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” ]
best allergy pill for itching alternative allergy treatment options alternative allergy treatment options
sleeping tablets without a prescription oral provigil 200mg
prednisone 20mg pill order generic prednisone 20mg
can taking pills cause heartburn duricef 250mg canada
dermatologist prescribed acne cream buy retino gel for sale best acne treatment teenage guys
buy isotretinoin generic cheap accutane 10mg buy accutane generic
sleeping tablets without a prescription buy provigil 100mg pill
amoxicillin 250mg tablet amoxicillin where to buy brand amoxil 1000mg
cost azithromycin order azithromycin 250mg online buy azithromycin sale
buy gabapentin 100mg online cheap cheap gabapentin online
order azithromycin 500mg sale azipro 250mg over the counter azipro online buy
buy lasix 40mg online cheap lasix generic
cheap omnacortil sale order generic prednisolone 10mg prednisolone generic
buy prednisone sale deltasone 5mg generic
buy generic amoxicillin for sale amoxicillin price cheap amoxicillin 250mg
vibra-tabs over the counter buy vibra-tabs online
albuterol inhalator cost albuterol over the counter cheap albuterol 2mg
cheap amoxiclav buy augmentin 625mg for sale
purchase levothyroxine for sale buy synthroid 100mcg pills buy synthroid 75mcg for sale
order generic vardenafil 10mg order generic levitra
serophene us cheap clomid clomiphene tablet
rybelsus 14 mg for sale buy semaglutide without prescription buy semaglutide 14 mg online
order tizanidine 2mg generic buy tizanidine online zanaflex price
prednisone 40mg generic prednisone uk order deltasone 5mg for sale
generic rybelsus 14mg buy rybelsus 14mg for sale purchase rybelsus pills
buy absorica for sale buy isotretinoin cheap accutane 10mg uk
purchase albuterol albuterol inhalator usa brand ventolin inhalator
amoxil 1000mg ca amoxicillin 1000mg over the counter amoxil 250mg pill
augmentin 1000mg oral how to buy clavulanate how to get augmentin without a prescription
buy azithromycin online buy azithromycin 500mg buy zithromax 250mg
cheap levoxyl pill buy synthroid paypal levoxyl uk
omnacortil where to buy generic prednisolone 20mg buy generic omnacortil 10mg
clomid 100mg usa order clomiphene 100mg without prescription buy serophene without prescription
buy generic neurontin for sale buy gabapentin 600mg generic buy gabapentin online cheap
buy furosemide tablets furosemide 100mg over the counter order lasix 40mg for sale
viagra 50mg viagra pills 25mg order viagra 100mg sale
monodox price acticlate brand order acticlate online cheap
semaglutide price buy semaglutide 14 mg sale order semaglutide 14mg for sale
free blackjack games online poker sites free poker online
buy generic vardenafil for sale levitra 20mg pills order generic vardenafil
buy lyrica 75mg sale order pregabalin 75mg sale order pregabalin 150mg
cheap hydroxychloroquine cheap hydroxychloroquine 400mg plaquenil brand
buy triamcinolone online triamcinolone 4mg price triamcinolone 10mg generic
tadalafil oral buying cialis cheap cialis 40mg uk
clarinex buy online buy desloratadine 5mg generic purchase desloratadine
cenforce tablet cenforce 100mg without prescription purchase cenforce without prescription
claritin 10mg pills buy claritin 10mg online cheap buy generic claritin over the counter
aralen tablet chloroquine online aralen sale
dapoxetine 90mg cheap misoprostol for sale order misoprostol
order glucophage 1000mg for sale glucophage 500mg canada glucophage 1000mg for sale
orlistat 60mg without prescription buy diltiazem 180mg pill order diltiazem sale
order amlodipine 10mg pills cheap amlodipine 5mg buy amlodipine sale
zovirax 800mg sale buy zovirax 400mg generic buy allopurinol 100mg
purchase prinivil without prescription zestril 10mg brand lisinopril uk
buy crestor 10mg online purchase crestor generic zetia medication
prilosec 20mg uk prilosec 20mg us buy prilosec online cheap
domperidone 10mg without prescription order domperidone for sale buy sumycin 250mg generic
cheap lopressor buy generic metoprolol online order metoprolol generic
buy cyclobenzaprine 15mg sale buy flexeril online order ozobax pills
oral ketorolac how to get ketorolac without a prescription buy colchicine pills for sale
buy atenolol 50mg tenormin online buy tenormin generic
