The global medical device market is projected to exceed $600 billion by 2030, with online sales growing at 15% annually. Yet despite this explosive growth, many medical device companies overlook Shopify as a viable platform—mistakenly believing that healthcare e-commerce requires only specialized, expensive infrastructure.
The truth is more nuanced: Shopify can absolutely power a compliant, successful medical device store—but only if you understand and implement the unique regulatory, operational, and payment requirements that distinguish healthcare e-commerce from mainstream retail.
This comprehensive guide walks you through launching a medical device store on Shopify, addressing FDA compliance, B2B-B2C dynamics, payment processing, and the documentation requirements that regulators expect.
Understanding the Medical Device Market
Before building your Shopify store, you need to understand what you're selling and who you're selling to.
Market Size and Growth Drivers
The medical device market encompasses everything from bandages to orthopedic implants. The e-commerce segment includes:
- Home healthcare equipment ($45B market): Mobility aids, monitoring devices, respiratory equipment
- Orthopedic and prosthetic supplies ($28B market): Braces, supports, corrective devices
- Diagnostic and monitoring devices ($52B market): Glucose monitors, blood pressure cuffs, pulse oximeters
- Wound care and ostomy supplies ($18B market): Dressings, catheters, pouching systems
- Physical therapy and rehabilitation equipment ($15B market): Resistance bands, exercise equipment, recovery devices
- Mobility and accessibility aids ($12B market): Walkers, canes, wheelchairs, transfer equipment
Online sales dominate in B2C segments (especially consumables like wound care and monitoring supplies) while B2B distribution remains critical for hospital and clinical supplies.
Why Medical Devices Are Different from Regular E-commerce
Medical devices operate under a fundamentally different regulatory framework than consumer products. Three factors distinguish them:
1. FDA Oversight and Classification
Every medical device sold in the US must be FDA-regulated based on intended use. The FDA classifies devices into three categories:
- Class I (lowest risk): Bandages, elastic compression bands, basic thermometers. Typically require general controls only.
- Class II (moderate risk): Blood pressure monitors, CPAP machines, mobility aids. Require premarket notification (510k).
- Class III (highest risk): Implantable devices, pacemakers, artificial joints. Require premarket approval (PMA).
Your Shopify store's compliance requirements depend entirely on which classes you sell.
2. Evidence-Based Claims and Substantiation
Unlike consumer products, medical devices cannot make unsupported health claims. You must substantiate any therapeutic or health benefit with clinical evidence. This shapes your product descriptions, marketing content, and even your email campaigns.
3. Ongoing Regulatory Reporting
Selling medical devices creates ongoing compliance obligations. You must track adverse events, implement corrective actions, maintain quality documentation, and respond to FDA inquiries. It's not a set-it-and-forget-it operation.
FDA Compliance: The Non-Negotiable Foundation
Launching a compliant medical device store requires navigating FDA requirements. Here's the operational roadmap:
Step 1: Establish Your Regulatory Status
First, determine how the FDA categorizes your business:
Medical Device Manufacturer: You design, develop, or modify medical devices.
- Must register with FDA
- Must obtain Device Listing Numbers (DLN) for each product
- Responsible for quality systems and adverse event reporting
- Responsible for premarket submissions (510k or PMA)
Medical Device Distributor: You purchase finished devices from manufacturers and resell them.
- Must register with FDA as a distributor
- Less responsibility for design/development but still liable for appropriate distribution
- Must ensure manufacturer compliance and maintain traceability
- Still responsible for adverse event reporting
Repackager/Relabeler: You take manufacturer products and repackage or relabel them.
- Triggers additional FDA requirements
- May trigger reclassification requiring new premarket submissions
- Requires quality system documentation
Most Shopify medical device stores operate as distributors or small manufacturers. Your registration status directly impacts your Shopify store setup.
Step 2: FDA Registration and Device Listing
All medical device manufacturers and distributors must register with the FDA and maintain current registration.
How to register:
- Visit FDA's Unified Registration and Listing System (FURLS)
- Create a user account
- Register your establishment and receive a Unique Facility Identifier (UFI)
- List each device product with a Device Listing Number (DLN)
Registration is free but must be renewed annually. The FDA sends renewal notices each October. Missing the deadline can result in enforcement action, so add this to your compliance calendar.
For each product, you must provide:
- Product name and intended use
- Device classification (Class I, II, or III)
- Premarket submission numbers (if applicable)
- Device Type Code (identifies specific device category)
Step 3: Premarket Submissions (510k or PMA)
This is where most medical device retailers encounter complexity.
