製造販売業許可はいつまでに取得が必要か

製造販売業許可はいつまでに取得しなければならないか

日本の法律では、医療機器企業として自社ブランドの製品を上市するためには、製造販売業業許可が必要である。
医療機器の場合、製造販売する製品のリスクにより、業許可の種類が異なる。

  • 第一種製造販売業者 一般医療機器(クラスI)
  • 第二種製造販売業者 管理医療機器(クラスII)
  • 第三種製造販売業者 高度管理医療機器(クラスIII、IV)

業許可は、本社所在地(総括の常駐する建屋)の県庁の薬務課に申請を 出し、適合性調査に合格して、得ることが出来る。

製造販売業者の業務は下記の通りである。

  • 医療機器の製造販売承認/認証の取得または届け出の実施
  • 製造販売後安全管理の実施
  • 製造販売する医療機器のサプライチェーン全体を管理するQMSの運用

気を付けなければならないのは、製造販売業者は、「製造」も「販売」も出来ないということである。
「製造」する場合は、製造業登録が必要であり、販売する場合はクラスによって許可または届け出が必要である。

また製造販売業者は、下記の法的責任者である5役を揃えなければならない。

・管理監督者
・管理責任者
・医療機器総括製造販売責任者
・国内品質業務運営責任者
・安全管理責任者
業の種別によっては、兼務要件が異なるので注意が必要だ。

ところで、スタートアップ企業でしばしば問われることがある。製造販売業許可はいつまでに取得しなければならないかということである。
解答は、遅くとも品目の承認/認証までである。ただし、業許可申請が提出されていなければ、品目申請が行えないので、注意が必要である。
また先の本メルマガで記載した通り、ISO 13485の認証取得は不要である。

一方で、米国や欧州などは業許可制度がない。したがって、誰でもが医療機器を設計開発下ならば、品目申請が出来るのである。

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. best allergy pill for itching alternative allergy treatment options alternative allergy treatment options

  2. sleeping tablets without a prescription oral provigil 200mg

  3. prednisone 20mg pill order generic prednisone 20mg

  4. can taking pills cause heartburn duricef 250mg canada

  5. dermatologist prescribed acne cream buy retino gel for sale best acne treatment teenage guys

  6. buy isotretinoin generic cheap accutane 10mg buy accutane generic

  7. sleeping tablets without a prescription buy provigil 100mg pill

  8. amoxicillin 250mg tablet amoxicillin where to buy brand amoxil 1000mg

  9. cost azithromycin order azithromycin 250mg online buy azithromycin sale

  10. buy gabapentin 100mg online cheap cheap gabapentin online

  11. order azithromycin 500mg sale azipro 250mg over the counter azipro online buy

  12. buy lasix 40mg online cheap lasix generic

  13. cheap omnacortil sale order generic prednisolone 10mg prednisolone generic

  14. buy prednisone sale deltasone 5mg generic

  15. buy generic amoxicillin for sale amoxicillin price cheap amoxicillin 250mg

  16. vibra-tabs over the counter buy vibra-tabs online

  17. albuterol inhalator cost albuterol over the counter cheap albuterol 2mg

  18. cheap amoxiclav buy augmentin 625mg for sale

  19. purchase levothyroxine for sale buy synthroid 100mcg pills buy synthroid 75mcg for sale

  20. order generic vardenafil 10mg order generic levitra

  21. serophene us cheap clomid clomiphene tablet

  22. rybelsus 14 mg for sale buy semaglutide without prescription buy semaglutide 14 mg online

  23. order tizanidine 2mg generic buy tizanidine online zanaflex price

  24. prednisone 40mg generic prednisone uk order deltasone 5mg for sale

  25. generic rybelsus 14mg buy rybelsus 14mg for sale purchase rybelsus pills

  26. buy absorica for sale buy isotretinoin cheap accutane 10mg uk

  27. purchase albuterol albuterol inhalator usa brand ventolin inhalator

  28. amoxil 1000mg ca amoxicillin 1000mg over the counter amoxil 250mg pill

  29. augmentin 1000mg oral how to buy clavulanate how to get augmentin without a prescription

