2026-09-21 · KeXinMaterials Editorial Team
Medical Case FDA CE Compliance for B2B Procurement: AED, First Aid, Defibrillator (2026)
Medical cases protect life-saving equipment — AEDs, defibrillators, first aid kits, pharmaceuticals, diagnostics. Compliance with FDA / CE / ISO 13485 is non-negotiable. Here is the 2026 B2B procurement guide.
Why Medical Case Compliance Is a Separate Category
Medical cases carry devices that directly affect patient outcomes. Compliance is regulated, not optional.
Medical cases transport AEDs, defibrillators, first aid kits, intubation kits, oxygen masks, pharmaceuticals, and diagnostic equipment. Damage or contamination of these devices can directly harm patients.
Regulatory frameworks: FDA (US market), CE (EU market), Health Canada, TGA (Australia), PMDA (Japan), NMPA (China). Each requires specific material compatibility and traceability documentation.
For B2B buyers, medical case compliance is not a "nice to have" — it is a regulatory requirement. Non-compliant cases risk medical device recalls, FDA warning letters, and criminal liability.
FDA Compatibility Statement
The FDA does not certify protective cases directly. The case manufacturer provides a compatibility statement that the device manufacturer incorporates into their FDA submission.
FDA compatibility statement declares: case material composition, absence of extractable / leachable substances that could contact medical device contents, compliance with FDA 21 CFR (Code of Federal Regulations) for food-contact materials where applicable, and absence of latex (for latex-allergic patients).
Most medical device manufacturers require a per-SKU compatibility statement from the case supplier. The statement covers shell material (PP / PE / ABS / PC), foam (PU / PE / EVA), and any hardware (latches, hinges, gaskets).
At KeXinMaterials we provide FDA compatibility statement per medical SKU. Standard SKUs pre-cleared. Custom OEM statements issued within 7 days of sample approval.
CE Marking for EU Medical Markets
CE marking is mandatory for protective cases used in EU medical applications. The case itself may fall under the Medical Device Regulation (MDR) or be considered an accessory.
EU MDR 2017/745 (Medical Device Regulation) governs medical devices and accessories. A protective case used to transport a medical device may be classified as an accessory, requiring CE marking under MDR.
CE marking process for medical case: (1) Classify the case per MDR Annex VIII — typically Class I (low risk) accessory. (2) Compile technical documentation per Annex II. (3) Issue Declaration of Conformity (DoC). (4) Apply CE mark. (5) Register with EUDAMED database for medical device traceability.
For B2B buyers sourcing CE-marked medical cases, request the DoC and the technical documentation summary. Verify the case is registered with EUDAMED. CE marking without registration is non-compliant.
At KeXinMaterials we maintain CE technical documentation for our medical case SKUs. DoC + EUDAMED registration available on request. 5-7 day lead time for DoC issuance.
ISO 13485 Quality Management
ISO 13485 is the medical device quality management standard. Case manufacturers serving medical device OEMs should hold ISO 13485 certification.
ISO 13485 specifies requirements for quality management systems where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
For protective case manufacturers serving medical device OEMs, ISO 13485 certification indicates the factory operates under medical-grade QMS — document control, traceability, CAPA (Corrective and Preventive Action), and post-market surveillance.
At KeXinMaterials we operate under ISO 9001:2015 (general QMS) plus ISO 13485-aligned quality procedures for medical SKU lines. Full ISO 13485 certification is a 12-month project (not yet certified as of 2026-09). For medical device programmes requiring ISO 13485, we partner with ISO 13485-certified case manufacturers in our supply chain.
Material Compatibility: PP vs PE vs PU Foam
Medical cases require materials compatible with pharmaceutical and biological contact. Three options dominate.
PP (Polypropylene): FDA 21 CFR 177.1520 compliant for food contact. Good chemical resistance. Cost USD 1.80-2.50/kg. Standard for medical case shells.
PE (Polyethylene): FDA 21 CFR 177.1520 compliant. Slightly softer than PP. Good chemical resistance. Common for medical case shells and foam.
PU foam (Polyurethane): open-cell structure absorbs liquids. For medical use, must be sealed in waterproof liner or replaced with closed-cell PE foam. FDA-compatible PU available with additive package.
PE foam (closed-cell Polyethylene): waterproof, chemical-resistant, FDA-compatible. Standard for medical case foam interiors. Density 28-45 kg/m³.
EVA foam (Ethylene-Vinyl Acetate): high-rebound, closed-cell, FDA-compatible. Used for premium medical device interiors (defibrillator, ultrasound).
At KeXinMaterials we stock PP shell + PE foam as standard medical case SKU. PU available with waterproof liner. EVA on request for premium medical SKUs.
Case Designs by Medical Application
Medical cases are designed for specific applications. The case geometry, foam cutouts, and accessories vary significantly.
- AED Case (Automated External Defibrillator): Compact size 450x350x180mm. Foam cutouts for AED unit, 2 spare pads, 1 spare electrodes, scissors, razor, towel. IP65 minimum for outdoor placement. Pressure-equalisation valve.
- Defibrillator Case (hospital / EMS): Larger size 600x450x250mm. Foam cutouts for monitor / defibrillator, paddles or pads, ECG cables, SpO2 sensor, blood pressure cuff, batteries.
- First Aid Kit Case: Compact 350x250x150mm. Removable tray dividers for bandages, gauze, antiseptic, gloves, instruments. IP54 minimum.
- Pharma Transport Case: Insulated 600x450x300mm. Temperature-stable 2-8°C for 12-24 hours (with cold pack). Foam cutouts for vials, ampoules, syringes. Cold-chain validated.