Class I devices generally don't require premarket submissions. You can sell immediately after registration.
Class II devices require a 510(k) premarket notification. This submission demonstrates that your device is substantially equivalent to a legally marketed predicate device. The process typically takes:
- 30-90 days for FDA review
- 2-4 weeks to prepare the submission
- Requires technical data, performance testing, and predicate device justification
Class III devices require a Premarket Approval (PMA) application. This is a comprehensive submission with clinical trial data, manufacturing information, and labeling. PMA review can take 180+ days and is significantly more expensive.
Many Shopify medical device retailers focus on Class I and Class II devices specifically because the regulatory pathway is more manageable.
Step 4: Establish Quality Management Systems
The FDA expects all medical device sellers to maintain documented quality systems. This includes:
- Design documentation: Records showing how you developed the product (if you're a manufacturer)
- Manufacturing records: Documentation of production processes and quality checks
- Testing and validation: Evidence that your device performs as claimed
- Complaint handling: System for tracking and responding to customer complaints
- Corrective actions: Documentation of issues identified and how they were resolved
For Shopify stores, implement this through:
- Document management system (ShareFile, Box, or custom database)
- Adverse event tracking spreadsheet or app
- Complaint log with follow-up procedures
- Supplier quality agreements (if you're a distributor)
The FDA expects these systems to be accessible during audits. A disorganized spreadsheet looks bad; a well-documented system demonstrates professionalism and due diligence.
Step 5: Labeling and Claims Substantiation
Your product descriptions on Shopify carry regulatory weight. Here's what's required:
Mandatory labeling elements for Class II devices:
- Device name and intended use
- Manufacturer name and address
- Lot/batch number (if applicable)
- Expiration date (if applicable)
- Storage conditions
- Instructions for use
- Warnings and contraindications
- Symbols and meanings (if using standardized symbols)
Prohibited claims that trigger enforcement action:
- "Cures diabetes" or other disease cure claims
- "Approved by FDA" (never say this—the FDA doesn't approve supplements or wellness devices)
- "Clinically proven" without clinical evidence
- Overstated benefits beyond your device's intended use
Safe claims based on intended use:
- "Helps monitor blood glucose levels" (for glucose monitors)
- "Provides compression therapy for circulation support" (for compression garments)
- "Assists with mobility and walking" (for mobility aids)
Review your Shopify product descriptions with a compliance consultant. One problematic claim can trigger FDA warning letters affecting your entire store.
B2B vs. B2C: Structuring Your Shopify Store
Medical devices distribute differently based on target customer. Most successful Shopify stores operate hybrid models.
B2C (Direct-to-Consumer) Model
Best for:
- Over-the-counter devices (mobility aids, monitoring equipment, compression gear)
- Consumables and supplies (ostomy supplies, wound dressings, continuous glucose monitor supplies)
- Wellness devices (fitness trackers, sleep monitors, air quality monitors)
- Self-fitting devices (compression sleeves, arch supports, braces)
Advantages:
- Higher profit margins (no wholesaler markup)
- Direct customer relationships and feedback
- Faster decision-making
- Lower order fulfillment complexity
Challenges:
- Direct regulatory responsibility
- Customer support burden
- Marketing and acquisition costs
- Returns and warranty management
Shopify configuration for B2C:
- Enable standard payment processing
- Implement HSA/FSA card handling (discuss below)
- Create clear product education content
- Build customer support systems for complex devices
- Consider product financing options for expensive equipment
B2B (Business-to-Business) Model
Best for:
- Devices requiring professional fitting (orthotics, prosthetics, custom braces)
- High-volume consumables (hospitals, clinical settings)
- Professional-use equipment (physical therapy equipment, clinical diagnostics)
- Restricted devices (those requiring prescription or professional supervision)
Advantages:
- Larger order values
- Predictable recurring orders (consumables)
- Professional relationships and contracts
- Clearer regulatory pathways through established dealers
Challenges:
- Complex pricing structures (tiered, volume-based, contract-based)
- Extended sales cycles
- Payment terms (net 30/60/90 instead of immediate)
- Integration with procurement systems
Shopify configuration for B2B:
- Use Shopify Plus for advanced B2B features (or B2B apps like Shopify B2B Edition)
- Implement customer-specific pricing and catalogs
- Enable invoicing and payment terms
- Create customer-specific product bundles and configurations
- Build quote management workflows
- Integrate with healthcare procurement platforms
Hybrid Strategy (Recommended)
The most resilient approach combines B2B and B2C:
- B2C channel (60-70% of sales): Direct sales through your Shopify store to individuals, small clinics, and wellness practitioners
- B2B channel (30-40% of sales): Wholesale accounts with hospitals, rehab facilities, medical supply distributors
Implement this through:
- Separate Shopify sales channels (one public B2C, one B2B with access controls)
- Customer type classification in Shopify (Individual vs. Healthcare Professional)
- Tiered pricing rules based on customer segment
- Different product assortments by channel (some products B2C only, others B2B only)
This hybrid approach maximizes revenue while managing regulatory complexity—you're not putting high-risk Class III devices in a B2C storefront while still capturing retail demand.