  30. buy azithromycin online buy azithromycin 500mg buy zithromax 250mg

  31. cheap levoxyl pill buy synthroid paypal levoxyl uk

  32. omnacortil where to buy generic prednisolone 20mg buy generic omnacortil 10mg

  33. clomid 100mg usa order clomiphene 100mg without prescription buy serophene without prescription

  34. buy generic neurontin for sale buy gabapentin 600mg generic buy gabapentin online cheap

  35. buy furosemide tablets furosemide 100mg over the counter order lasix 40mg for sale

  36. viagra 50mg viagra pills 25mg order viagra 100mg sale

  37. monodox price acticlate brand order acticlate online cheap

  38. semaglutide price buy semaglutide 14 mg sale order semaglutide 14mg for sale

  39. free blackjack games online poker sites free poker online

  40. buy generic vardenafil for sale levitra 20mg pills order generic vardenafil

  41. buy lyrica 75mg sale order pregabalin 75mg sale order pregabalin 150mg

  42. cheap hydroxychloroquine cheap hydroxychloroquine 400mg plaquenil brand

  43. buy triamcinolone online triamcinolone 4mg price triamcinolone 10mg generic

  44. tadalafil oral buying cialis cheap cialis 40mg uk

  45. clarinex buy online buy desloratadine 5mg generic purchase desloratadine

  46. cenforce tablet cenforce 100mg without prescription purchase cenforce without prescription

  47. claritin 10mg pills buy claritin 10mg online cheap buy generic claritin over the counter

  48. aralen tablet chloroquine online aralen sale

  49. dapoxetine 90mg cheap misoprostol for sale order misoprostol

  50. order glucophage 1000mg for sale glucophage 500mg canada glucophage 1000mg for sale

  51. orlistat 60mg without prescription buy diltiazem 180mg pill order diltiazem sale

  52. order amlodipine 10mg pills cheap amlodipine 5mg buy amlodipine sale

  53. zovirax 800mg sale buy zovirax 400mg generic buy allopurinol 100mg

  54. purchase prinivil without prescription zestril 10mg brand lisinopril uk

  55. buy crestor 10mg online purchase crestor generic zetia medication

  56. prilosec 20mg uk prilosec 20mg us buy prilosec online cheap

  57. domperidone 10mg without prescription order domperidone for sale buy sumycin 250mg generic

  58. cheap lopressor buy generic metoprolol online order metoprolol generic

  59. buy cyclobenzaprine 15mg sale buy flexeril online order ozobax pills

  60. oral ketorolac how to get ketorolac without a prescription buy colchicine pills for sale

  61. buy atenolol 50mg tenormin online buy tenormin generic

  62. buy medrol pill buy depo-medrol us buy methylprednisolone 4 mg online

  63. order inderal 10mg how to buy propranolol purchase plavix pills

  64. academic writing uk professional research paper writers write thesis

  65. methotrexate 2.5mg usa order warfarin generic coumadin cost

  66. purchase meloxicam generic buy celebrex without a prescription order celecoxib 200mg

  67. purchase reglan for sale losartan 25mg without prescription hyzaar price

  68. tamsulosin sale tamsulosin for sale celecoxib 100mg generic

  69. order esomeprazole 40mg generic esomeprazole drug buy topamax 200mg generic

  70. ondansetron medication buy generic zofran over the counter where can i buy spironolactone

  71. purchase sumatriptan generic order levaquin 250mg pills order levaquin 250mg pill

  72. zocor for sale order zocor 20mg sale order valtrex 1000mg pill

  73. purchase avodart for sale buy cheap generic ranitidine buy zantac online cheap

  74. ampicillin ca buy amoxil for sale how to get amoxicillin without a prescription

  75. propecia 5mg pill order forcan generic generic diflucan

  76. cipro oral – cheap augmentin order augmentin 375mg pills

  77. purchase cipro without prescription – buy cipro 500mg generic clavulanate usa

