This chart lists the pharmaceutical, medical and related regulatory authorities of MENA regulations countries along with links to their relevant websites.
Categories
Categories
- ACTD (1)
- Africa (43)
- AIaMD (2)
- ANMAT (1)
- Argentina (1)
- ARTG (2)
- Asia (239)
- Singapore (47)
- Australia (53)
- Australia and Oceania (130)
- Austria (1)
- Bahrain (7)
- BASG (1)
- Belgium (1)
- BfArM (18)
- Brazil (22)
- ANVISA (1)
- Canada (71)
- Case Study (6)
- CBRN (1)
- CDC (1)
- CDRH (11)
- CDSCO (8)
- China (6)
- CHMP (1)
- CLIA (1)
- COFEPRIS (1)
- Consultant Post (7)
- COVID-19 (34)
- Czech Republic (1)
- Denmark (2)
- DHSC (1)
- DRAP (13)
- DRCPFA (1)
- EDA (15)
- Egypt (15)
- Ethiopia (27)
- EU (39)
- EU MDR/IVDR (129)
- EUA (1)
- Europe (270)
- European Commission (3)
- European Union (3)
- FDA (682)
- Germany (18)
- GMDN (1)
- Great Britain (13)
- GRTPNZ (3)
- GSPR (1)
- Guatemala (1)
- Health Canada (19)
- Healthcare (2)
- HIE (1)
- Hong Kong (2)
- HPRA (6)
- HSA (30)
- IMDRF (25)
- India (12)
- Indonesia (1)
- Ireland (6)
- ISO Standards (1)
- IVD (2)
- Japan (1)
- Kazakhstan (9)
- Latvia (1)
- LRN (1)
- Malaysia (27)
- MDA (8)
- MDACs (2)
- MDCG (86)
- MDR (2)
- MDSAP (2)
- Medical Device Regulation Resources (1)
- Medical Devices (3)
- Medsafe (8)
- Mexico (2)
- MHRA (63)
- MoU (2)
- NATA (2)
- New Zealand (8)
- NHRA (6)
- NMPA (2)
- North America (457)
- Northern Ireland (1)
- NPAAC (3)
- orthopaedics (2)
- Pakistan (13)
- PDUFA (3)
- Peru (2)
- PHEs (1)
- Philippines (3)
- Poland (2)
- QMS (2)
- RCPA (1)
- RegDesk News/Info (26)
- RIMS (1)
- Russia (10)
- SAHPRA (4)
- SaMD (2)
- Saudi Arabia (53)
- Serbia (1)
- SFDA (10)
- SFHS (2)
- Slovenia (1)
- South Africa (5)
- South America (28)
- South Korea (2)
- Southeast Asia (1)
- State Agency of Medicines of Latvia (1)
- Swissmedic (10)
- switzerland (30)
- Taiwan (3)
- Tanzania (3)
- TGA (138)
- Thailand (2)
- TMDA (3)
- TMMDA (1)
- Turkey (6)
- Turkish national regulating authority (1)
- Turkish Regulatory Authority (1)
- UK (40)
- Uncategorized (471)
- United Kingdom (16)
- United States (618)
- URRA (4)
- USA (4)
- USFDA (10)
Tags
medical devices (946)
RegDesk (758)
FDA (638)
Medical Device (552)
guidance RegDesk (432)
guidance (410)
Medical Devices RegDesk (361)
united states (326)
FDA guidance (300)
United States of America (242)
North America (224)
medical device regulations (213)
mdr (186)
fda medical devices (184)
regulation (174)
regulatory (168)
Food and Drug Administration (167)
RegDes (162)
TGA (151)
medical software (144)
Singapore (133)
Asia (131)
hsa (125)
guidances (111)
USA (101)
Healthcare Products (98)
Europe (97)
South Asia (95)
medical (95)
MDCG (90)
software (88)
Southeast Asia (88)
regulations (86)
EU (81)
Australia (80)
RIMS (77)
health canada (68)
regdesk medical device (61)
guidelines (60)
mhra (59)
Clinical Trials (58)
medical device registration (58)
COVID-19 (58)
Canada (56)
medicines (56)
medical device grouping (55)
healthcare (52)
Health Sciences Authority (49)
saudi arabia (48)
medical device regulation (48)
Austalia (48)
sfda (47)
European (47)
EU MDR (46)
modifications (46)
TGA news (45)
PCCP (45)
regulatory affairs (42)
IVDR (42)
ivd (41)
uk (40)
Australia Register of Therapeutic Goods (40)
510k (39)
Questions (39)
European Medical Device Regulations (36)
clinical (35)
SaMD (34)
requirements (34)