Payment Processing: HSA, FSA, and Insurance
Medical device sales involve payment methods unknown to standard e-commerce.
HSA (Health Savings Account) and FSA (Flexible Spending Account) Payments
Approximately 43 million Americans have HSA/FSA accounts, representing $80+ billion in annual spending. These accounts can only purchase IRS-qualified medical expenses. Getting this right dramatically increases your addressable market.
How HSA/FSA works:
- Account holders receive debit cards linked to their HSA/FSA accounts
- They can use these cards like regular debit cards at eligible merchants
- At purchase, they declare the expense as medical
- Some retailers verify eligibility; others rely on the cardholder's declaration
Why HSA/FSA matters for your store:
- Every medical device sale is potentially HSA/FSA-eligible
- A $500 mobility aid becomes $200 out-of-pocket for an HSA holder (40% savings)
- Customers actively seek HSA-eligible retailers
- Including HSA/FSA eligibility is a significant competitive advantage
Implementing HSA/FSA on Shopify:
Option 1 (Basic): Enable standard card acceptance
- Accept all credit and debit cards in Shopify Payments
- Add messaging: "This product qualifies for HSA/FSA spending. HSA/FSA cards accepted."
- Benefits: No additional setup, customers self-certify
- Drawback: Higher chargeback rates from customers disputing eligibility
Option 2 (Intermediate): Partner with health payment processor
- Integrate Stripe Health or WellSky
- These processors verify HSA/FSA eligibility at checkout
- Benefits: Reduce chargebacks, build trust, improve conversion
- Drawback: Slightly higher processing fees
Option 3 (Advanced): Enable third-party verification
- Integrate with VerifyMe or similar platforms
- These verify product eligibility and customer account status
- Benefits: Maximum compliance, minimal chargeback risk
- Drawback: Most expensive, may slow checkout
For Shopify: Start with Option 2 if you're selling $500K+ in annual revenue. Option 1 is sufficient for smaller stores.
Additionally, clearly label which products qualify for HSA/FSA in Shopify:
- Add "HSA/FSA Eligible" tag to qualifying products
- Include explanation in product description
- Create a guide: "What qualifies for HSA/FSA spending?"
- Consider creating a dedicated collection for HSA-eligible products
Insurance and Reimbursement
Some medical devices are covered by insurance (Medicare, commercial plans, workers' compensation). This opens a significant revenue channel but requires setup.
How insurance reimbursement works:
- Insurance covers the cost; patient pays copay or coinsurance
- Retailer bills insurance directly (or uses clearinghouse)
- Retailer receives payment from insurance
Devices typically covered:
- Blood glucose monitors and supplies (diabetes management)
- Continuous Positive Airway Pressure (CPAP) machines (sleep apnea)
- Orthotic devices (braces, supports)
- Mobility aids (walkers, canes, wheelchairs)
- Hearing aids (some plans)
Implementation for Shopify:
For Shopify stores, full insurance billing is complex and typically requires separate systems. Instead:
- Build a resource guide on your store explaining insurance coverage. Link to Medicare's DMEPOS database showing covered devices
- Enable direct-to-insurance billing through a third-party platform (like Solstice or Byram Healthcare)
- Accept insurance claims by allowing customers to submit receipts for reimbursement (they bill insurance separately)
- Create an "Insurance Information" section on each eligible product showing:
- CPT or HCPCS code (for billing)
- Typical insurance coverage information
- Link to check coverage with their plan
- Note: "This item is typically covered by insurance. Contact your plan to verify coverage and copay amounts."
This approach keeps your Shopify store straightforward while enabling customers to pursue insurance reimbursement separately.
Product Documentation and Data Management
The FDA expects medical device retailers to maintain comprehensive product files. This isn't for your website—it's for regulatory audits and customer inquiries.
