Understanding prescription requirements for contact lenses is critical for brand owners selling internationally. Regulations vary significantly by country, and non-compliance can result in fines, product seizures, or banned sales.

What Is a Contact Lens Prescription?

A contact lens prescription includes specific parameters that ensure proper fit and safety:

• Power (PWR/DIA): Refractive correction in diopters
• Base Curve (BC): Curvature of the lens back surface
• Diameter (DIA): Total lens width
• Brand/Material: Specific lens type approved
• Expiration date: When prescription must be renewed

Regional Requirements

🇺🇸 United States (FDA)

Classification: Class II or Class III medical device

• Prescription required: Yes, for all contact lenses including cosmetic
• Prescription validity: 1-2 years (varies by state)
• Seller requirements: Must verify prescription before sale
• FDA registration: Required for manufacturers and importers
• 510(k) clearance: Required for new lens materials

🇪🇺 European Union (CE)

Classification: Class IIa or Class IIb medical device

• Prescription required: Varies by member state
• CE marking: Mandatory for all EU sales
• Authorized Representative: Required for non-EU manufacturers
• Technical documentation: Must be maintained for 10 years
• UDI (Unique Device Identification): Required since 2021

🇬🇧 United Kingdom (Post-Brexit)

Classification: Class IIa or Class IIb medical device

• Prescription required: Yes, enforced by optometrists
• UKCA marking: Required (transition from CE ongoing)
• Responsible Person: Required for non-UK manufacturers
• MHRA registration: Required before placing on market

🇨🇦 Canada (Health Canada)

Classification: Class II or Class III medical device

• Prescription required: Yes, for all contact lenses
• Medical Device License: Required for Class III
• Establishment License: Required for importers/distributors
• ISO 13485: Strongly recommended

🇦🇺 Australia (TGA)

Classification: Class IIa or Class IIb medical device

• Prescription required: Yes, enforced
• ARTG inclusion: Required before sale
• Sponsor required: Australian-based sponsor mandatory
• Advertising restrictions: Cannot advertise to public

🇯🇵 Japan (PMDA)

Classification: Class II or Class III medical device

• Prescription required: Yes, strictly enforced
• Marketing Authorization: Required
• Local MAH: Marketing Authorization Holder must be in Japan
• GQP/GVP: Quality and vigilance standards required

🇰🇷 South Korea (MFDS)

Classification: Class II or Class III medical device

• Prescription required: Yes
• KFDA approval: Required before import
• Local importer: Must be licensed
• Korean labeling: Mandatory

🇸🇬 Singapore (HSA)

Classification: Class B or Class C medical device

• Prescription required: Yes
• Product Registration: Required
• Local Registrant: Required
• ASEAN CSDT: Common submission dossier accepted

🇦🇪 UAE / GCC (MOHAP)

Classification: Medical device

• Prescription required: Varies by emirate
• MOHAP registration: Required
• CE/FDA: Often accepted as supporting documentation
• Arabic labeling: Required

For Brand Owners: Compliance Checklist

Before Launching

1. Identify target markets
2. Research specific requirements per country
3. Ensure manufacturer has appropriate certifications
4. Obtain necessary import/distribution licenses
5. Prepare technical documentation
6. Plan for local representatives if required

Packaging Requirements

• Language requirements per market
• Batch/lot number traceability
• Expiration date format
• Storage conditions
• Manufacturer information
• Warning statements

Ongoing Compliance

• Adverse event reporting
• Product recalls (if needed)
• License renewals
• Documentation updates
• Regulatory change monitoring

Common Mistakes to Avoid

❌ Assuming One Certification Covers All

CE marking does not equal FDA approval. Each market has separate requirements.

❌ Selling Without Proper Registration

Importing medical devices without registration can result in customs seizure.

❌ Ignoring Local Representative Requirements

Many countries require a local entity to be responsible for products.

❌ Inadequate Documentation

Technical files must be maintained and available for inspection.

At MIOMI Optical

We support compliance with:

• FDA Registration: Facility registered, products listed
• CE Marking: Full technical documentation available
• ISO 13485: Certified quality management system
• Documentation Package: COA, COO, specifications, safety data
• Multi-market Experience: Exporting to 50+ countries

Contact us: eye@miomi.cc | miomicon.com