医療機器プログラムに該当するかどうかの判断

医療機器プログラムに関するパブコメ募集

「プログラムの医療機器該当性に関するガイドライン」に関するパブリックコメントの募集がされている。
期間：令和3年2月3日～3月4日
医療機器の機能を有するプログラムは平成25年の薬事法（現在の薬機法）改正に伴い、医療機器として規制を受けることとなった。本ガイドライン（案）はどのようなプログラムが医療機器として規制を受けるのかについて示したものである。

医療機器プログラムとは？
原則として、以下を満たすものが医療機器として規制を受けるプログラムに該当する。

【性質】
疾病の診断、治療等に寄与するなど、医療機器としての目的性を有しており、かつ、意図したとおりに機能しない場合に患者（又は使用者）の生命及び健康に影響を与えるおそれがあるプログラム

【形態】
1. インストール等することによってデスクトップパソコン等の汎用コンピュータ又はスマートフォン等の携帯情報端末（以下「汎用コンピュータ等」という。）に医療機器としての機能を与えるもの
2. 有体物である医療機器と組み合わせて使用するもの

医療機器に該当するかどうかの判断
以下に該当するプログラムは医療機器に当たらない。
１．患者説明を目的とするプログラム
２．院内業務支援、メンテナンスを目的とするプログラム
３．使用者（患者や健常者）が自らの医療・健康情報を閲覧等することを目的とするプログラム
・個人の健康記録を保存、管理、表示するプログラム
・スポーツや健康維持を目的とするプログラム
４．生命及び健康に影響を与えるリスクが低いと考えられるプログラム（クラスⅠ医療機器に該当するプログラム）

具体的な判断に関しては、本ガイドライン（案）の別添資料およびフローチャートをご確認されたい。

Related post

Comment

  1. allergy pills non drowsy piriton allergy tablets canada allergy med comparison chart

  2. most potent sleeping pills order melatonin 3 mg generic

  3. buy deltasone 5mg without prescription prednisone 10mg over the counter

  4. prescribed medication for stomach pain buy glimepiride generic

  5. prescription acne medication pills order generic retino-a benzoyl peroxide prescription strength lists

  6. acidity tablet name list buy rulide 150mg online

  7. isotretinoin pills order accutane 40mg for sale buy generic accutane

  8. online pharmacies sleeping pills order meloset 3mg without prescription

  9. order amoxicillin 500mg generic buy cheap generic amoxil buy amoxil 1000mg online

  10. azithromycin 250mg pills buy zithromax without a prescription order zithromax online cheap

  11. brand neurontin 100mg gabapentin pills

  12. azithromycin 250mg pill order azipro 500mg azipro drug

  13. buy generic furosemide over the counter lasix 40mg ca

  14. generic prednisolone 10mg omnacortil 40mg pill buy prednisolone 5mg online cheap

  15. prednisone 10mg us purchase prednisone online

  16. buy amoxicillin tablets cheap generic amoxicillin amoxil 250mg generic

  17. doxycycline 100mg ca buy doxycycline generic

  18. albuterol online buy order ventolin 2mg online albuterol sale

  19. buy clavulanate generic augmentin online buy

  20. buy generic synthroid buy levothroid generic purchase levothyroxine

  21. vardenafil 20mg without prescription buy levitra generic

  22. buy clomiphene 50mg clomid online order clomiphene 100mg tablet

  23. zanaflex over the counter buy tizanidine online order tizanidine sale

  24. how to get semaglutide without a prescription buy generic semaglutide online buy semaglutide 14 mg online cheap

  25. order deltasone 10mg order deltasone 5mg pill deltasone over the counter

  26. semaglutide drug semaglutide order online buy rybelsus 14 mg generic

  27. buy isotretinoin 20mg for sale absorica pills isotretinoin usa

  28. amoxicillin 500mg cheap cheap amoxil sale amoxicillin 250mg canada

  29. strongest over the counter antihistamine buy cheap generic albuterol order ventolin inhalator without prescription

  30. buy zithromax paypal order azithromycin 250mg online cheap buy generic zithromax for sale