Regulatory Approval (34)
artg (32)
IMDRF (31)
Malaysia (30)
EC (30)
USFDA (30)
Regulatory Compliance (29)
Brazil (28)
Regulatory Authority (27)
Anvisa (27)
Ethiopia (27)
Africa (27)
Ethiopian FDA (27)
Ethiopian Food and Drug Authority (27)
Europe medical device regulations (26)
cdrh (25)
Tests (25)
clinical trial (25)
Clinical Research (25)
Labeling (24)
Registration (23)
Medical Devices Ethiopia (23)
Pakistan (22)
Cybersecurity (22)
swissmedic (22)
clinical investigations (22)
mda (21)
MHRA Guidance (21)
UDI (20)
notified bodies (20)
medical device software (20)
IVDs (19)
EFDA (19)
Saudi FDA (19)
Patient safety (19)
Switzerland (18)
classification (18)
conformity assessment (17)
AI Medical Devices (17)
Device Classification (17)
Quality (16)
regulatory guidance (16)
Digital Health (16)
European Union (16)
medtech europe (16)
changes (16)
cybersecuirty (16)
Australian Register of Therapeutic Goods (16)
medical device regulaions (16)
Pharma (15)
Drugs (15)
Product Registration (15)
ANVISA regulations (15)
Brazil medical devices (15)
ANVISA news (15)
combination products (15)
therapeutic goods administration (15)
Regulatory Legislation (14)
US (14)
manufacturers (14)
European Commission (14)
Clinical Studies (14)
USFDA Guidelines (14)
India (13)
China (13)
Regulatory News (13)
EMA (13)
de novo (13)
MedTech (13)
NHRA (13)
medical products (13)
Recalls (13)
medical device authority malaysia (13)
IDE (13)
clinical evaluation (13)
FDA approval (13)
DRAP (13)
russia (12)
manufacturing (12)
regulatory requirements (12)
devices (12)
BfArM (12)
submissions (12)
Coronavirus (12)
safety (12)
Pre-Market Approval (12)
healthcare technology (12)
GCP (12)
Turkey (11)
Kazakhstan (11)
bahrain (11)
Germany (11)
Labelling (11)
legacy devices (11)
FD&C Act (11)
Medical Device Labeling (11)
sahpra (11)
review clock (11)
Establishment Licensing (11)
Device (10)
International (10)
ISO (10)
EU IVDR (10)
medical device classification (10)
fda guidelines for medical devices (10)
innovation (10)
eudamed (10)
medical device submissions (10)
AI (10)
medical device regulations guidance (10)
Patient Rights (10)
Medical Ethics (10)
EU MDR and IVDR (9)
EUMDR (9)
artificial intelligence (9)
Medical Device regulatory (9)
Public health (9)
monitoring (9)
EUA (9)
Tanzania (9)
incident reporting (9)
medical device advertising (9)
Medical device marketing (9)
Q-Submission (9)
medical imaging devices (9)
United KingdomUK (9)
VMSR (9)
Product Recalls (9)
CDSCO (8)
CFDA (8)
brazil medical device classification (8)
software as a medical device (8)
technology (8)
Health Canada Guidance (8)
quality system (8)
inspections (8)
surveillance (8)
CABs (8)
personalized medical devices (8)
Clinical Evidence (8)
medical device labeling requirements (8)
medical device changes (8)
overview (8)
post market surveillance (8)
human factors (8)
21 CFR (8)
Photobiomodulation Devices (8)
Neonatal Product Development (8)
SFDA guidance (8)
qms (8)
Medical Device Improvement (8)
Regulatory Intelligence (8)
TPLC (8)
PPI (8)
Egypt (7)
Compliance (7)
Pharmaceuticals (7)
Medical Device Industry (7)
Unique Device Identification (7)
pma (7)
3D printing medical devices (7)
medical device guidance (7)
medicine (7)
HPRA (7)
medical device coordination group (7)
submission (7)
risk management (7)
advertising (7)
recall (7)
distribution (7)
medical devices. regulations (7)