buy medrol pill buy depo-medrol us buy methylprednisolone 4 mg online
order inderal 10mg how to buy propranolol purchase plavix pills
academic writing uk professional research paper writers write thesis
methotrexate 2.5mg usa order warfarin generic coumadin cost
purchase meloxicam generic buy celebrex without a prescription order celecoxib 200mg
purchase reglan for sale losartan 25mg without prescription hyzaar price
tamsulosin sale tamsulosin for sale celecoxib 100mg generic
order esomeprazole 40mg generic esomeprazole drug buy topamax 200mg generic
ondansetron medication buy generic zofran over the counter where can i buy spironolactone
purchase sumatriptan generic order levaquin 250mg pills order levaquin 250mg pill
zocor for sale order zocor 20mg sale order valtrex 1000mg pill
purchase avodart for sale buy cheap generic ranitidine buy zantac online cheap
ampicillin ca buy amoxil for sale how to get amoxicillin without a prescription
propecia 5mg pill order forcan generic generic diflucan
cipro oral – cheap augmentin order augmentin 375mg pills
purchase cipro without prescription – buy cipro 500mg generic clavulanate usa
buy flagyl online – order cleocin 300mg sale azithromycin 250mg us
oral ciprofloxacin – doxycycline pill buy erythromycin pill
valacyclovir 1000mg cheap – order nemasole buy acyclovir cheap
stromectol oral – sumycin medication tetracycline generic
order metronidazole – azithromycin 250mg us zithromax 500mg oral
acillin without prescription buy generic doxycycline online order amoxicillin without prescription
buy lasix 40mg – where to buy warfarin without a prescription capoten cheap
buy cheap glucophage – glucophage online order purchase lincomycin generic
order zidovudine 300mg pills – purchase glycomet for sale zyloprim pill
order clozaril 100mg – famotidine without prescription pepcid brand
seroquel sale – buy cheap generic sertraline cheap eskalith tablets
clomipramine 50mg tablet – anafranil 50mg drug buy generic sinequan 25mg
atarax online order – order sarafem 40mg pills endep 25mg drug
buy generic amoxicillin – how to get erythromycin without a prescription cheap ciprofloxacin
buy clavulanate pills – purchase ampicillin cipro canada
buy cleocin 300mg without prescription – where can i buy cefixime buy generic chloromycetin over the counter
zithromax 500mg pill – purchase ofloxacin without prescription cheap ciplox 500mg
ivermectin oral – ivermectin 12mg pills purchase cefaclor sale
generic albuterol 4mg – buy promethazine 25mg buy theophylline medication
buy clarinex 5mg pill – buy desloratadine generic order albuterol generic
methylprednisolone online – methylprednisolone drug astelin 10ml nasal spray
buy micronase generic – purchase glipizide online buy dapagliflozin pills for sale
order generic repaglinide – jardiance 25mg sale order jardiance generic
order generic glycomet 1000mg – buy losartan generic where can i buy acarbose
purchase lamisil – fluconazole price buy cheap generic griseofulvin
where can i buy semaglutide – order semaglutide online DDAVP cost
brand nizoral – buy ketoconazole medication sporanox 100mg uk
order famvir 500mg sale – famciclovir 500mg for sale brand valcivir
digoxin 250mg canada – buy dipyridamole without a prescription purchase lasix pills
microzide 25 mg ca – order norvasc 10mg sale cost zebeta
buy metoprolol 50mg pills – order lopressor without prescription adalat us
order nitroglycerin pills – buy generic combipres online valsartan online
rosuvastatin pills reference – ezetimibe online fashion caduet buy dispose
buy zocor 20mg pills – atorvastatin everyone lipitor better
viagra professional bile – super kamagra ill levitra oral jelly artist
priligy amid – suhagra among cialis with dapoxetine smooth
cenforce online preserve – kamagra online throb brand viagra online thorough
brand cialis retire – brand levitra castle penisole nanny
cialis soft tabs pills waist – cialis oral jelly together viagra oral jelly online sea
brand cialis date – brand levitra uneasy penisole beauty
cialis soft tabs pills ward – tadarise pills occasion viagra oral jelly online exact
cenforce online attack – levitra professional online tool brand viagra pills pool
acne medication night – acne medication column acne treatment madness
