医療機器試験・検査・認証アウトソーシングの世界市場：市場規模・シェア・動向分析 (サービス別、機器クラス別、最終用途別、地域別)、セグメント別予測 (2025年～2030年)

医療機器試験・検査・認証アウトソーシング市場の概要

世界の医療機器試験・検査・認証アウトソーシングの市場規模は、2024年に31億8,000万米ドルと推計され、2025年から2030年にかけてCAGR 8.48%で成長し、2030年には51億1,000万米ドルに達すると予測されます。市場成長の主な要因は、厳しい規制シナリオ、技術革新サイクルの加速、診断、治療、ウェアラブルの各カテゴリーにおけるデバイスの複雑性の拡大です。

米国FDA、EU MDR、中国NMPAなど、各地域の規制当局による監視が強化され、コンプライアンス、安全性保証、迅速な市場参入のために、第三者のTIC専門知識に対する需要が高まっています。さらに、特にソフトウェア、コネクティビティ、AIの統合に伴う機器設計の複雑化により、社内の複数のチームに欠けている高度な試験能力が求められており、成長機会となっています。さらに、コスト圧力の高まりと業務効率化の必要性も、特に中小製造業者の間でTICサービスのアウトソーシングを強化しています。医療機器の世界の取引の拡大は、標準化された認証サービスへの需要をさらに押し上げます。

埋め込み型、能動的治療システム、デジタル診断を含む、高リスクで技術的に高度なクラスIIおよびIII機器の商業化が加速しているため、臨床バリデーション、電気安全性、生体適合性、サイバーセキュリティ試験に対する要件が強化されています。このような機器には多領域にわたるTICの専門知識が要求されるため、専門の第三者サービスプロバイダーに対する需要が高まっています。さらに、強制的な市販後調査（PMS）、ビジランス報告、定期的安全性更新報告（PSUR）の要件により、市販後のエビデンス生成とコンプライアンス活動の量と複雑さが増しています。例えば、欧州連合の医療機器規制（MDR）と体外診断薬規制（IVDR）は、特にクラスIIとIIIの機器に対して、より厳しいコンプライアンス評価を導入しています。規制当局はしばしば、機器のライフサイクルにわたる継続的な性能評価を要求するため、OEMは定期的な試験、リスク管理、有害事象分析を適格なTICパートナーに委託するようになっています。

さらに、世界の規制当局は、ノーティファイドボディや認定代理店に対する監視を強化し、承認や更新に必要な技術文書基準を改善しています。例えば、2021年4月、FDAはULを、医療機器の安全性試験に関する適合性評価認定制度（ASCA）に基づくISO/IEC 17025試験所として認定しました。このように、法規制遵守の圧力が高まる中、OEMは、認定された能力、国境を越えた法規制に関する知識、統合された試験ポートフォリオを持つTICベンダーと契約することで、法規制リスクの軽減、タイムラインの短縮、コスト構造の最適化を図っています。その結果、TICアウトソーシング市場は、取引中心のサービスモデルから、規制情報および品質システムの専門知識を組み込んだ長期的でコンプライアンス主導のパートナーシップへと移行しつつあります。

医療機器の製造・サプライチェーンの国際化は、世界の医療機器試験・検査・認証（TIC）アウトソーシング業界の成長を加速させる主要な構造的原動力となっています。相手先商標製品製造業者（OEM）がコスト、関税、規制リスクを軽減するために複数の地域に製造を分散するにつれ、TIC要件はより複雑化し、複数の管轄区域にまたがるようになり、頻度も高まっています。このような地理的分散には、FDA（米国）、MDR（EU）、PMDA（日本）などの地域特有の規制枠組みへの一貫したコンプライアンスを強化するために、ISOやIEC規格と並んで、独立した第三者による検証が必要です。さらに、製造受託機関（CMO）の急増と、設計、組立、部品製造にわたるアウトソーシングの強化は、品質保証の複雑性を高めています。世界・サプライチェーンはトレーサビリティとアカウンタビリティのリスクを拡大するため、エンド・ツー・エンドのTICサービス、特にインプラント、診断、デジタル接続機器などリスクの高いカテゴリーにおける需要が拡大します。