biocompatibility (7)
510(k) submission (7)
virus (7)
reprocessing (7)
adverse event reporting (7)
NDDA (7)
notification (7)
Update (7)
essential principles (7)
in vitro diagnostic (7)
exemption (7)
AI Medical Software (7)
Big Data (7)
TMDA (7)
Health Canada Guidelines (7)
Investigational Device Exemptions (7)
Design Control (7)
De Novo Classification (7)
Therapeutic Goods (7)
Life Cycle Approach (7)
Software Medical Devices (7)
Medicines Act (7)
IVD Medical Devices (7)
Biological Products (7)
Saudi (6)
Marketing (6)
Pharmacovigilance (6)
pharmaceutical (6)
class 1 medical device (6)
machine learning (6)
Canada medical device regulations (6)
draft guidance (6)
FSCA (6)
health products (6)
risk (6)
asca (6)
risk classification (6)
drug device (6)
technologies (6)
implementation (6)
third party review (6)
dental (6)
Digital (6)
covid (6)
ppe (6)
Reclassification (6)
conformity assessment bodies (6)
in vitro (6)
safer technologies program (6)
mutations (6)
advertising rules (6)
advertising regulations (6)
Big Data-Based Medical Devices (6)
resubmission (6)
how to (6)
sterilization (6)
Reporting Requirements (6)
Application process (6)
Design (6)
Infusion Pumps (6)
clinical data (6)
Medical Technology (6)
Fast-Track Process (6)
Healthcare Innovation (6)
Good Clinical Practices (6)
Recall PRocedure (6)
FD&C (6)
Specific Aspects (6)
Pharmacy Profession Law (6)
Animal Health (6)
Waste Management (6)
Public Safety (6)
Health Protection (6)
Member States (6)
JAT (6)
Excluded Software (6)
MedSafe (5)
In vitro diagnostics (5)
quality assurance (5)
Japan (5)
Thailand (5)
mexico (5)
brexit (5)
COFEPRIS (5)
medical device manufacturers (5)
Ireland (5)
class 3 medical device (5)
application (5)
clinical guidelines (5)
notified body (5)
medicinal products (5)
mdd (5)
labels (5)
label (5)
roszdravnadzor (5)
Russian (5)
covid-19 tests (5)
Custom-made medical devices (5)
Substantial Equivalence (5)
eCopy (5)
Clinical Investigation (5)
510 (k) (5)
MDEL (5)
Medical Device Establishment License (5)
changes to existing devices (5)
alternatives (5)
510(k) notification (5)
MRDD (5)
Medical Device License (5)
Medical Device Recalls (5)
quality system certification (5)
medical device manufacturing (5)
reporting (5)
distributor (5)
Austrlia (5)
Medical Device Compliance (5)
Pathology Peer Review (5)
x-ray (5)
x-ray imaging devices (5)
site master file preperation (5)
TGA Compliance (5)
Australian Medical Devices: (5)
GSPR (5)
Fast Track Approval (5)
Adverse Events (5)
Clinical study (5)
Real World Evidence (5)
In-House IVDs (5)
Diversity (5)
Patient Preference (5)
Chemical Analysis (5)
Biocompatibility Assessment (5)
Chemical Characterization (5)
Electronic Records (5)
Electronic Systems (5)
Electronic Signatures (5)
RegDesk (758)
FDA (638)
Medical Device (552)
guidance RegDesk (432)
guidance (410)
Medical Devices RegDesk (361)
united states (326)
FDA guidance (300)
United States of America (242)
North America (224)
medical device regulations (213)
mdr (186)
fda medical devices (184)
regulation (174)
regulatory (168)
Food and Drug Administration (167)
RegDes (162)
TGA (151)
medical software (144)
Singapore (133)
Asia (131)
hsa (125)
guidances (111)
USA (101)
Healthcare Products (98)
Europe (97)
South Asia (95)
medical (95)
MDCG (90)
software (88)
Southeast Asia (88)
regulations (86)
EU (81)
Australia (80)