  31. order augmentin 1000mg sale order amoxiclav sale augmentin 375mg cheap

  32. order omnacortil online prednisolone for sale omnacortil 5mg cost

  33. order generic levothyroxine synthroid 150mcg price buy levothroid pill

  34. purchase gabapentin for sale order neurontin 800mg online buy gabapentin pill

  35. order clomid 50mg sale purchase serophene sale purchase clomiphene online cheap

  36. lasix pills order furosemide online cheap buy generic lasix

  37. viagra 50mg brand order sildenafil 100mg viagra pill

  38. brand vibra-tabs order vibra-tabs generic doxycycline 200mg cheap

  39. order rybelsus pills rybelsus medication order semaglutide 14mg without prescription

  40. play poker online for money vegas casino online online gambling money sports gambling

  41. vardenafil over the counter order levitra 20mg online cheap levitra drug

  42. order pregabalin 75mg without prescription buy pregabalin 150mg pill brand lyrica

  43. hydroxychloroquine 400mg over the counter brand plaquenil 400mg order generic hydroxychloroquine 400mg

  44. order aristocort 4mg pill order triamcinolone 10mg online cheap buy cheap aristocort

  45. cialis mail order buying cialis cheap tadalafil 20mg without prescription

  46. clarinex generic order clarinex 5mg online cost desloratadine 5mg

  47. order cenforce 50mg pills order cenforce pill cenforce uk

  48. loratadine 10mg cheap order loratadine loratadine 10mg uk

  49. buy chloroquine 250mg generic how to buy aralen buy chloroquine 250mg

  50. order glycomet 500mg without prescription buy glucophage 1000mg brand metformin

  51. order xenical 60mg orlistat 60mg canada buy diltiazem generic

  52. order zovirax 800mg pills order generic zyloprim zyloprim 300mg cost

  53. buy norvasc 5mg generic generic norvasc 10mg norvasc drug

  54. rosuvastatin 10mg cheap purchase ezetimibe online buy zetia cheap

  55. order lisinopril 5mg online cheap prinivil online order zestril generic

  56. order motilium for sale buy motilium cheap tetracycline 250mg brand

  57. buy generic prilosec order omeprazole pills prilosec 10mg canada

  58. buy cyclobenzaprine 15mg pills purchase cyclobenzaprine online buy lioresal without prescription

  59. order metoprolol without prescription buy metoprolol generic order lopressor 50mg generic

  60. ketorolac pill colcrys 0.5mg usa brand colcrys

  61. buy tenormin 50mg sale atenolol 50mg cost atenolol 100mg usa

  62. medrol 8 mg oral medrol generic name methylprednisolone 4 mg without a doctor prescription

  63. inderal 20mg ca purchase clopidogrel pills clopidogrel tablet

  64. help writing essays buy a essay online essays for sale online

  65. purchase methotrexate order methotrexate pill order warfarin 5mg

  66. order reglan 10mg generic hyzaar order online buy losartan generic

  67. meloxicam 15mg ca celecoxib pills buy celecoxib for sale

  68. buy nexium without a prescription esomeprazole 20mg cheap order generic topiramate

  69. buy tamsulosin 0.4mg order tamsulosin 0.2mg pills celebrex 200mg generic

  70. sumatriptan 25mg over the counter order imitrex generic buy levofloxacin pill

  71. buy zofran generic buy ondansetron 4mg without prescription spironolactone 100mg generic

  72. order avodart generic zantac 150mg sale order zantac 150mg online

  73. oral simvastatin 10mg simvastatin 10mg us order valacyclovir 1000mg pills

  74. oral ampicillin how to get acillin without a prescription cheap generic amoxicillin

  75. propecia online buy order proscar online cost diflucan 200mg

  76. brand baycip – order cipro 500mg without prescription amoxiclav canada

  77. order cipro 1000mg sale – order baycip online cheap augmentin 375mg ca

  78. cheap ciplox 500mg – doxycycline where to buy erythromycin for sale online

  79. buy metronidazole 200mg sale – oxytetracycline 250 mg for sale oral zithromax 500mg

  80. stromectol medication – cefuroxime 500mg over the counter buy sumycin tablets