- Diagnostic Device Case: Custom size. Foam cutouts for specific instruments (glucometer, ultrasound, oximeter, laryngoscope). Soft-touch interior lining.
- Intubation / Airway Kit Case: Compact 400x300x150mm. Foam cutouts for laryngoscope, blades, endotracheal tubes, syringes, bougie, suction.
MOQ, Lead Time, Pricing
Medical cases fall into three pricing tiers. Match tier to programme size.
Tier 1 (Stock medical SKU): MOQ 50-100 cases, USD 130-220/unit, 15-25 days production. FDA compatibility statement included. CE documentation available on request.
Tier 2 (Custom OEM medical): MOQ 100-300 cases, USD 180-350/unit (case + custom foam + FDA statement), 30-45 days production. CE technical documentation issued.
Tier 3 (New mould medical): MOQ 1,000+ cases amortised over 12-24 months, USD 150-280/unit post-amortisation, 60-90 days mould + 30-45 days production. Full MDR technical file.
Sample fee: USD 200-500 stock + foam, USD 500-1,500 new mould. Refundable against order ≥ 1,000 pieces.
Why Choose KeXinMaterials for Medical Cases
KeXinMaterials operates 60+ injection machines in a 13,000 m² facility since 2014. FDA compatibility statements per medical SKU. CE documentation available. ISO 13485-aligned QMS for medical SKUs.
Material: PP shell (FDA 21 CFR 177.1520 compliant), PE foam (closed-cell, waterproof, FDA-compatible). EVA available on request. PU available with waterproof liner.
Certifications: ISO 9001:2015, FDA compatibility statement per medical SKU, CE documentation on request, REACH compliance for EU export. Per-lot batch test certificate.
Medical SKU range: AED case, defibrillator case, first aid kit case, pharma transport case, diagnostic device case, intubation kit case. 50-100 piece MOQ for stock. Custom OEM at 100-300 pieces.
Trade terms: EXW Shenzhen / FOB Shenzhen / FOB Ningbo. No DDP, no EU warehouse, no US warehouse. Every shipment direct from our 13,000 m² Guangdong facility.
Key Takeaways
- Medical cases: AED / defibrillator / first aid / pharma / diagnostic — 5+ categories
- FDA compatibility statement per SKU (FDA 21 CFR 177.1520 food-contact compliance)
- CE marking under EU MDR 2017/745 + EUDAMED registration for EU medical market
- ISO 13485 certification in progress; ISO 13485-aligned QMS active for medical SKUs
- Materials: PP shell + PE foam (FDA-compatible) / EVA premium / PU with liner
FAQ
What is FDA compatibility statement for a medical case?
FDA compatibility statement declares: case material composition, absence of extractable / leachable substances that could contact medical device contents, compliance with FDA 21 CFR (Code of Federal Regulations) for food-contact materials where applicable, and absence of latex. Most medical device manufacturers require a per-SKU compatibility statement from the case supplier. The statement covers shell material (PP / PE / ABS / PC), foam (PU / PE / EVA), and any hardware. At KeXinMaterials, FDA compatibility statement is issued per medical SKU.
Does my medical case need CE marking for EU market?
Yes. EU MDR 2017/745 (Medical Device Regulation) governs medical devices and accessories. A protective case used to transport a medical device may be classified as an accessory, requiring CE marking under MDR. CE marking process for medical case: classify per MDR Annex VIII (typically Class I), compile technical documentation per Annex II, issue Declaration of Conformity (DoC), apply CE mark, register with EUDAMED database. For B2B buyers, request the DoC and verify EUDAMED registration.
What is ISO 13485 and does my case factory need it?
ISO 13485 is the medical device quality management standard. It specifies requirements for QMS where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. For protective case manufacturers serving medical device OEMs, ISO 13485 certification indicates the factory operates under medical-grade QMS — document control, traceability, CAPA, post-market surveillance. At KeXinMaterials we operate under ISO 9001:2015 plus ISO 13485-aligned procedures for medical SKUs.
What materials are FDA-compatible for medical cases?
PP (Polypropylene) is FDA 21 CFR 177.1520 compliant for food contact. Good chemical resistance. PE (Polyethylene) is also FDA 21 CFR 177.1520 compliant. PU foam (Polyurethane) requires waterproof liner for medical use; FDA-compatible PU available with additive package. PE foam (closed-cell Polyethylene) is waterproof, chemical-resistant, FDA-compatible. EVA foam (Ethylene-Vinyl Acetate) is high-rebound, closed-cell, FDA-compatible. At KeXinMaterials we stock PP shell + PE foam as standard medical case SKU.
What is the MOQ for medical case custom OEM?
Tier 1 (Stock medical SKU): MOQ 50-100 cases, USD 130-220/unit, 15-25 days production. FDA compatibility statement included. Tier 2 (Custom OEM medical): MOQ 100-300 cases, USD 180-350/unit (case + custom foam + FDA statement), 30-45 days production. CE technical documentation issued. Tier 3 (New mould medical): MOQ 1,000+ cases amortised over 12-24 months, USD 150-280/unit post-amortisation, 60-90 days mould + 30-45 days production. Full MDR technical file.
What medical case certifications should B2B buyers verify?
FDA compatibility statement per SKU (FDA 21 CFR 177.1520 food-contact compliance). CE marking under EU MDR 2017/745 with EUDAMED registration for EU market. ISO 13485 certification or ISO 13485-aligned QMS for medical-grade supply chain. Latex-free declaration. Material traceability (PP / PE foam lot numbers). At KeXinMaterials we provide FDA compatibility statement, CE documentation, and ISO 13485-aligned QMS for medical SKU programmes.