Essential Documentation
1. Premarket Submissions (if applicable)
- 510(k) summary or PMA approval letter from FDA
- Predicate device justification (for 510k)
- Clinical trial data (for Class III)
- Store these securely and provide to FDA upon request
2. Specifications and Technical Data
- Complete product specifications (materials, dimensions, weight)
- Performance data and testing results
- Shelf life and storage requirements
- Biocompatibility data (for devices with body contact)
3. Instructions for Use (IFU)
- Step-by-step usage instructions
- Warnings and contraindications
- Troubleshooting guide
- Available in customer's primary language
- PDF version available on your Shopify store (in a customer resources section)
4. Quality Documentation
- Manufacturing process documentation
- Quality control procedures and test data
- Supplier quality agreements (for components)
- Change logs for design modifications
5. Safety and Adverse Events
- Adverse event reporting system
- Complaint log and investigation records
- Corrective actions implemented
- Trend analysis of complaints
6. Traceability Records
- Lot/batch tracking by customer
- Supplier information and lot traceability
- Records allowing rapid recall if needed
7. Regulatory History
- FDA registration and listing documents
- Correspondence with FDA
- Warning letter responses (if applicable)
- Inspection reports and responses
Building Your Documentation System
For Shopify stores, implement through:
-
Cloud-based document management (Box, Dropbox, Sharepoint)
- Organize by product category
- Version control for updates
- Access controls (who can view/edit)
- Audit trail of all changes
-
Spreadsheet-based tracking
- Adverse event log (date, severity, action taken)
- Complaint tracking (received, investigated, resolved)
- Sales tracking (by lot/batch, for recall traceability)
-
Supplier management
- Supplier agreements and quality terms
- Certificates of conformance for components
- Change notifications for ingredients/materials
-
Audit readiness
- Annual documentation review
- Gaps assessment and remediation
- Practice FDA simulations
- Legal review of documentation
The goal: If the FDA showed up next week, you could produce complete files demonstrating compliance within 24 hours.
Building Your Shopify Medical Device Store
With regulatory foundations established, here's how to structure your Shopify store:
Store Setup Essentials
1. Product Setup
- Complete product titles including device classification (e.g., "Class II Blood Pressure Monitor - Digital Automatic")
- Comprehensive descriptions including:
- Intended use (regulatory language)
- Key features and benefits (marketing language)
- Specifications and technical data
- Instructions for use (link to PDF)
- HSA/FSA eligibility status
- Insurance coverage information (if applicable)
- Contraindications and warnings
- Product images showing:
- Device itself from multiple angles
- Packaging and labels
- Instructions and documentation included
- Size comparison (for scale context)
- Detailed specifications using Shopify metafields:
- Medical Device Class
- FDA Classification
- Device Listing Number
- Premarket Submission Number (if applicable)
- HCPCS/CPT Code (for billable items)
2. Collections and Navigation
- Organize by device class or clinical use
- "Mobility and Accessibility"
- "Monitoring and Diagnostics"
- "Wound Care and Ostomy"
- "Orthopedic Support"
- Separate collections for B2B and B2C (if hybrid model)
- HSA/FSA eligible collection
3. Customer Education Content
- Create a dedicated blog section covering:
- "Choosing the right mobility aid for your needs"
- "How to use [specific device]"
- "Understanding insurance coverage for medical devices"
- "HSA and FSA eligibility for medical devices"
- "Quality and safety certifications explained"
- Link relevant blog articles to product pages
- Create comparison guides for similar products
4. Customer Support System
- Implement live chat for product questions
- Create comprehensive FAQ sections on key products
- Build support portal for existing customers to access documentation
- Include phone support for complex inquiries
- Implement ticket system for complaints and adverse event reporting
5. Compliance and Legal Pages
- Create distinct pages (not just standard Shopify pages):
- "Medical Device Disclaimer" explaining regulatory status
- "Product Safety Information" linking to safety data
- "Adverse Event Reporting" (explain how customers can report issues)
- "Quality and Compliance" (optional transparency about your systems)
- "Returns and Warranty" (account for device-specific restrictions)
6. Checkout Optimization
- Enable Shopify Payments or third-party payment processor (for HSA/FSA)
- Add payment options (credit card, HSA/FSA card, insurance billing option)
- Create checkout notes field asking:
- Intended use (home use vs. professional use)
- Clinical condition (for patient education purposes)
- Fit and sizing preferences (for custom devices)
- Implement GDPR/privacy compliance for health data
Security and Privacy Considerations
Medical devices may involve Protected Health Information (PHI). Implement:
- HIPAA compliance if you're storing patient health information
- Business Associate Agreements (BAAs) with Shopify
- Encryption of customer data at rest and in transit
- Access controls and audit logs
- Incident response plan for data breaches
- Data retention policies (how long you keep customer information)
- Privacy policy explaining health data handling
- GDPR compliance for EU customers
Marketing Your Medical Device Store
Medical device marketing differs from mainstream e-commerce due to regulatory constraints.