  78. buy flagyl online – order cleocin 300mg sale azithromycin 250mg us

  79. oral ciprofloxacin – doxycycline pill buy erythromycin pill

  80. valacyclovir 1000mg cheap – order nemasole buy acyclovir cheap

  81. stromectol oral – sumycin medication tetracycline generic

  82. order metronidazole – azithromycin 250mg us zithromax 500mg oral

  83. acillin without prescription buy generic doxycycline online order amoxicillin without prescription

  84. buy lasix 40mg – where to buy warfarin without a prescription capoten cheap

  85. buy cheap glucophage – glucophage online order purchase lincomycin generic

  86. order zidovudine 300mg pills – purchase glycomet for sale zyloprim pill

  87. order clozaril 100mg – famotidine without prescription pepcid brand

  88. seroquel sale – buy cheap generic sertraline cheap eskalith tablets

  89. clomipramine 50mg tablet – anafranil 50mg drug buy generic sinequan 25mg

  90. atarax online order – order sarafem 40mg pills endep 25mg drug

  91. buy generic amoxicillin – how to get erythromycin without a prescription cheap ciprofloxacin

  92. buy clavulanate pills – purchase ampicillin cipro canada

  93. buy cleocin 300mg without prescription – where can i buy cefixime buy generic chloromycetin over the counter

  94. zithromax 500mg pill – purchase ofloxacin without prescription cheap ciplox 500mg

  95. ivermectin oral – ivermectin 12mg pills purchase cefaclor sale

  96. generic albuterol 4mg – buy promethazine 25mg buy theophylline medication

  97. buy clarinex 5mg pill – buy desloratadine generic order albuterol generic

  98. methylprednisolone online – methylprednisolone drug astelin 10ml nasal spray

  99. buy micronase generic – purchase glipizide online buy dapagliflozin pills for sale

  100. order generic repaglinide – jardiance 25mg sale order jardiance generic

  101. order generic glycomet 1000mg – buy losartan generic where can i buy acarbose

  102. purchase lamisil – fluconazole price buy cheap generic griseofulvin

  103. where can i buy semaglutide – order semaglutide online DDAVP cost

  104. brand nizoral – buy ketoconazole medication sporanox 100mg uk

  105. order famvir 500mg sale – famciclovir 500mg for sale brand valcivir

  106. digoxin 250mg canada – buy dipyridamole without a prescription purchase lasix pills

  107. microzide 25 mg ca – order norvasc 10mg sale cost zebeta

  108. buy metoprolol 50mg pills – order lopressor without prescription adalat us

  109. order nitroglycerin pills – buy generic combipres online valsartan online

  110. rosuvastatin pills reference – ezetimibe online fashion caduet buy dispose

  111. buy zocor 20mg pills – atorvastatin everyone lipitor better

  112. viagra professional bile – super kamagra ill levitra oral jelly artist

  113. priligy amid – suhagra among cialis with dapoxetine smooth

  114. cenforce online preserve – kamagra online throb brand viagra online thorough

  115. brand cialis retire – brand levitra castle penisole nanny

  116. cialis soft tabs pills waist – cialis oral jelly together viagra oral jelly online sea

  117. brand cialis date – brand levitra uneasy penisole beauty

  118. cialis soft tabs pills ward – tadarise pills occasion viagra oral jelly online exact

  119. cenforce online attack – levitra professional online tool brand viagra pills pool

  120. acne medication night – acne medication column acne treatment madness

  121. asthma treatment british – asthma medication cell asthma treatment sofa

  122. uti antibiotics grasp – uti antibiotics worst treatment for uti wine

  123. prostatitis pills trick – prostatitis pills nature prostatitis pills council

  124. valacyclovir attention – valacyclovir pills vanish valacyclovir online suit

  125. claritin pills classroom – claritin pills apply claritin pills joy

  126. dapoxetine mistress – priligy distract priligy mistress

  127. claritin pills circumstance – loratadine praise loratadine medication ernest

  128. promethazine manner – promethazine weep promethazine friend

  129. ascorbic acid bob – ascorbic acid dusk ascorbic acid never

  130. biaxin pills ink – albendazole bronze cytotec pills attendant

  131. florinef plenty – fludrocortisone pills wooden prevacid fever

  132. generic bisacodyl 5mg – buy bisacodyl paypal buy liv52 20mg online

  133. aciphex drug – reglan 10mg us domperidone us

  134. buy generic cotrimoxazole – order tobra 5mg without prescription tobra buy online

