approvals (like US FDA or CE Mark), I can help you pinpoint its exact risk class and the fastest registration pathway.

For medical advice or diagnosis, consult a professional. Learn more

Overseas regulatory Approvals (US FDA or CE Mark)

Because your medical device already holds US FDA approval or an EU CE Mark, it qualifies for HSA’s "Reliance Pathways" (Abridged, Expedited, or Immediate Evaluation). Both the US FDA and EU CE marking systems are officially recognized independent reference regulatory agencies by the HSA.

This prior certification allows your business to leverage existing technical data, bypass a full technical review, drastically reduce processing fees, and achieve much faster local approval. ]

⚡ Available Fast-Track Pathways Based on Your Existing Approvals

🎯 1. The Abridged Evaluation Route

• Eligibility: Your device needs approval from at least one reference agency (either US FDA or CE Mark matches this perfectly) for the exact same labeled use intended for Singapore.

  
  

• The Advantage: Around 98% of qualified foreign devices pass through this route. It cuts down documentation requirements to summary quality data and certifications rather than raw clinical trials.

  
  

🚀 2. The Immediate or Expedited Routes

• Eligibility for Immediate (Class B & C): If you possess both the US FDA and CE Mark approvals (or one approval plus a safe marketing history of at least 3 years with zero global safety recalls), you may qualify for the immediate or expedited routes.

  
  

• The Advantage: Provides instantaneous or accelerated listing onto the Singapore Medical Device Register (SMDR), cutting time-to-market down from months to days or weeks.

  
  

📋 Strict Identity and Mapping Requirements

To successfully submit under a reliance pathway, you must prove absolute consistency across your paperwork:

• The "Identical" Rule: The physical device intended for Singapore must be completely identical in design, specifications, intended use, manufacturing materials, and technical labeling to the version approved by the US FDA or CE Mark.

  
  

• The Local Registrant: Foreign manufacturers cannot apply directly. You must appoint a locally registered corporate entity in Singapore to act as the Registrant to manage the submission via the MEDICS System.

  
  

• Manufacturing Proof: You must submit a certified true copy of the ISO 13485 Quality Management Certificate for every manufacturing site involved in making the device.

If you can share the exact risk classification of your device (Class B, C, or D) or if you have both approvals or just one, we can map out your precise turnaround times and required application documents.

Exact Risk Classification of Device (Class B, C, or D) or Holding Both Approvals or just One

Your choice of evaluation pathway, target timelines, and government fees depend entirely on the exact risk class of your medical device (Class B, C, or D) combined with whether you hold one approval or both (US FDA and EU CE Mark).

The structural blueprint below maps out how these combinations dictate your local registration strategy:

🗺️ The Application Strategy Blueprint

🟢 1. Your Device is Class B (Low-to-Moderate Risk)

• If you have BOTH approvals: You qualify for the Immediate Route. Your device achieves an instantaneous listing on the Singapore Medical Device Register (SMDR) right at submission.

  
  

• If you have ONLY ONE approval: You can still utilize the Immediate Route if your device has a clean safety record and at least 3 years of marketing history in that specific jurisdiction. Otherwise, it drops to the Abridged Route.

  
  

• Timeline & Costs:

  
  

  • Immediate Route: Immediate turn-around time (TAT) | $1,560 SGD total fee ($560 application fee + $1,000 evaluation fee).

  • Abridged Route: 100 working days TAT | $2,570 SGD total fee ($560 application fee + $2,010 evaluation fee).

🟡 2. Your Device is Class C (Moderate-to-High Risk)

• If you have BOTH approvals: You can leverage the Expedited Route (which waives a significant portion of the dossier review). Alternatively, if the device is a standalone medical mobile app, it may bypass to the Immediate Route.

  
  

• If you have ONLY ONE approval: Your standard fast track is the Abridged Route, utilizing the single reference agency documentation to bypass full testing.

  
  

• Timeline & Costs:

  
  

  • Immediate/Expedited Route: Immediate to 120 working days TAT | $3,900 SGD total fee ($560 application + $3,340 evaluation fee).

  • Abridged Route: 160 working days TAT | $4,460 SGD total fee ($560 application + $3,900 evaluation fee).

    
    

🔴 3. Your Device is Class D (High Risk)

• If you have BOTH approvals: You qualify for the Expedited Route for high-risk devices, compressing the deep regulatory analysis dramatically.

  
  

• If you have ONLY ONE approval: Your device follows the Abridged Route, requiring a more targeted review of your clinical data.

  
  

• Timeline & Costs:

• 
  

  • Expedited Route: 180 working days TAT | $6,490 SGD total fee ($560 application + $5,930 evaluation fee).

  • Abridged Route: 220 working days TAT | $6,810 SGD total fee ($560 application + $6,250 evaluation fee).

⚠️ Essential Regulatory Contingencies

1. The "Dual Reference" Rule: If you are claiming eligibility based on having both approvals, be aware that HSA treats EU CE Mark and Australia TGA as a single correlated approval if they share the same underlying technical review. A US FDA approval plus a CE Mark counts cleanly as two independent approvals.

   
   

2. Global Safety Record: To use any immediate or expedited pathway, your device must have zero global safety recalls, withdrawals, or open safety alerts within the past 3 consecutive years.

   
   

3. The Local Registrant: Ensure your local corporate partner submits everything through the HSA SHARE Portal using a corporate CorpPass profile.

Which specific configuration applies to your device (e.g., "Class C with both approvals" or "Class B with only US FDA")? If you share that, we can provide you with the exact technical dossier check-list required for submission.