  81. buy valtrex no prescription – starlix canada order zovirax pills

  82. acillin oral order doxycycline online buy amoxil cheap

  83. flagyl price – azithromycin 250mg generic zithromax 250mg brand

  84. furosemide 40mg uk – prograf 5mg usa capoten cheap

  85. purchase glycomet – order duricef 250mg online cheap lincomycin pills

  86. purchase zidovudine generic – roxithromycin online buy allopurinol where to buy

  87. buy clozapine for sale – frumil 5 mg brand buy famotidine 40mg generic

  88. purchase quetiapine generic – buy quetiapine 100mg generic eskalith where to buy

  89. buy anafranil sale – buy amoxapine 50mg online doxepin 75mg brand

  90. buy atarax 10mg sale – lexapro pills buy endep 10mg without prescription

  91. order augmentin 375mg for sale – order augmentin 625mg generic cheap ciprofloxacin 1000mg

  92. buy generic amoxicillin for sale – buy duricef 500mg cipro 1000mg drug

  93. purchase azithromycin without prescription – purchase ciprofloxacin for sale buy ciplox 500mg without prescription

  94. cleocin 150mg generic – suprax 200mg drug purchase chloramphenicol online cheap

  95. ivermectin for sale – order cefaclor without prescription buy cefaclor 250mg online cheap

  96. brand albuterol inhalator – order phenergan online cheap buy theo-24 Cr 400 mg online

  97. medrol 8mg tablet – purchase loratadine buy azelastine nasal spray

  98. clarinex brand – buy clarinex 5mg without prescription brand albuterol inhalator

  99. glyburide price – order glyburide 5mg without prescription dapagliflozin 10 mg uk

  100. buy generic glucophage online – order acarbose 25mg generic buy precose online

  101. pill prandin 2mg – order jardiance 25mg generic order empagliflozin 10mg

  102. generic semaglutide 14mg – desmopressin drug desmopressin ca

  103. buy lamisil medication – order griseofulvin 250mg online cheap grifulvin v over the counter

  104. buy nizoral – butenafine ca buy sporanox generic

  105. famvir canada – generic valcivir 500mg valcivir cost

  106. lanoxin 250 mg canada – order generic calan 240mg buy furosemide pills for sale

  107. order metoprolol online – telmisartan 20mg cheap nifedipine 10mg canada

  108. order hydrochlorothiazide online – buy zestril for sale order zebeta 10mg online

  109. cost nitroglycerin – nitroglycerin for sale online valsartan 80mg for sale

  110. simvastatin very – fenofibrate observe lipitor occasion

  111. crestor susan – caduet pills worm caduet area

  112. buy viagra professional correct – eriacta apart levitra oral jelly online susan

  113. dapoxetine think – sildigra kingdom cialis with dapoxetine severe

  114. cenforce online itself – brand viagra online bitter brand viagra online depend

  115. brand cialis disgust – zhewitra grief penisole already

  116. brand cialis churchyard – alprostadil sweep penisole fantastic

  117. cialis soft tabs crowd – cialis oral jelly online skull viagra oral jelly online limit

  118. cialis soft tabs online splash – cialis oral jelly issue viagra oral jelly guilty

  119. priligy ourself – cialis with dapoxetine establish cialis with dapoxetine focus

  120. cenforce online suffer – cenforce path brand viagra candle

  121. asthma medication experience – asthma treatment boy asthma medication serious

  122. acne medication enter – acne treatment amid acne medication misty

  123. prostatitis pills generous – prostatitis pills september prostatitis medications call

  124. uti antibiotics capture – uti medication true uti treatment face

  125. claritin hundred – loratadine medication hop claritin pills cur

  126. valacyclovir online scale – valacyclovir fall valtrex remark

  127. dapoxetine consider – dapoxetine anxious priligy peril

  128. loratadine medication background – loratadine murder claritin pills print

  129. ascorbic acid edward – ascorbic acid excitement ascorbic acid mansion

  130. promethazine brush – promethazine top promethazine inquire

  131. clarithromycin pills rusty – ranitidine extra cytotec pills acknowledge

  132. florinef pills upon – fludrocortisone pills rough prevacid pills pack

  133. buy rabeprazole 10mg generic – order metoclopramide for sale buy motilium online cheap

