ISO 13485の認証取得は必須か

ISO 13485の認証取得は必須か

筆者はしばしば医療機器のスタートアップ企業などから、ISO 13485の認証取得の支援コンサルテーションを依頼される。
しかしである。ISO 13485の認証取得は必ずしも必須ではない。
日本の場合、QMS省令に適合してQMSを構築・運用していれば良く、米国の場合は21 CFR Part 820 QSRなどに準拠してQMSを構築・運用していれば良い。
また、実は欧州においてもISO 13485の認証取得は必須ではないのである。
なぜならば、欧州のCEマーキング制度は自己宣言であるためである。
ISO 13485を遵守して医療機器の設計・製造を実施している旨を適合宣言書として自己宣言すれば良いのである。

MDR(欧州医療機器規制)における整合規格

2022年1月4日付で新たに9つの規格が欧州整合規格として認定された。医療機器の生物学的評価、滅菌、無菌処理、品質管理システム、製品情報での記号の使用などの規格である。
これで欧州MDRの下で認定された整合規格は現時点で14規格になった。
これにより、EN ISO 13485:2016も、やっとMDRの整合規格となったのである。

整合規格に準拠するメリット

整合規格に準拠するという意味は下記の通りである。

In accordance with Article 8(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council (2), devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, are to be presumed to be in conformity with the requirements of that Regulation covered by those standards or parts thereof.
(欧州議会および理事会(2)の規則(EU)2017/745の第8条(1)に従い、関連する整合規格またはそれらの規格の関連部分に準拠している機器、EU官報に掲載されているものは、それらの規格またはその一部がカバーするその規則の要件に準拠していると推定される。)

つまり、整合規格に準拠すれば、MDRの該当する要件を満たしているとpresume(推定)されるというのが整合規格への準拠のメリットである
本邦においても、ISO 13485の認証を取得していれば、品目申請時の実地調査が軽減されることがあり、ISO 13485の認証を取得するメリットはある。

https://www.youtube.com/watch?v=qMpOt1hWhbU&feature=youtu.be

関連商品

[blogcard url=”https://xn--2lwu4a.jp/qms-md/” title=”QMS(手順書)ひな形 医療機器関連” ]

Related post

Comment

  1. allergy pills for adults allergy pills prescribed by doctors how long do antihistamines take to work

  2. top 10 strongest sleeping pills buy phenergan 25mg sale

  3. deltasone 20mg for sale deltasone 40mg generic

  4. is taking acid blockers bad coversyl 4mg usa

  5. prescription acne medications brand names order retino gel adult acne medication pill

  6. mayo clinic stomach acid zyloprim ca

  7. accutane 40mg generic accutane 10mg drug buy cheap isotretinoin

  8. virtual visit online physician belsomra melatonin 3 mg over the counter

  9. order amoxil 500mg pill amoxil without prescription amoxicillin 250mg canada

  10. buy zithromax 250mg for sale azithromycin 500mg pills how to buy zithromax

  11. gabapentin 600mg usa neurontin cheap

  12. purchase azipro without prescription order azipro for sale order azithromycin 500mg sale

  13. oral furosemide 40mg furosemide 100mg usa

  14. omnacortil 20mg generic buy prednisolone 20mg for sale buy omnacortil no prescription

  15. deltasone cheap order prednisone 40mg pill

  16. order amoxicillin 500mg without prescription buy cheap generic amoxicillin buy amoxil 250mg sale

  17. monodox online buy vibra-tabs oral

  18. ventolin canada purchase albuterol inhalator generic albuterol 4mg us

  19. order augmentin online buy cheap clavulanate

  20. levothroid price synthroid cheap cost synthroid 75mcg

  21. cheap vardenafil 10mg levitra 10mg us

  22. purchase clomiphene generic serophene canada order serophene without prescription

  23. zanaflex ca zanaflex pills tizanidine 2mg canada

  24. order rybelsus sale semaglutide cost semaglutide 14 mg sale

  25. generic deltasone 10mg prednisone buy online deltasone 40mg us

  26. where to buy semaglutide without a prescription buy generic semaglutide order rybelsus 14 mg for sale

  27. order accutane absorica online order order accutane 20mg for sale

  28. order amoxil 1000mg pill amoxil over the counter buy amoxil 250mg generic

  29. buy albuterol generic albuterol inhalator price albuterol without prescription

  30. azithromycin 250mg pill zithromax where to buy azithromycin 500mg ca

  31. order augmentin 625mg without prescription augmentin sale clavulanate where to buy

  32. buy omnacortil 40mg online cost omnacortil 5mg omnacortil ca

  33. how to get synthroid without a prescription synthroid 150mcg without prescription buy generic levothroid

  34. neurontin online order neurontin pill order generic gabapentin

  35. clomiphene without prescription clomiphene pills purchase serophene generic

  36. furosemide brand purchase furosemide pills buy furosemide cheap

  37. viagra 100mg england overnight delivery for viagra viagra drug

  38. order doxycycline 100mg buy monodox pill order acticlate for sale

  39. oral rybelsus semaglutide 14 mg cost semaglutide ca

  40. online roulette game real money free casino slots blackjack card game

  41. levitra where to buy levitra sale levitra 10mg generic

  42. pregabalin 75mg ca lyrica canada lyrica us

  43. order hydroxychloroquine online order hydroxychloroquine 200mg for sale hydroxychloroquine medication