RIMS (77)
health canada (68)
regdesk medical device (61)
guidelines (60)
mhra (59)
Clinical Trials (58)
medical device registration (58)
COVID-19 (58)
Canada (56)
medicines (56)
medical device grouping (55)
healthcare (52)
Health Sciences Authority (49)
saudi arabia (48)
medical device regulation (48)
Austalia (48)
sfda (47)
European (47)
EU MDR (46)
modifications (46)
TGA news (45)
PCCP (45)
regulatory affairs (42)
IVDR (42)
ivd (41)
uk (40)
Australia Register of Therapeutic Goods (40)
510k (39)
Questions (39)
European Medical Device Regulations (36)
clinical (35)
SaMD (34)
requirements (34)
Regulatory Approval (34)
artg (32)
IMDRF (31)
Malaysia (30)
EC (30)
USFDA (30)
Regulatory Compliance (29)
Brazil (28)
Regulatory Authority (27)
Anvisa (27)
Ethiopia (27)
Africa (27)
Ethiopian FDA (27)
Ethiopian Food and Drug Authority (27)
Europe medical device regulations (26)
cdrh (25)
Tests (25)
clinical trial (25)
Clinical Research (25)
Labeling (24)
Registration (23)
Medical Devices Ethiopia (23)
Pakistan (22)
Cybersecurity (22)
swissmedic (22)
clinical investigations (22)
mda (21)
MHRA Guidance (21)
UDI (20)
notified bodies (20)
medical device software (20)
IVDs (19)
EFDA (19)
Saudi FDA (19)
Patient safety (19)
Switzerland (18)
classification (18)
conformity assessment (17)
AI Medical Devices (17)
Device Classification (17)
Quality (16)
regulatory guidance (16)
Digital Health (16)
European Union (16)
medtech europe (16)
changes (16)
cybersecuirty (16)
Australian Register of Therapeutic Goods (16)
medical device regulaions (16)
Pharma (15)
Drugs (15)
Product Registration (15)
ANVISA regulations (15)
Brazil medical devices (15)
ANVISA news (15)
combination products (15)
therapeutic goods administration (15)
Regulatory Legislation (14)
US (14)
manufacturers (14)
European Commission (14)
Clinical Studies (14)
USFDA Guidelines (14)
India (13)
China (13)
Regulatory News (13)
EMA (13)
de novo (13)
MedTech (13)
NHRA (13)
medical products (13)
Recalls (13)
medical device authority malaysia (13)
IDE (13)
clinical evaluation (13)
FDA approval (13)
DRAP (13)
russia (12)
manufacturing (12)
regulatory requirements (12)
devices (12)
BfArM (12)
submissions (12)
Coronavirus (12)
safety (12)
Pre-Market Approval (12)
healthcare technology (12)
GCP (12)
Turkey (11)
Kazakhstan (11)
bahrain (11)
Germany (11)
Labelling (11)
legacy devices (11)
FD&C Act (11)
Medical Device Labeling (11)
sahpra (11)
review clock (11)
Establishment Licensing (11)
Device (10)
International (10)
ISO (10)
EU IVDR (10)
medical device classification (10)
fda guidelines for medical devices (10)
innovation (10)
eudamed (10)
medical device submissions (10)
AI (10)
medical device regulations guidance (10)
Patient Rights (10)
Medical Ethics (10)
EU MDR and IVDR (9)
EUMDR (9)
artificial intelligence (9)
Medical Device regulatory (9)
Public health (9)
monitoring (9)
EUA (9)
Tanzania (9)
incident reporting (9)
medical device advertising (9)
Medical device marketing (9)
Q-Submission (9)
medical imaging devices (9)
United KingdomUK (9)
VMSR (9)
Product Recalls (9)
CDSCO (8)
CFDA (8)
brazil medical device classification (8)
software as a medical device (8)
technology (8)
Health Canada Guidance (8)
quality system (8)
inspections (8)
surveillance (8)
CABs (8)
personalized medical devices (8)
Clinical Evidence (8)
medical device labeling requirements (8)