これと並行して、機器サプライチェーンにおけるリアルタイムのデータ交換とソフトウェア統合には、厳格なサイバーセキュリティとソフトウェア検証監査が必要となり、医療機器TICアウトソーシング市場の成長はさらに拡大します。加えて、規制当局が輸入機器に対する監視を強化する中、メーカー各社はコンプライアンス違反を最小限に抑えつつ市場参入を迅速化するため、サードパーティTICプロバイダーへの依存度を高めています。例えば、2023年3月、米国FDAは、2023年統合歳出法（オムニバス）の下で「機器のサイバーセキュリティの確保」に関するセクション524Bを導入し、すべての新しい医療機器の市販前申請にサイバーセキュリティ情報を含めることを義務付けました。これは、連邦食品医薬品化粧品法（FD&C法）内で初の法的拘束力のあるサイバーセキュリティ要件であり、すべてのクラスIIおよびIIIの機器申請に影響を与えます。その結果、TICアウトソーシングは、国際化した医療機器製造エコシステムの中で、取引上のコンプライアンス機能から戦略的なリスク軽減手段へと進化しつつあります。

目次

第1章 分析方法・範囲

第2章 エグゼクティブサマリー

第3章 医療機器試験・検査・認証アウトソーシング市場：変動要因・傾向・範囲

• 市場連関の見通し
  • 親市場の見通し
  • 関連/付随市場の見通し
• 市場力学
  • 市場促進要因の分析
  • 市場抑制要因の分析
• 技術進歩
• 価格モデル分析
• 市場分析ツール
  • ポーターのファイブフォース分析
  • PESTEL分析
  • COVID-19の影響分析
  • 米国関税の影響分析

第4章 医療機器試験・検査・認証アウトソーシング市場：サービス別の推定・動向分析

• セグメントダッシュボード
• 医療機器試験・検査・認証アウトソーシング市場：変動分析、サービス別
• サービス別（2018年～2030年）
• テスト
• テスト
• 認証

第5章 医療機器試験・検査・認証アウトソーシング市場：機器クラス別の推定・動向分析

• セグメントダッシュボード
• 医療機器試験・検査・認証アウトソーシング市場：変動分析、機器クラス別
• 機器クラス別（2018年～2030年）
• クラスI
• クラスII
• クラスIII

第6章 医療機器試験・検査・認証アウトソーシング市場：最終用途別の推定・動向分析

• セグメントダッシュボード
• 医療機器試験・検査・認証アウトソーシング市場：変動分析、最終用途別
• 最終用途別（2018年～2030年）
• 医療機器企業
• 製薬およびバイオテクノロジー企業
• その他

第7章 医療機器試験・検査・認証アウトソーシング市場：地域別の推定・動向分析

• 地域市場ダッシュボード
• 市場シェア分析：地域別（2024年・2030年）
• 地域別（2018年～2030年）
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • 英国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • デンマーク
  • スウェーデン
  • ノルウェー
• アジア太平洋
  • 中国
  • 日本
  • インド
  • 韓国
  • オーストラリア
  • タイ
  • インドネシア
  • マレーシア
  • シンガポール
  • 台湾
• ラテンアメリカ
  • ブラジル
  • アルゼンチン
  • コロンビア
  • チリ
• 中東・アフリカ
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦
  • クウェート
  • イスラエル

第8章 競合情勢

• 企業分類
  • 市場リーダー
  • 新興企業
• 企業市況分析（企業ヒートマップ分析）（2024年）
• 企業プロファイル
  • SGS SA
  • Intertek Group plc
  • Eurofins Scientific SE
  • DEKRA CERTIFICATION BV
  • UL Solutions Inc.
  • TUV SUD
  • ALS Limited
  • Bureau Veritas SA
  • NSF International
  • Element Materials Technology
  • Nelson Labs
  • Pace Analytical Life Sciences
  • ITS Testing Services
  • DNV（Det Norske Veritas）
  • Korea Testing Certification