  135. buy zovirax generic – desogestrel 0.075mg without prescription buy duphaston 10mg sale

  136. order generic forxiga – purchase forxiga sale order generic acarbose 50mg

  137. buy generic griseofulvin over the counter – how to get dipyridamole without a prescription lopid ca

  138. buy dimenhydrinate 50 mg generic – prasugrel usa buy actonel 35 mg online cheap

  139. buy vasotec pills – doxazosin 2mg pills zovirax generic

  140. etodolac 600 mg generic – monograph online buy cilostazol 100mg over the counter

  141. feldene 20 mg for sale – buy generic feldene 20mg order generic rivastigmine 3mg

  142. nootropil 800 mg drug – buy generic nootropil 800mg cheap sinemet

  143. buy hydrea cheap – order robaxin sale oral methocarbamol

  144. buy divalproex generic – mefloquine online order buy topiramate

  145. disopyramide phosphate buy online – epivir brand buy generic thorazine over the counter

  146. cheap generic cyclophosphamide – vastarel canada trimetazidine sale

  147. order aldactone 25mg generic – epitol buy online buy revia 50mg pill

  148. buy cyclobenzaprine 15mg pill – where can i buy primaquine order enalapril without prescription

  149. zofran 4mg tablet – buy ropinirole cheap buy ropinirole sale

  150. ascorbic acid 500mg cheap – order compro generic buy prochlorperazine

  151. where can i purchase durex gel – order durex gel sale cheap xalatan

  152. cheap rogaine for sale – proscar sale buy propecia

  153. buy arava for sale – order generic risedronate 35 mg cheap generic cartidin

  154. order atenolol 100mg generic – sotalol 40 mg over the counter how to get coreg without a prescription

  155. order calan 120mg generic – valsartan brand cheap tenoretic sale

  156. atorvastatin order – buy atorlip for sale buy bystolic 20mg pills

  157. purchase lasuna generic – himcolin price himcolin where to buy

  158. purchase gasex for sale – order ashwagandha without prescription brand diabecon

  159. buy norfloxacin pills for sale – cheap confido buy confido pill

  160. speman for sale – cheap speman generic order fincar online

  161. order finax – finasteride tablets oral uroxatral

  162. hytrin pill – buy dapoxetine sale buy priligy 30mg generic

  163. order trileptal 600mg generic – purchase pirfenidone sale synthroid order

  164. buy generic imusporin over the counter – how to buy cyclosporine buy colcrys 0.5mg online cheap

  165. buy cheap lactulose – buy lactulose medication betahistine 16mg brand

  166. buy calcort sale – alphagan eye drops brimonidine medication

  167. buy besifloxacin online – buy sildamax online cheap sildamax tablet

  168. buy neurontin 600mg – azulfidine for sale buy azulfidine generic

  169. order probenecid 500 mg pills – tegretol drug tegretol online

  170. celecoxib 200mg drug – cheap urispas without prescription buy indocin tablets

  171. colospa 135mg us – pletal over the counter purchase cilostazol for sale

  172. diclofenac 50mg generic – buy aspirin 75mg sale order aspirin pill

  173. buy rumalaya paypal – shallaki price amitriptyline online buy

  174. buy mestinon paypal – mestinon 60 mg cheap order imuran 25mg

  175. where can i buy diclofenac – nimodipine without prescription buy nimodipine for sale

  176. lioresal us – piroxicam without prescription where can i buy piroxicam

  177. buy mobic generic – toradol ca order toradol generic

  178. periactin 4mg pills – brand tizanidine 2mg zanaflex generic

  179. oral artane – order trihexyphenidyl generic how to order emulgel

  180. order omnicef 300mg generic – cleocin price cleocin usa

  181. acticin us – purchase benzac order retin cream generic

  182. flagyl cheap – cenforce 50mg us cheap cenforce

TOP