medical device changes (8)
overview (8)
post market surveillance (8)
human factors (8)
21 CFR (8)
Photobiomodulation Devices (8)
Neonatal Product Development (8)
SFDA guidance (8)
qms (8)
Medical Device Improvement (8)
Regulatory Intelligence (8)
TPLC (8)
PPI (8)
Egypt (7)
Compliance (7)
Pharmaceuticals (7)
Medical Device Industry (7)
Unique Device Identification (7)
pma (7)
3D printing medical devices (7)
medical device guidance (7)
medicine (7)
HPRA (7)
medical device coordination group (7)
submission (7)
risk management (7)
advertising (7)
recall (7)
distribution (7)
medical devices. regulations (7)
biocompatibility (7)
510(k) submission (7)
virus (7)
reprocessing (7)
adverse event reporting (7)
NDDA (7)
notification (7)
Update (7)
essential principles (7)
in vitro diagnostic (7)
exemption (7)
AI Medical Software (7)
Big Data (7)
TMDA (7)
Health Canada Guidelines (7)
Investigational Device Exemptions (7)
Design Control (7)
De Novo Classification (7)
Therapeutic Goods (7)
Life Cycle Approach (7)
Software Medical Devices (7)
Medicines Act (7)
IVD Medical Devices (7)
Biological Products (7)
Saudi (6)
Marketing (6)
Pharmacovigilance (6)
pharmaceutical (6)
class 1 medical device (6)
machine learning (6)
Canada medical device regulations (6)
draft guidance (6)
FSCA (6)
health products (6)
risk (6)
asca (6)
risk classification (6)
drug device (6)
technologies (6)
implementation (6)
third party review (6)
dental (6)
Digital (6)
covid (6)
ppe (6)
Reclassification (6)
conformity assessment bodies (6)
in vitro (6)
safer technologies program (6)
mutations (6)
advertising rules (6)
advertising regulations (6)
Big Data-Based Medical Devices (6)
resubmission (6)
how to (6)
sterilization (6)
Reporting Requirements (6)
Application process (6)
Design (6)
Infusion Pumps (6)
clinical data (6)
Medical Technology (6)
Fast-Track Process (6)
Healthcare Innovation (6)
Good Clinical Practices (6)
Recall PRocedure (6)
FD&C (6)
Specific Aspects (6)
Pharmacy Profession Law (6)
Animal Health (6)
Waste Management (6)
Public Safety (6)
Health Protection (6)
Member States (6)
JAT (6)
Excluded Software (6)
MedSafe (5)
In vitro diagnostics (5)
quality assurance (5)
Japan (5)
Thailand (5)
mexico (5)
brexit (5)
COFEPRIS (5)
medical device manufacturers (5)
Ireland (5)
class 3 medical device (5)
application (5)
clinical guidelines (5)
notified body (5)
medicinal products (5)
mdd (5)
labels (5)
label (5)
roszdravnadzor (5)
Russian (5)
covid-19 tests (5)
Custom-made medical devices (5)
Substantial Equivalence (5)
eCopy (5)
Clinical Investigation (5)
510 (k) (5)
MDEL (5)
Medical Device Establishment License (5)
changes to existing devices (5)
alternatives (5)
510(k) notification (5)
MRDD (5)
Medical Device License (5)
Medical Device Recalls (5)
quality system certification (5)
medical device manufacturing (5)
reporting (5)
distributor (5)
Austrlia (5)
Medical Device Compliance (5)
Pathology Peer Review (5)
x-ray (5)
x-ray imaging devices (5)
site master file preperation (5)
TGA Compliance (5)
Australian Medical Devices: (5)
GSPR (5)
Fast Track Approval (5)
Adverse Events (5)
Clinical study (5)
Real World Evidence (5)
In-House IVDs (5)
Diversity (5)
Patient Preference (5)
Chemical Analysis (5)
Biocompatibility Assessment (5)
Chemical Characterization (5)
Electronic Records (5)
Electronic Systems (5)
Electronic Signatures (5)