List of Tables

• Table 1 List of Secondary Sources
• Table 2 List of Abbreviations
• Table 3 Global Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 4 Global Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 5 Global Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 6 Global Medical Device Testing, Inspection and Certification Outsourcing Market, by Region, 2018 - 2030 (USD Million)
• Table 7 North America Medical Device Testing, Inspection and Certification Outsourcing Market, by Country, 2018 - 2030 (USD Million)
• Table 8 North America Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 9 North America Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 10 North America Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 11 U.S. Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 12 U.S. Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 13 U.S. Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 14 Canada Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 15 Canada Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 16 Canada Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 17 Mexico Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 18 Mexico Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 19 Mexico Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 20 Europe Medical Device Testing, Inspection and Certification Outsourcing Market, by Country, 2018 - 2030 (USD Million)
• Table 21 Europe Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 22 Europe Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 23 Europe Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 24 UK Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 25 UK Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 26 UK Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 27 Germany Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 28 Germany Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 29 Germany Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 30 France Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 31 France Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 32 France Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 33 Italy Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 34 Italy Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 35 Italy Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 36 Spain Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 37 Spain Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 38 Spain Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 39 Denmark Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 40 Denmark Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 41 Denmark Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 42 Sweden Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 43 Sweden Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 44 Sweden Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 45 Norway Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 46 Norway Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 47 Norway Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 48 Asia Pacific Medical Device Testing, Inspection and Certification Outsourcing Market, by Country, 2018 - 2030 (USD Million)
• Table 49 Asia Pacific Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 50 Asia Pacific Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 51 Asia Pacific Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 52 Japan Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 53 Japan Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 54 Japan Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 55 China Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 56 China Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 57 China Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 58 India Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 59 India Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 60 India Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 61 Australia Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 62 Australia Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 63 Australia Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 64 South Korea Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 65 South Korea Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 66 South Korea Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 67 Thailand Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 68 Thailand Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 69 Thailand Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 70 Indonesia Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 71 Indonesia Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 72 Indonesia Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 73 Malaysia Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 74 Malaysia Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 75 Malaysia Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 76 Singapore Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 77 Singapore Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 78 Singapore Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 79 Taiwan Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 80 Taiwan Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 81 Taiwan Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 82 Latin America Medical Device Testing, Inspection and Certification Outsourcing Market, by Country, 2018 - 2030 (USD Million)
• Table 83 Latin America Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 84 Latin America Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 85 Latin America Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 86 Brazil Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 87 Brazil Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 88 Brazil Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 89 Argentina Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 90 Argentina Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 91 Argentina Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 92 Colombia Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 93 Colombia Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 94 Colombia Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 95 Chile Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 96 Chile Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 97 Chile Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 98 Middle East & Africa Medical Device Testing, Inspection and Certification Outsourcing Market, by Country, 2018 - 2030 (USD Million)
• Table 99 Middle East & Africa Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 100 Middle East & Africa Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 101 Middle East & Africa Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 102 South Africa Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 103 South Africa Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 104 South Africa Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 105 Saudi Arabia Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 106 Saudi Arabia Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 107 Saudi Arabia Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 108 UAE Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 109 UAE Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 110 UAE Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 111 Kuwait Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 112 Kuwait Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 113 Kuwait Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)
• Table 114 Israel Medical Device Testing, Inspection and Certification Outsourcing Market, by Service, 2018 - 2030 (USD Million)
• Table 115 Israel Medical Device Testing, Inspection and Certification Outsourcing Market, by Device Class, 2018 - 2030 (USD Million)
• Table 116 Israel Medical Device Testing, Inspection and Certification Outsourcing Market, by End Use, 2018 - 2030 (USD Million)

