| Knee, hip, wrist, or hand braces |
ISO 13485 QMS
Batch specifications
Material traceability
Confirm dimensional tolerances, stitching or molding consistency, fastener strength, labeling control, and documented final inspection.
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Assess skin-contact materials under the applicable biological-evaluation process, including ISO 10993 where relevant. Check pressure points, circulation risks, latex content, cleaning instructions, and correct sizing.
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Look for controlled clinical studies or systematic reviews using validated outcomes such as pain scales, function scores, walking ability, or joint-specific measures such as WOMAC or KOOS. Mechanical support alone does not prove clinical benefit.
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Verify the product’s medical-device classification in the destination market, importer responsibilities, technical documentation, complaint handling, and post-market surveillance arrangements.
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Unverified “medical-grade” claims
No size chart
No material disclosure
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| Orthotic insoles and footwear-support products |
Require material composition, compression or durability data, production tolerances, and consistency testing between lots. Independent testing is preferable for load-bearing components.
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Evaluate slip resistance, edge finishing, arch-support pressure, moisture management, odor-control claims, and compatibility with the intended footwear. Users with diabetes or reduced sensation may require professional assessment.
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Evidence should identify the target condition and outcome. Studies should report participant characteristics, follow-up duration, comparator treatment, and adverse events rather than relying only on comfort surveys.
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Compare samples from different production lots, confirm packaging protection during international transport, and require documented replacement procedures for dimensional or material defects.
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Universal fit claims
No wear-life data
Benefits extrapolated from unrelated conditions
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| Heat, cold, and compression products |
Check temperature-control performance, insulation or cooling duration, seam integrity, pressure consistency, and electrical safety documentation for powered products.
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Confirm burn-prevention instructions, maximum contact time, skin inspection guidance, contraindications, battery or charger safety, and protection against excessive compression.
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Prefer trials that measure pain relief, stiffness, or function with a defined comparator and follow-up period. Short-term comfort results should not be presented as long-term disease modification.
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Verify conformity requirements for electrical products in each destination market and confirm that multilingual instructions include emergency and misuse warnings.
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No temperature or pressure limits
Missing electrical documentation
“Regenerates cartilage” claims
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| Exercise, mobility, and rehabilitation aids |
Evaluate load ratings, fatigue testing, grip performance, stability, material durability, and inspection records. Product specifications should match the intended user weight and activity level.
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Review tipping, slipping, pinch-point, fall, and assembly risks. Instructions should include setup, maintenance, inspection intervals, and safe-use limits.
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Effectiveness should be judged by functional outcomes such as walking distance, balance, strength, range of motion, or activity performance, not only by product satisfaction.
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Require user manuals, spare-part availability, packaging drop-test evidence where appropriate, and a documented process for handling safety complaints across borders.
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Unclear load capacity
No assembly instructions
Safety claims without testing records
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| Oral supplements marketed for joint support |
Require a full ingredient list, declared quantities per serving, lot identification, expiry date, manufacturing controls, and a certificate of analysis from a qualified laboratory for identity, potency, contaminants, and microbiological quality.
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Assess allergen statements, interactions, contraindications, heavy-metal and microbial testing, adulteration risk, and the legal status of each ingredient in the destination market. “Natural” does not mean risk-free.
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Give greater weight to randomized controlled trials of the same ingredient, dose, formulation, and target population. Evidence for one formulation should not automatically be transferred to another.
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Verify applicable food or supplement regulations, good manufacturing practice controls, customs documentation, stability data for the shipping climate, and permitted health claims in the destination country.
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Disease-cure claims
Proprietary blend without quantities
No independent testing
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| Topical creams, gels, and patches |
Check active-ingredient identity and concentration, preservative effectiveness, pH, viscosity, stability, packaging compatibility, and lot-release testing.
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Review skin-irritation and sensitization data, directions for use, contact-time limits, storage conditions, and warnings about broken skin or simultaneous use with other topical products.
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Look for human studies measuring pain or function with a suitable placebo or active comparator. Claims should match the regulatory category and approved labeling in the target market.
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Confirm whether the product is regulated as a cosmetic, medicine, or medical device in each jurisdiction. Check language requirements, tamper evidence, and temperature exposure during transit.
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Unlisted active ingredients
No stability information
Instant or permanent cure claims
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| Digital pain-management and rehabilitation tools |
Evaluate software version control, cybersecurity procedures, data integrity, usability testing, and documented change management. Hardware should have traceable serial or lot records.
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Review privacy compliance, electrical safety where applicable, user-screening criteria, contraindications, emergency stop functions, and procedures for responding to abnormal symptoms.
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Prefer prospective studies that report adherence, pain, function, quality of life, and adverse events. Engagement metrics alone are not proof of clinical effectiveness.
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Confirm data-hosting locations, cross-border data-transfer requirements, technical support, regulatory classification, subscription continuity, and access to user data and reports.
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No privacy policy
Uncontrolled software updates
AI claims without validation
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| Supplier and factory qualification |
Request quality certificates, audit summaries, process-flow diagrams, calibration records, training records, nonconformance procedures, and corrective-action history. ISO 13485 certification is relevant to many medical-device manufacturers but does not by itself prove product effectiveness.
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Confirm a risk-management process consistent with ISO 14971 for applicable medical devices, documented complaint handling, recall capability, and traceability from raw material to finished product.
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Separate manufacturing capability from clinical proof. A reliable factory can produce consistently, but effectiveness still requires appropriate clinical or performance evidence for the specific product.
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Use pre-shipment inspection, approved samples, lot acceptance criteria, supplier audits, change-notification clauses, and independent laboratory testing for high-risk characteristics.
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Certificate cannot be verified
Refusal to provide test reports
Uncontrolled subcontracting
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| Evidence and purchasing decision |
Use a written specification covering materials, dimensions, performance limits, labeling, packaging, acceptance criteria, and record-retention requirements.
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Apply a documented risk score based on severity, probability, exposure, user population, and reversibility of harm. Higher-risk products require stronger verification and clinical oversight.
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Rank evidence by relevance: systematic reviews and well-designed randomized trials generally provide stronger comparative evidence than testimonials, laboratory demonstrations, or uncontrolled before-and-after reports.
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Compare total landed cost, regulatory obligations, shipping conditions, lead time, minimum order quantity, warranty terms, replacement availability, and post-market support—not only the unit price.
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Lowest price used as the main criterion
Testimonials treated as clinical proof
No recall or complaint process
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