What You Can and Cannot Claim
Prohibited:
- "Cures," "treats," or "prevents" disease (unless you have specific FDA approval)
- "Approved by the FDA" (the FDA doesn't approve medical devices in that sense—they clear them)
- "Better than prescription" or "replaces medication"
- Clinical outcomes without substantiation
Permitted:
- Use the device's intended use exactly as stated in FDA submissions
- "Helps manage symptoms of [condition]"
- "Assists with [specific function]" (e.g., "assists with mobility")
- General wellness claims (energy, comfort, convenience)
- Comparative claims with clinical substantiation
- Testimonials (with disclaimers that results vary)
Content Marketing Strategies
Educational content performs well because medical device customers need information:
- "Complete guide to selecting a mobility aid"
- "How to fit a compression sleeve correctly"
- "Understanding your blood glucose monitor: a step-by-step guide"
- "Caring for your orthotic device"
Professional credibility builds trust:
- Write content with qualified healthcare professionals
- Cite clinical studies supporting benefits
- Include disclaimers about FDA classification
- Build relationships with healthcare providers who can recommend your products
Audience targeting:
- Target healthcare professionals (doctors, physical therapists, nurses)
- Target caregivers searching for solutions for aging parents
- Target chronic disease communities (diabetes, sleep apnea, arthritis)
- Use health-specific keywords with compliance-safe language
SEO for medical devices:
- Target long-tail keywords: "Best blood pressure monitor for home use," not "Blood pressure monitor"
- Create comparison content: "Mobility aid buyer's guide" (searches from decision-phase customers)
- Build local content: "Where to buy mobility aids in [city]"
- Earn backlinks from healthcare sites and patient communities
Case Study: Successful Medical Device Shopify Stores
Several brands have successfully scaled medical device sales on Shopify. Common patterns:
- Vitruvi (essential oil diffusers for wellness) built educational content about health benefits and reached $10M+ ARR
- Kindara (fertility tracking devices) combined product sales with content about cycle tracking and earned trust through educational positioning
- Noom (health tracking) integrated behavioral change with device recommendations
- Theragun (percussion massage devices) focused on recovery and athletic performance—avoiding disease claims while capturing wellness market
Each succeeded by:
- Mastering their FDA classification and compliance requirements
- Building educational content customers actually valued
- Positioning products as solutions to real problems (not disease claims)
- Creating professional, trustworthy brand positioning
- Investing in customer education and support
Shopify Platform for Medical Devices: Strengths and Limitations
Why Shopify Works for Medical Devices
- Compliance-neutral platform: Shopify doesn't restrict medical device categories (unlike Amazon or eBay)
- Customizable product data: Store complex specifications and regulatory information in metafields
- Payment flexibility: Accept multiple payment types (cards, HSA/FSA, insurance claims)
- Content management: Create detailed product pages and educational content
- Scalability: Grow from $100K to $10M+ in revenue without platform limitations
- Cost-effective: No platform-specific compliance fees (you only pay for apps you choose)
- Integration ecosystem: Connect specialized medical device apps, compliance tools, and shipping systems
Shopify's Limitations for Medical Devices
- No built-in FDA documentation management: You must implement external systems
- No premarket submission workflows: Manage these outside Shopify
- No automated adverse event reporting: Build this yourself or use third-party apps
- Limited HIPAA compliance features: Requires careful configuration and BAAs
- No insurance billing integration: Use third-party platforms for reimbursement processing
- No prescription verification: If selling prescription devices, verify independently
- Standard payment processing: May have higher fraud flags for health products
Bottom line: Shopify is excellent for B2C medical device retail and many B2B applications. For highly regulated Class III devices, complex B2B with insurance billing, or devices requiring prescription verification, consider specialized platforms like Verifone Healthcare, NextGen, or custom solutions—though many medical device companies use Shopify as their B2C complement to these systems.