List of Figures

• Fig. 1 Medical Device Testing, Inspection and Certification Outsourcing, Market Segmentation
• Fig. 2 Market research process
• Fig. 3 Information Procurement
• Fig. 4 Primary Research Pattern
• Fig. 5 Market Research Approaches
• Fig. 6 Value Chain-Based Sizing & Forecasting
• Fig. 7 Market Formulation & Validation
• Fig. 8 Market Dynamics
• Fig. 9 Market Driver Relevance Analysis (Current & Future Impact)
• Fig. 10 Market Restraint Relevance Analysis (Current & Future Impact)
• Fig. 11 Porter's Five Forces Analysis
• Fig. 12 PESTEL by SWOT Analysis
• Fig. 13 Regional Marketplace: Key Takeaways
• Fig. 14 Global Testing Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 15 Global Inspection Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 16 Global Certification Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 17 Global Class I Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 18 Global Class II Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 19 Global Class III Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 20 Global Medical Device Companies Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 21 Global Pharmaceutical and Biotech Companies Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 22 Global Others Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 23 Regional Outlook, 2024 & 2030
• Fig. 24 North America Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 25 U.S. Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 26 Canada Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 27 Mexico Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 28 Europe Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 29 UK Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 30 Germany Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 31 France Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 32 Italy Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 33 Spain Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 34 Denmark Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 35 Sweden Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 36 Norway Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 37 Asia Pacific Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 38 Japan Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 39 China Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 40 India Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 41 Australia Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 42 South Korea Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 43 Indonesia Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 44 Malaysia Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 45 Singapore Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 46 Thailand Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 47 Taiwan Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 48 Latin America Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 49 Brazil Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 50 Argentina Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 51 Colombia Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 52 Chile Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 53 MEA Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 54 South Africa Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 55 Saudi Arabia Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 56 UAE Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 57 Kuwait Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• Fig. 58 Israel Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Medical Device Testing, Inspection And Certification Outsourcing Market Summary

The global medical device testing, inspection, and certification outsourcing market size was estimated at USD 3.18 billion in 2024 and is projected to reach USD 5.11 billion by 2030, growing at a CAGR of 8.48% from 2025 to 2030. The market growth is primarily attributable to the stringent regulatory scenario, accelerated innovation cycles, and expanding device complexity across diagnostic, therapeutic, and wearable categories.

Growing scrutiny from several regulatory bodies across regions, such as the U.S. FDA, EU MDR, and China's NMPA, has enhanced demand for third-party TIC expertise for compliance, safety assurance, and faster market access. Moreover, rising complexity in device design, particularly with the integration of software, connectivity, and AI, demands advanced testing capabilities that several in-house teams lack, offering growth opportunities. Furthermore, increasing cost pressures and the need for operational efficiency also enhance outsourcing TIC services, especially among small and mid-sized manufacturers. Growing global trade of medical devices further boosts demand for standardized certification services.

The accelerating commercialization of high-risk, technologically advanced Class II and III devices, including implantables, active therapeutic systems, and digital diagnostics, has strengthened requirements for clinical validation, electrical safety, biocompatibility, and cybersecurity testing. These devices demand multi-domain TIC expertise, driving demand for specialized third-party service providers. Furthermore, mandatory post-market surveillance (PMS), vigilance reporting, and periodic safety update reporting (PSUR) requirements are increasing the volume and complexity of post-market evidence generation and compliance activities. For instance, the European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have introduced more severe compliance assessments, especially for Class II and III devices. Regulatory authorities often require continuous performance evaluation across device lifecycles, leading OEMs to outsource recurring testing, risk management, and adverse event analytics to qualified TIC partners.

Additionally, global regulators are strengthening oversight on notified bodies and authorized representatives, improving the technical documentation standards required for approvals and renewals. For instance, in April 2021, the FDA accredited UL as an ISO/IEC 17025 laboratory under the Accreditation Scheme for Conformity Assessment (ASCA) for medical device safety testing. Thus, rising regulatory compliance pressure prompts OEMs to mitigate regulatory risk, compress timelines, and optimize cost structures by engaging TIC vendors with accredited capabilities, cross-border regulatory knowledge, and integrated testing portfolios. As a result, the TIC outsourcing market is shifting from a transactional service model toward long-term, compliance-driven partnerships with embedded regulatory intelligence and quality systems expertise.