  134. bisacodyl us – buy dulcolax pills buy liv52 tablets

  135. zovirax cheap – pill duphaston 10 mg cost dydrogesterone 10 mg

  136. order bactrim 960mg generic – tobra generic buy tobrex generic

  137. griseofulvin 250 mg without prescription – buy generic fulvicin 250mg lopid tablet

  138. forxiga pills – order dapagliflozin acarbose buy online

  139. order dimenhydrinate – prasugrel 10mg us actonel 35mg drug

  140. vasotec 5mg sale – buy enalapril medication buy generic xalatan online

  141. order monograph 600mg online – purchase etodolac online purchase pletal sale

  142. buy piroxicam for sale – order generic feldene 20mg order generic exelon

  143. order piracetam 800mg without prescription – buy sustiva generic order sinemet 10mg for sale

  144. order hydroxyurea without prescription – antabuse 500mg tablet oral methocarbamol

  145. depakote online order – buy aggrenox medication topiramate 200mg price

  146. norpace tablet – pregabalin oral chlorpromazine 100mg for sale

  147. cheap spironolactone – carbamazepine uk revia 50mg pills

  148. buy cytoxan sale – order dramamine 50mg sale vastarel tablet

  149. flexeril order online – generic prasugrel 10 mg brand enalapril 5mg

  150. buy ondansetron 8mg without prescription – oral oxytrol buy cheap generic ropinirole

  151. ascorbic acid 500 mg us – bromhexine sale order compro sale

  152. durex gel buy online – durex gel buy online latanoprost ca

  153. minoxidil medication – order minoxidil order finpecia generic

  154. arava 20mg canada – risedronate pill cartidin medication

  155. purchase verapamil generic – calan brand buy tenoretic no prescription

  156. order atenolol 50mg pill – order carvedilol 6.25mg sale carvedilol 25mg cost

  157. buy atorlip pills – atorlip price buy generic bystolic for sale

  158. cheap gasex for sale – buy generic gasex online purchase diabecon sale

  159. cheap lasuna without prescription – buy himcolin for sale cheap generic himcolin

  160. buy generic noroxin over the counter – order flutamide generic order confido generic

  161. speman canada – cheap fincar pills buy finasteride sale

  162. buy finasteride tablets – order uroxatral 10mg for sale uroxatral ca

  163. buy terazosin for sale – order hytrin 1mg order priligy pill

  164. how to get oxcarbazepine without a prescription – pirfenex order synthroid pills

  165. buy cyclosporine generic – methotrexate 10mg usa order generic colcrys 0.5mg

  166. buy generic duphalac online – mentat cheap betahistine sale

  167. buy deflazacort tablets – buy calcort pill brimonidine order online

  168. besifloxacin oral – purchase carbocysteine pills purchase sildamax

  169. order gabapentin 800mg pill – buy nurofen without prescription generic azulfidine

  170. benemid 500 mg for sale – monograph uk carbamazepine 400mg brand

  171. celebrex 100mg cheap – purchase urispas sale indomethacin 75mg sale

  172. order generic colospa 135mg – mebeverine over the counter pletal 100 mg oral

  173. generic voltaren 50mg – aspirin 75 mg cost aspirin medication

  174. how to buy rumalaya – how to buy elavil endep 50mg sale

  175. pyridostigmine over the counter – order sumatriptan 25mg sale buy azathioprine 50mg online

  176. purchase voveran generic – order isosorbide online buy nimodipine

  177. cheap mobic 7.5mg – buy generic maxalt 10mg buy toradol tablets

  178. buy generic cyproheptadine – periactin 4mg cheap tizanidine buy online

  179. trihexyphenidyl generic – purchase voltaren gel diclofenac gel where to purchase

  180. buy zyban generic – order bupropion 150 mg online buy cheap generic shuddha guggulu

  181. buy capecitabine 500mg pills – ponstel without prescription order danazol 100 mg pills

  182. prometrium 100mg without prescription – order ponstel sale buy clomiphene

  183. fosamax price – fosamax canada provera pills

  184. aygestin tablet – buy lumigan online yasmin pills

  185. dostinex pills – cabgolin online cheap alesse generic

  186. estrace 2mg pill – cost anastrozole 1mg arimidex 1mg for sale

TOP