Securing an HSA Licence in Singapore: How Bestar Streamlines Your Regulatory Compliance

Navigating the Health Sciences Authority (HSA) licensing framework in Singapore can be complex for biomedical, pharmaceutical, and medical device companies. Minor technical errors during submission can lead to extensive review delays or outright rejections.

Partnering with an experienced corporate support and regulatory consultancy like Bestar ensures a smooth, efficient application process. This article explains how Bestar helps businesses secure their HSA licences, establish robust Quality Management Systems (QMS), and maintain strict compliance with local regulations.

What is an HSA Licence and Who Needs One?

An HSA Licence is a mandatory legal permit required under the Health Products Act to manufacture, import, wholesale, or retail regulated health products in Singapore. This includes:

• Therapeutic Products (Western medicines)

• Medical Devices (Class A, B, C, and D)

• Active Ingredients (Chemical or biological bulk substances)

• Chinese Proprietary Medicines and cosmetic items

Without the appropriate approved dealer's or manufacturer's licence, distributing these products in or through Singapore carries severe legal penalties.

How Bestar Helps You Secure and Maintain Your HSA Licence

Bestar provides end-to-end operational support, bridging the gap between complex regulatory requirements and practical corporate deployment.

[Company Setup & CRIS] ➔ [QMS & SOP Drafting] ➔ [PRISM/SHARE Submission] ➔ [HSA Audit Defense]

1. Pre-Requisite Corporate Setup & Portal Registration

Before applying for any licence, your business must establish a valid local entity.

• ACRA Incorporation: Bestar handles your full Singapore company incorporation, corporate secretarial duties, and CorpPass configuration.

  
  

• CRIS Account Activation: Bestar manages the setup of your Client Registration and Identification Service (CRIS) account, linking your corporate Singpass profile directly to HSA’s digital portals.

2. Quality Management System (QMS) & SOP Drafting

HSA mandates that importers, wholesalers, and manufacturers operate under strict quality frameworks. Bestar drafts and tailors all your necessary Standard Operating Procedures (SOPs) to clear regulatory bars:

• Good Distribution Practice (GDP / GDPMDS): Essential for medical device and therapeutic product importers. Bestar structures your documentation to meet required temperature-logging, product segregation, and trace-back rules.

  
  

• Third-Party Logistics (3PL) Models: If you utilize a outsourced warehouse, Bestar structures Master Services Agreements and delineates responsibilities between your firm, the 3PL provider, and regulators.

3. Sourcing a Certified Responsible Person (RP)

Under the Health Products Regulations, businesses applying for a Therapeutic Products Importer's or Wholesaler's Licence must designate a qualified Responsible Person (RP)—typically a Singapore-registered pharmacist.

• Vetting and Recruitment: Bestar actively sources and vets qualified part-time or full-time Singapore-registered pharmacists to step into your RP role.

  
  

• Risk Mitigation: To safeguard your operations, Bestar implements a 90-day replacement mechanism; if your onboarded RP becomes unavailable early on, Bestar provides an alternate candidate at no extra professional fee.

4. Managing Portals and Regulatory Queries (PRISM & SHARE)

Submitting documentation incorrectly can reset your evaluation timelines. Bestar manages the entire online filing process:

• Medical Devices: Submissions are routed expertly through the SHARE E-Service Portal.

  
  

• Pharmaceuticals & Active Ingredients: Submissions are processed through the PRISM Portal.

  
  

• Query Defenses: When HSA officers issue technical inquiries or clarify dossiers, Bestar formulates and submits regulatory responses within compressed timelines (typically within 3 business days) to prevent applications from lapsing.

5. Audit Representation and Pre-Approval Audits

HSA frequently requires pre-approval physical site inspections before issuing a licence. Bestar works directly alongside your team during these inspections:

• Conducting pre-audit mock drills to catch potential compliance flags.

  
  

• Acting as your regulatory liaison during physical HSA site inspections.

  
  

• Formulating immediate Corrective and Preventive Action (CAPA) plans if deficiencies are noted by auditors.

Frequently Asked Questions (FAQs)

How long does it take to get an HSA licence with Bestar?

Turnaround times depend on your product risk tier. For companies with existing US FDA or CE Mark approvals, Bestar can help leverage reliance pathways—reducing timelines to immediate listings or compressed 60-to-120 working day cycles. For completely new full-evaluation products, processing can take up to 310 working days.

Can Bestar act as our local registrant in Singapore?

Foreign manufacturers cannot interface directly with HSA e-services. Bestar can help configure your local subsidiary or guide your appointed local distributor to handle the Registrant duties safely under corporate secretarial compliance frameworks.

What happens if our warehouse fails an HSA GDP audit?

If an audit uncovers gaps, your application is suspended until resolved. Bestar helps you draft a prompt response plan, rectifies your quality manual, implements proper control steps, and coordinates a re-inspection with the HSA.

Contact Bestar for a Regulatory Consultation

Accelerate your time-to-market and protect your regulatory status in Singapore. For expert assistance with your company setup, QMS drafting, or HSA license application, connect with the specialist team at Bestar.

• 🏢 Address: Bestar Services Pte. Ltd., 23 New Industrial Road, #04-08 Solstice Business Center, Singapore 536209

• 📞 Phone: +65 62994730 / +65 8836 4489

• 📧 Email: admin@bestar-asia.com

• 🌐 Official Website: Bestar

Are you seeking an HSA licence for medical devices, therapeutic medicines, or active ingredients? Let us know your specific health product type so we can outline the precise compliance checklists Bestar uses for that application pathway.