The globalization of medical device manufacturing and supply chains is a key structural driver accelerating growth in the global medical device testing, inspection, and certification (TIC) outsourcing industry. As Original Equipment Manufacturers (OEMs) diversify production across multiple geographies to mitigate cost, tariff, and regulatory risks, TIC requirements become more complex, multi-jurisdictional, and frequent. This geographic distribution requires independent third-party verification to enhance consistent compliance with region-specific regulatory frameworks such as FDA (U.S.), MDR (EU), and PMDA (Japan), alongside ISO and IEC standards. Moreover, the proliferation of contract manufacturing organizations (CMOs) and increased outsourcing intensity across design, assembly, and component production enhance quality assurance complexity. Global supply chains expand traceability and accountability risks, thereby expanding demand for end-to-end TIC services, particularly in high-risk categories such as implantables, diagnostics, and digitally connected devices.

In parallel, real-time data exchange and software integration in device supply chains require rigorous cybersecurity and software validation audits, further expanding the medical device TIC outsourcing market growth. In addition, as regulatory authorities increase scrutiny of imported devices, manufacturers increasingly rely on third-party TIC providers to expedite market entry while minimizing compliance lapses. For instance, in March 2023, the U.S. FDA introduced Section 524B on "Ensuring Cybersecurity of Devices" under the Consolidated Appropriations Act (Omnibus), 2023, mandating that all new medical device premarket submissions include cybersecurity information. This marked the first legally binding cybersecurity requirement within the Federal Food, Drug, and Cosmetic Act (FD&C Act), impacting all Class II and III device submissions. As a result, TIC outsourcing is evolving from a transactional compliance function to a strategic risk mitigation lever within globalized medical device manufacturing ecosystems.

Global Medical Device Testing, Inspection And Certification Outsourcing Market Report Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global medical device testing, inspection and certification outsourcing market report based on service, drug class, end use, and region:

• Service Outlook (Revenue, USD Million, 2018 - 2030)
• Testing
• Inspection
• Certification
• Device Class Outlook (Revenue, USD Million, 2018 - 2030)
• Class I
• Class II
• Class III
• End Use Outlook (Revenue, USD Million, 2018 - 2030)
• Medical Device Companies
• Pharmaceutical and Biotech Companies
• Others
• Regional Outlook (Revenue, USD Million, 2018 - 2030)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • India
  • China
  • Japan
  • South Korea
  • Australia
  • Thailand
  • Indonesia
  • Malaysia
  • Singapore
  • Taiwan
• Latin America
  • Brazil
  • Argentina
  • Colombia
  • Chile
• Middle East and Africa (MEA)
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait
  • Israel

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Market Definitions
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased database
  • 1.4.2. GVR's internal database
  • 1.4.3. Secondary sources
  • 1.4.4. Primary research
• 1.5. Information or Data Analysis
  • 1.5.1. Data analysis models
• 1.6. Market Formulation & Validation
• 1.7. Model Details
  • 1.7.1. Commodity flow analysis (Model 1)
  • 1.7.2. Value chain-based analysis (Model 2)
  • 1.7.3. Multivariate Analysis (Model 3)
• 1.8. List of Secondary Sources
• 1.9. List of Primary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

Chapter 3. Medical Device Testing, Inspection and Certification Outsourcing Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent market outlook
  • 3.1.2. Related/ancillary market outlook
• 3.2. Market Dynamics
  • 3.2.1. Market driver analysis
  • 3.2.2. Market restraint analysis
• 3.3. Technological Advancements
• 3.4. Pricing Model Analysis
• 3.5. Market Analysis Tools
  • 3.5.1. Porter's five forces analysis
  • 3.5.2. PESTEL analysis
  • 3.5.3. COVID-19 Impact Analysis
  • 3.5.4. U.S. Tariff Impact Analysis