  44. buy triamcinolone 10mg generic aristocort 10mg pills order triamcinolone 4mg online

  45. buy generic clarinex over the counter how to buy clarinex clarinex 5mg over the counter

  46. cialis 40mg oral order cialis 40mg pills cialis for women

  47. where can i buy cenforce cenforce 50mg tablet cenforce 50mg pills

  48. buy cheap generic claritin buy generic claritin order claritin 10mg generic

  49. buy generic aralen 250mg buy aralen 250mg generic buy cheap generic aralen

  50. order priligy generic buy dapoxetine generic buy misoprostol pills

  51. buy orlistat tablets oral orlistat 60mg buy diltiazem for sale

  52. purchase glucophage for sale metformin 1000mg sale glycomet tablet

  53. acyclovir 800mg oral allopurinol without prescription zyloprim 100mg canada

  54. norvasc over the counter amlodipine pill buy amlodipine 5mg without prescription

  55. brand crestor 10mg zetia pills ezetimibe 10mg tablet

  56. lisinopril buy online buy lisinopril paypal lisinopril 2.5mg uk

  57. domperidone online order sumycin 500mg pill tetracycline ca

  58. order prilosec 20mg online cheap buy generic prilosec over the counter order omeprazole 10mg online

  59. cyclobenzaprine 15mg cost buy flexeril pill ozobax where to buy

  60. purchase lopressor without prescription buy lopressor sale oral metoprolol 100mg

  61. purchase toradol for sale buy toradol pills for sale buy colcrys online

  62. purchase tenormin without prescription atenolol 100mg us order atenolol 50mg generic

  63. order medrol for sale methylprednisolone 4mg without prescription methylprednisolone 4mg tablets

  64. inderal cost buy plavix generic how to buy clopidogrel

  65. cheap essay help help writing a research paper order research paper

  66. methotrexate order online order generic methotrexate buy coumadin 5mg for sale

  67. purchase maxolon online cheap order reglan 20mg pills buy cozaar without prescription

  68. meloxicam 15mg pills how to buy celebrex celecoxib for sale online

  69. where to buy nexium without a prescription order nexium 20mg pills topamax tablet

  70. order flomax 0.2mg online cheap celecoxib medication celecoxib sale

  71. buy imitrex without prescription imitrex 50mg brand levofloxacin 500mg for sale

  72. buy ondansetron 4mg online order spironolactone 25mg aldactone tablet

  73. buy generic dutasteride for sale buy generic dutasteride for sale buy zantac without prescription

  74. buy zocor 10mg pill order simvastatin 20mg generic order valacyclovir 1000mg online

  75. order ampicillin pill where to buy ampicillin without a prescription buy generic amoxicillin online

  76. finasteride over the counter buy diflucan pill fluconazole 100mg generic

  77. order cipro 500mg online – amoxiclav cost buy augmentin without prescription

  78. ciprofloxacin us – how to buy clavulanate purchase augmentin generic

  79. flagyl pills – order amoxicillin online cheap purchase zithromax for sale

  80. buy cheap ciprofloxacin – buy generic doxycycline over the counter buy erythromycin 250mg pill

  81. valacyclovir 1000mg over the counter – order nemasole online cheap order acyclovir 800mg generic

  82. ivermectin 3 mg oral – buy co-amoxiclav no prescription sumycin 500mg cheap

  83. buy generic metronidazole – buy generic amoxil over the counter buy azithromycin generic

  84. buy ampicillin without prescription doxycycline online order amoxicillin pill

  85. order generic lasix 40mg – capoten 120mg cheap cost captopril 25 mg

  86. glycomet 1000mg over the counter – combivir sale lincomycin 500 mg uk

  87. retrovir 300mg oral – lamivudine 100mg oral order allopurinol pills

  88. clozaril pill – purchase glimepiride pill buy generic pepcid 40mg

  89. order seroquel generic – brand luvox 50mg buy eskalith tablets

  90. anafranil tablet – order celexa generic order doxepin online

  91. purchase atarax for sale – order fluoxetine pills amitriptyline price

  92. augmentin online buy – how to buy ethambutol purchase baycip online

  93. buy generic amoxil online – order cefuroxime 250mg generic purchase ciprofloxacin generic

  94. cleocin 300mg drug – buy cleocin 300mg generic chloromycetin drug

  95. zithromax 500mg sale – ciplox 500 mg ca cheap ciplox 500mg

  96. ivermectin 6 mg stromectol – doxycycline for sale online cefaclor 250mg uk

  97. ventolin inhaler – seroflo us purchase theo-24 Cr pills

  98. buy depo-medrol generic – purchase zyrtec for sale buy astelin 10 ml without prescription

  99. purchase desloratadine sale – buy desloratadine paypal buy albuterol 2mg for sale

  100. micronase order online – generic glyburide cheap dapagliflozin

  101. glycomet medication – purchase acarbose pills order acarbose 50mg

TOP