asthma treatment british – asthma medication cell asthma treatment sofa
uti antibiotics grasp – uti antibiotics worst treatment for uti wine
prostatitis pills trick – prostatitis pills nature prostatitis pills council
valacyclovir attention – valacyclovir pills vanish valacyclovir online suit
claritin pills classroom – claritin pills apply claritin pills joy
dapoxetine mistress – priligy distract priligy mistress
claritin pills circumstance – loratadine praise loratadine medication ernest
promethazine manner – promethazine weep promethazine friend
ascorbic acid bob – ascorbic acid dusk ascorbic acid never
biaxin pills ink – albendazole bronze cytotec pills attendant
florinef plenty – fludrocortisone pills wooden prevacid fever
generic bisacodyl 5mg – buy bisacodyl paypal buy liv52 20mg online
aciphex drug – reglan 10mg us domperidone us
buy generic cotrimoxazole – order tobra 5mg without prescription tobra buy online
buy zovirax generic – desogestrel 0.075mg without prescription buy duphaston 10mg sale
order generic forxiga – purchase forxiga sale order generic acarbose 50mg
buy generic griseofulvin over the counter – how to get dipyridamole without a prescription lopid ca
buy dimenhydrinate 50 mg generic – prasugrel usa buy actonel 35 mg online cheap
buy vasotec pills – doxazosin 2mg pills zovirax generic
etodolac 600 mg generic – monograph online buy cilostazol 100mg over the counter
feldene 20 mg for sale – buy generic feldene 20mg order generic rivastigmine 3mg
nootropil 800 mg drug – buy generic nootropil 800mg cheap sinemet
buy hydrea cheap – order robaxin sale oral methocarbamol
buy divalproex generic – mefloquine online order buy topiramate
disopyramide phosphate buy online – epivir brand buy generic thorazine over the counter
cheap generic cyclophosphamide – vastarel canada trimetazidine sale
order aldactone 25mg generic – epitol buy online buy revia 50mg pill
buy cyclobenzaprine 15mg pill – where can i buy primaquine order enalapril without prescription
zofran 4mg tablet – buy ropinirole cheap buy ropinirole sale
ascorbic acid 500mg cheap – order compro generic buy prochlorperazine
where can i purchase durex gel – order durex gel sale cheap xalatan
cheap rogaine for sale – proscar sale buy propecia
buy arava for sale – order generic risedronate 35 mg cheap generic cartidin
order atenolol 100mg generic – sotalol 40 mg over the counter how to get coreg without a prescription
order calan 120mg generic – valsartan brand cheap tenoretic sale
atorvastatin order – buy atorlip for sale buy bystolic 20mg pills
purchase lasuna generic – himcolin price himcolin where to buy
purchase gasex for sale – order ashwagandha without prescription brand diabecon
buy norfloxacin pills for sale – cheap confido buy confido pill
speman for sale – cheap speman generic order fincar online
order finax – finasteride tablets oral uroxatral
hytrin pill – buy dapoxetine sale buy priligy 30mg generic
order trileptal 600mg generic – purchase pirfenidone sale synthroid order
buy generic imusporin over the counter – how to buy cyclosporine buy colcrys 0.5mg online cheap
buy cheap lactulose – buy lactulose medication betahistine 16mg brand
buy calcort sale – alphagan eye drops brimonidine medication
buy besifloxacin online – buy sildamax online cheap sildamax tablet
buy neurontin 600mg – azulfidine for sale buy azulfidine generic
order probenecid 500 mg pills – tegretol drug tegretol online
celecoxib 200mg drug – cheap urispas without prescription buy indocin tablets
colospa 135mg us – pletal over the counter purchase cilostazol for sale
diclofenac 50mg generic – buy aspirin 75mg sale order aspirin pill
buy rumalaya paypal – shallaki price amitriptyline online buy
buy mestinon paypal – mestinon 60 mg cheap order imuran 25mg
where can i buy diclofenac – nimodipine without prescription buy nimodipine for sale
lioresal us – piroxicam without prescription where can i buy piroxicam
buy mobic generic – toradol ca order toradol generic
periactin 4mg pills – brand tizanidine 2mg zanaflex generic
oral artane – order trihexyphenidyl generic how to order emulgel
order omnicef 300mg generic – cleocin price cleocin usa
acticin us – purchase benzac order retin cream generic
flagyl cheap – cenforce 50mg us cheap cenforce