Chapter 4. Medical Device Testing, Inspection and Certification Outsourcing Market: Service Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Medical Device Testing, Inspection and Certification Outsourcing Market: Service Movement Analysis
• 4.3. Medical Device Testing, Inspection and Certification Outsourcing Market Estimates & Forecasts, by Service, 2018 - 2030 (USD Million)
• 4.4. Testing
  • 4.4.1. Testing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.5. Testing
  • 4.5.1. Inspection Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.6. Certification
  • 4.6.1. Certification Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 5. Medical Device Testing, Inspection and Certification Outsourcing Market: Device Class Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Medical Device Testing, Inspection and Certification Outsourcing Market: Device Class Movement Analysis
• 5.3. Medical Device Testing, Inspection and Certification Outsourcing: Market Estimates & Forecasts, by Device Class, 2018 - 2030 (USD Million)
• 5.4. Class I
  • 5.4.1. Class I Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.5. Class II
  • 5.5.1. Class II Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.6. Class III
  • 5.6.1. Class III Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 6. Medical Device Testing, Inspection and Certification Outsourcing Market: End Use Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. Medical Device Testing, Inspection and Certification Outsourcing Market: End Use Movement Analysis
• 6.3. Medical Device Testing, Inspection and Certification Outsourcing: Market Estimates & Forecasts, by End Use, 2018 - 2030 (USD Million)
• 6.4. Medical Device Companies
  • 6.4.1. Medical Device Companies Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.5. Pharmaceutical and Biotech Companies
  • 6.5.1. Pharmaceutical and Biotech Companies Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.6. Others
  • 6.6.1. Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 7. Medical Device Testing, Inspection and Certification Outsourcing Market: Regional Estimates & Trend Analysis