Building a Sustainable Compliance Program
Launching compliant is important, but maintaining compliance long-term determines success.
Annual Compliance Calendar
January:
- Review adverse event reports from previous year
- Assess for product trends requiring corrective actions
- Plan quality audits
April:
- Conduct internal FDA audit of documentation
- Review and update quality procedures
- Assess supplier compliance
August:
- Review customer complaints and implement improvements
- Update product labeling if regulatory guidance changed
- Train staff on compliance requirements
October:
- Prepare FDA registration renewal (due before December 31)
- Compile annual adverse event summary
- Plan next year's compliance initiatives
Ongoing:
- Adverse event log maintained every transaction
- Customer complaint tracking and investigation
- Supplier monitoring
- Product update documentation
Budget Allocation for Compliance
For a $1-2M medical device store, allocate:
- 20-30% of legal budget to compliance (not just contracts)
- 5-10% of operations to documentation management and training
- 1-2% of revenue to compliance app subscriptions and third-party services
This isn't overhead—it's insurance against FDA enforcement action, which can cost $100K-$1M+ to resolve.
Getting Started: Roadmap to Launch
Month 1: Regulatory Foundation
- Determine your regulatory status (manufacturer, distributor, etc.)
- Classify your products with FDA
- Register your company and list your products
- Identify premarket submission requirements (510k, PMA, or general controls)
Month 2: Compliance Setup
- Gather all regulatory documentation
- Establish quality management system
- Create adverse event tracking system
- Build product documentation repository
- Document product specifications and intended use
Month 3: Shopify Store Build
- Set up Shopify store and domain
- Create product pages with complete information
- Set up payment processing (cards, HSA/FSA)
- Create customer support system
- Build compliance pages
Month 4: Launch Preparation
- Review all product descriptions for compliance
- Conduct internal compliance audit
- Staff training on policies and procedures
- Create customer education content
- Plan launch marketing
Month 5: Launch and Optimize
- Soft launch to existing customer base
- Monitor for compliance issues
- Gather customer feedback
- Optimize conversion and support processes
- Full market launch with marketing campaign
Key Takeaways
- Shopify is suitable for most medical device retailers, particularly those selling Class I and Class II devices directly to consumers or healthcare professionals
- FDA compliance is mandatory, not optional, and requires documented systems for registration, premarket submissions, quality management, and adverse event reporting
- B2B and B2C models require different Shopify configurations, but hybrid approaches work well
- HSA/FSA payment acceptance is a competitive advantage that dramatically increases addressable market and conversion rates
- Product documentation and compliance systems are as important as the store itself, creating defensibility against FDA enforcement and customer disputes
- Marketing medical devices requires restraint, avoiding disease claims while creating educational content that builds trust
The medical device market represents massive opportunity for e-commerce sellers. Start with regulatory foundations, build compliance systems before launch, and scale confidently knowing you're operating within regulatory requirements.
Ready to Launch Your Medical Device Store?
If you're navigating the complexity of launching a compliant medical device e-commerce business, we can help. Our e-commerce specialists have worked with health equipment retailers, medical supply distributors, and device manufacturers to build compliant, profitable Shopify stores.
Start with a free audit of your medical device e-commerce strategy—we'll review your current approach and identify compliance gaps and growth opportunities.
Or schedule a consultation with our healthcare e-commerce team to discuss your specific situation and get personalized guidance.
Additional Resources
For deeper research on medical device e-commerce:
- FDA Guidance Documents: Search FDA's premarket guidance
- FURLS Registration System: FDA's Unified Registration and Listing System
- HSA Eligible Products: IRS Publication 502 - Medical and Dental Expenses
- Insurance Coverage: Medicare DMEPOS Search
- Shopify Medical Device Apps: Look for compliance, documentation, and HSA/FSA processing apps in Shopify App Store
Ready to scale your medical device business?
Shopify is one of the best platforms for launching your medical device store. If you're ready to build, start your free trial today and access tools for product management, payment processing, and customer communication.
Not sure if Shopify is right for your medical device business? Get a personalized audit of your e-commerce strategy—we'll assess your current approach, identify compliance opportunities, and recommend the right platform and structure for your situation.
Your next step: Contact us to discuss your medical device e-commerce goals. We'll help you navigate regulatory requirements and build a store that drives growth without cutting corners on compliance.
Want to explore how e-commerce platforms are evolving for specialized industries? Check out Shopify's full capabilities for healthcare and wellness retailers, or read more guides on niche e-commerce strategies.