2026-09-21 · KeXinMaterials 編集チーム
医療ケース FDA CE コンプライアンス B2B 調達:AED、救急、除細動器 (2026)
医療ケースは生命を救う機器を保護します — AED、除細動器、救急キット、医薬品、診断機器。FDA / CE / ISO 13485 コンプライアンスは交渉の余地がありません。これが 2026 B2B 調達ガイドです。
なぜ医療ケースのコンプライアンスは別カテゴリなのか
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 互換性声明
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.
EU 医療市場向け CE マーキング
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 品質管理
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.
材料互換性:PP vs PE vs PU フォーム
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.
医療用途別ケース設計
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、リードタイム、価格
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.
なぜ KeXinMaterials を医療ケースに選ぶのか
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.
重要なポイント
- 医療ケース:AED / 除細動器 / 救急 / 医薬品 / 診断 — 5+ カテゴリ
- FDA 互換性声明を SKU ごとに(FDA 21 CFR 177.1520 食品接触コンプライアンス)
- EU MDR 2017/745 + EUDAMED 登録に基づく CE マーキング、EU 医療市場向け
- ISO 13485 認証進行中;医療 SKU の ISO 13485 準拠 QMS がアクティブ
- 素材:PP シェル + PE フォーム(FDA 互換)/ EVA プレミアム / PU ライナー付き
よくある質問
医療ケースの FDA 互換性声明とは何ですか?
FDA 互換性声明は以下を宣言します:ケース材料組成、医療機器内容物と接触する可能性のある抽出可能 / 溶出可能な物質の不存在、該当する場合の FDA 21 CFR(連邦規則集)食品接触材料へのコンプライアンス、ラテックスの不存在。ほとんどの医療機器製造業者はケースサプライヤーから SKU ごとの互換性声明を要求します。KeXinMaterials では、医療 SKU ごとに FDA 互換性声明を発行しています。
私の医療ケースは EU 市場向け CE マーキングが必要ですか?
はい。EU MDR 2017/745(医療機器規則)は医療機器と付属品を規制します。医療機器を輸送するために使用される保護ケースは付属品として分類され、MDR に基づく CE マーキングが必要になる場合があります。医療ケースの CE マーキングプロセス:MDR 附属書 VIII に従って分類(通常はクラス I)、附属書 II に従って技術文書を作成、適合宣言書(DoC)を発行、CE マークを貼付、EUDAMED データベースに登録。
ISO 13485 とは何ですか?また私のケース工場は必要ですか?
ISO 13485 は医療機器品質マネジメントシステム規格です。組織が医療機器および関連するサービスを一貫して顧客および適用される規制要件を満たす能力を提供することを実証する必要がある QMS の要件を指定します。医療機器 OEM にサービスを提供する保護ケース製造業者にとって、ISO 13485 認証は工場が医療グレード QMS のもとで運営していることを示しています — 文書管理、トレーサビリティ、是正予防処置(CAPA)、市販後監視。KeXinMaterials では、ISO 9001:2015 に加えて医療 SKU のための ISO 13485 準拠手順で運営しています。
医療ケースに FDA 互換性のある素材はどれですか?
PP(ポリプロピレン)は FDA 21 CFR 177.1520 に食品接触について準拠しています。優れた耐薬品性。PE(ポリエチレン)も FDA 21 CFR 177.1520 に準拠。PU フォーム(ポリウレタン)は医療用途には防水ライナーが必要;添加剤パッケージ付きの FDA 互換 PU が利用可能です。PE フォーム(閉孔ポリエチレン)は防水、耐薬品性、FDA 互換。EVA フォーム(エチレン-酢酸ビニル)は高反発、閉孔、FDA 互換。KeXinMaterials では、標準医療ケース SKU として PP シェル + PE フォームを在庫しています。
医療ケースカスタム OEM の MOQ は?
Tier 1(在庫医療 SKU):MOQ 50-100 ケース、USD 130-220/個、15-25 日生産。FDA 互換性声明を含む。Tier 2(カスタム医療 OEM):MOQ 100-300 ケース、USD 180-350/個(ケース + カスタムフォーム + FDA 声明)、30-45 日生産。CE 技術文書発行。Tier 3(新規医療金型):MOQ 1,000+ ケースを 12-24 ヶ月で償却、償却後 USD 150-280/個、60-90 日金型 + 30-45 日生産。完全な MDR 技術ファイル。
B2B バイヤーはどの医療ケース認証を検証すべきですか?
SKU ごとの FDA 互換性声明(FDA 21 CFR 177.1520 食品接触コンプライアンス)。EU 市場向け EUDAMED 登録付きの EU MDR 2017/745 に基づく CE マーキング。医療グレードサプライチェーン向けの ISO 13485 認証または ISO 13485 準拠 QMS。ラテックスフリー宣言。材料トレーサビリティ(PP / PE フォームロット番号)。KeXinMaterials では、医療 SKU プログラム向けに FDA 互換性声明、CE 文書、ISO 13485 準拠 QMS を提供しています。