• 7.1. Regional Market Dashboard
• 7.2. Regional market share analysis, 2024 & 2030
• 7.3. Global Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, by Region, 2018 - 2030 (USD Million)
• 7.4. North America
  • 7.4.1. North America Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.4.2. U.S.
    • 7.4.2.1. Key Country Dynamics
    • 7.4.2.2. Competitive Scenario
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. U.S. Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.4.3. Canada
    • 7.4.3.1. Key Country Dynamics
    • 7.4.3.2. Competitive Scenario
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. Canada Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.4.4. Mexico
    • 7.4.4.1. Key Country Dynamics
    • 7.4.4.2. Competitive Scenario
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. Mexico Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.5. Europe
  • 7.5.1. Europe Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.2. UK
    • 7.5.2.1. Key Country Dynamics
    • 7.5.2.2. Competitive Scenario
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. UK Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.3. Germany
    • 7.5.3.1. Key Country Dynamics
    • 7.5.3.2. Competitive Scenario
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. Germany Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.4. France
    • 7.5.4.1. Key Country Dynamics
    • 7.5.4.2. Competitive Scenario
    • 7.5.4.3. Regulatory Framework
    • 7.5.4.4. France Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.5. Italy
    • 7.5.5.1. Key Country Dynamics
    • 7.5.5.2. Competitive Scenario
    • 7.5.5.3. Regulatory Framework
    • 7.5.5.4. Italy Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.6. Spain
    • 7.5.6.1. Key Country Dynamics
    • 7.5.6.2. Competitive Scenario
    • 7.5.6.3. Regulatory Framework
    • 7.5.6.4. Spain Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.7. Denmark
    • 7.5.7.1. Key Country Dynamics
    • 7.5.7.2. Competitive Scenario
    • 7.5.7.3. Regulatory Framework
    • 7.5.7.4. Denmark Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.8. Sweden
    • 7.5.8.1. Key Country Dynamics
    • 7.5.8.2. Competitive Scenario
    • 7.5.8.3. Regulatory Framework
    • 7.5.8.4. Sweden Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.5.9. Norway
    • 7.5.9.1. Key Country Dynamics
    • 7.5.9.2. Competitive Scenario
    • 7.5.9.3. Regulatory Framework
    • 7.5.9.4. Norway Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.6. Asia Pacific
  • 7.6.1. Asia Pacific Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.2. China
    • 7.6.2.1. Key Country Dynamics
    • 7.6.2.2. Competitive Scenario
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. China Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.3. Japan
    • 7.6.3.1. Key Country Dynamics
    • 7.6.3.2. Competitive Scenario
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. Japan Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.4. India
    • 7.6.4.1. Key Country Dynamics
    • 7.6.4.2. Competitive Scenario
    • 7.6.4.3. Regulatory Framework
    • 7.6.4.4. India Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.5. South Korea
    • 7.6.5.1. Key Country Dynamics
    • 7.6.5.2. Competitive Scenario
    • 7.6.5.3. Regulatory Framework
    • 7.6.5.4. South Korea Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.6. Australia
    • 7.6.6.1. Key Country Dynamics
    • 7.6.6.2. Competitive Scenario
    • 7.6.6.3. Regulatory Framework
    • 7.6.6.4. Australia Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.7. Thailand
    • 7.6.7.1. Key Country Dynamics
    • 7.6.7.2. Competitive Scenario
    • 7.6.7.3. Regulatory Framework
    • 7.6.7.4. Thailand Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.8. Indonesia
    • 7.6.8.1. Key Country Dynamics
    • 7.6.8.2. Competitive Scenario
    • 7.6.8.3. Regulatory Framework
    • 7.6.8.4. Indonesia Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.9. Malaysia
    • 7.6.9.1. Key Country Dynamics
    • 7.6.9.2. Competitive Scenario
    • 7.6.9.3. Regulatory Framework
    • 7.6.9.4. Malaysia Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.10. Singapore
    • 7.6.10.1. Key Country Dynamics
    • 7.6.10.2. Competitive Scenario
    • 7.6.10.3. Regulatory Framework
    • 7.6.10.4. Singapore Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.6.11. Taiwan
    • 7.6.11.1. Key Country Dynamics
    • 7.6.11.2. Competitive Scenario
    • 7.6.11.3. Regulatory Framework
    • 7.6.11.4. Taiwan Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.7. Latin America
  • 7.7.1. Latin America Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.7.2. Brazil
    • 7.7.2.1. Key Country Dynamics
    • 7.7.2.2. Competitive Scenario
    • 7.7.2.3. Regulatory Framework
    • 7.7.2.4. Brazil Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.7.3. Argentina
    • 7.7.3.1. Key Country Dynamics
    • 7.7.3.2. Competitive Scenario
    • 7.7.3.3. Regulatory Framework
    • 7.7.3.4. Argentina Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.7.4. Colombia
    • 7.7.4.1. Key Country Dynamics
    • 7.7.4.2. Competitive Scenario
    • 7.7.4.3. Regulatory Framework
    • 7.7.4.4. Colombia Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.7.5. Chile
    • 7.7.5.1. Key Country Dynamics
    • 7.7.5.2. Competitive Scenario
    • 7.7.5.3. Regulatory Framework
    • 7.7.5.4. Chile Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.8. Middle East and Africa
  • 7.8.1. Middle East and Africa Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.2. South Africa
    • 7.8.2.1. Key Country Dynamics
    • 7.8.2.2. Competitive Scenario
    • 7.8.2.3. Regulatory Framework
    • 7.8.2.4. South Africa Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.3. Saudi Arabia
    • 7.8.3.1. Key Country Dynamics
    • 7.8.3.2. Competitive Scenario
    • 7.8.3.3. Regulatory Framework
    • 7.8.3.4. Saudi Arabia Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.4. UAE
    • 7.8.4.1. Key Country Dynamics
    • 7.8.4.2. Competitive Scenario
    • 7.8.4.3. Regulatory Framework
    • 7.8.4.4. UAE Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.5. Kuwait
    • 7.8.5.1. Key Country Dynamics
    • 7.8.5.2. Competitive Scenario
    • 7.8.5.3. Regulatory Framework
    • 7.8.5.4. Kuwait Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.8.6. Israel
    • 7.8.6.1. Key Country Dynamics
    • 7.8.6.2. Competitive Scenario
    • 7.8.6.3. Regulatory Framework
    • 7.8.6.4. Israel Medical Device Testing, Inspection and Certification Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Company Categorization
  • 8.1.1. Market Leaders
  • 8.1.2. Emerging Players
• 8.2. Company Market Position Analysis, 2024 (Company Heat Map Analysis)
• 8.3. Company Profiles
  • 8.3.1. SGS SA
    • 8.3.1.1. Participant's Overview
    • 8.3.1.2. Financial Performance
    • 8.3.1.3. Service Benchmarking
    • 8.3.1.4. Strategic Initiatives
  • 8.3.2. Intertek Group plc
    • 8.3.2.1. Participant's Overview
    • 8.3.2.2. Financial Performance
    • 8.3.2.3. Service Benchmarking
    • 8.3.2.4. Strategic Initiatives
  • 8.3.3. Eurofins Scientific SE
    • 8.3.3.1. Participant's Overview
    • 8.3.3.2. Financial Performance
    • 8.3.3.3. Service Benchmarking
    • 8.3.3.4. Strategic Initiatives
  • 8.3.4. DEKRA CERTIFICATION B.V.
    • 8.3.4.1. Participant's Overview
    • 8.3.4.2. Financial Performance
    • 8.3.4.3. Service Benchmarking
    • 8.3.4.4. Strategic Initiatives
  • 8.3.5. UL Solutions Inc.
    • 8.3.5.1. Participant's Overview
    • 8.3.5.2. Financial Performance
    • 8.3.5.3. Service Benchmarking
    • 8.3.5.4. Strategic Initiatives
  • 8.3.6. TUV SUD
    • 8.3.6.1. Participant's Overview
    • 8.3.6.2. Financial Performance
    • 8.3.6.3. Service Benchmarking
    • 8.3.6.4. Strategic Initiatives
  • 8.3.7. ALS Limited
    • 8.3.7.1. Participant's Overview
    • 8.3.7.2. Financial Performance
    • 8.3.7.3. Service Benchmarking
    • 8.3.7.4. Strategic Initiatives
  • 8.3.8. Bureau Veritas SA
    • 8.3.8.1. Participant's Overview
    • 8.3.8.2. Financial Performance
    • 8.3.8.3. Service Benchmarking
    • 8.3.8.4. Strategic Initiatives
  • 8.3.9. NSF International
    • 8.3.9.1. Participant's Overview
    • 8.3.9.2. Financial Performance
    • 8.3.9.3. Service Benchmarking
    • 8.3.9.4. Strategic Initiatives
  • 8.3.10. Element Materials Technology
    • 8.3.10.1. Participant's Overview
    • 8.3.10.2. Financial Performance
    • 8.3.10.3. Service Benchmarking
    • 8.3.10.4. Strategic Initiatives
  • 8.3.11. Nelson Labs
    • 8.3.11.1. Participant's Overview
    • 8.3.11.2. Financial Performance
    • 8.3.11.3. Service Benchmarking
    • 8.3.11.4. Strategic Initiatives
  • 8.3.12. Pace Analytical Life Sciences
    • 8.3.12.1. Participant's Overview
    • 8.3.12.2. Financial Performance
    • 8.3.12.3. Service Benchmarking
    • 8.3.12.4. Strategic Initiatives
  • 8.3.13. ITS Testing Services
    • 8.3.13.1. Participant's Overview
    • 8.3.13.2. Financial Performance
    • 8.3.13.3. Service Benchmarking
    • 8.3.13.4. Strategic Initiatives
  • 8.3.14. DNV (Det Norske Veritas)
    • 8.3.14.1. Participant's Overview
    • 8.3.14.2. Financial Performance
    • 8.3.14.3. Service Benchmarking
    • 8.3.14.4. Strategic Initiatives
  • 8.3.15. Korea Testing Certification
    • 8.3.15.1. Participant's Overview
    • 8.3.15.2. Financial Performance
    • 8.3.15.3. Service Benchmarking
    • 8.3.15.4. Strategic Initiatives