


Jan 2, 2018
OMN###Oman

Jan 1, 2018
LBN###Lebanon

Jan 1, 2018
EU###European Union

Jan 1, 2018
BGD###Bangladesh
Take The First Step Towards Medical Devices Registrations
Categories
Categories
- Africa (27)
- Asia (131)
- Australia and Oceania (92)
- Belgium (1)
- Brazil (4)
- Canada (45)
- Case Study (19)
- China (3)
- COFEPRIS (1)
- Consultant Post (7)
- COVID-19 (27)
- Denmark (1)
- Ethiopia (27)
- EU MDR/IVDR (99)
- Europe (176)
- FDA (285)
- IMDRF (10)
- India (4)
- Indonesia (1)
- IVD (2)
- Japan (1)
- Kazakhstan (9)
- Malaysia (6)
- MDCG (27)
- Mexico (1)
- MHRA (23)
- North America (350)
- Peru (2)
- Philippines (2)
- Poland (2)
- RegDesk News/Info (27)
- Russia (10)
- Saudi Arabia (23)
- Slovenia (1)
- South America (28)
- South Korea (2)
- switzerland (9)
- Taiwan (3)
- TGA (48)
- UK (12)
- Uncategorized (247)
- United States (221)
Tags
medical devices (442)
RegDesk (395)
Medical Device (378)
FDA (371)
guidance (256)
united states (180)
guidance RegDesk (165)
regulatory (147)
regulation (146)
mdr (135)
medical software (127)
United States of America (119)
Medical Devices RegDesk (111)
North America (108)
medical device regulations (107)
FDA guidance (94)
TGA (83)
regulations (78)
Australia (66)
Asia (59)
Europe (54)
fda medical devices (52)
Singapore (51)
Food and Drug Administration (51)
hsa (48)
RegDes (48)
health canada (47)
Canada (45)
USA (45)
EU (44)
guidelines (44)
COVID-19 (44)
MDCG (42)
software (41)
medical device grouping (39)
medicines (37)
Southeast Asia (36)
South Asia (35)
mhra (33)
requirements (30)
guidances (29)
EC (28)
Regulatory Authority (27)
Ethiopia (27)
Ethiopian FDA (27)
Ethiopian Food and Drug Authority (27)
EU MDR (26)
uk (24)
saudi arabia (23)
Medical Devices Ethiopia (23)
medical device registration (23)
Registration (22)
sfda (22)
artg (20)
medical device software (20)
Labeling (20)
clinical (20)
ivd (19)
EFDA (19)
IVDR (19)
Clinical Trials (18)
Cybersecurity (18)
European (16)
regulatory affairs (15)
Australian Register of Therapeutic Goods (15)
Pharma (15)
classification (15)
SaMD (15)
European Commission (14)
medical (14)
notified bodies (14)
India (14)
510k (14)
Regulatory Legislation (14)
therapeutic goods administration (14)
US (14)
UDI (14)
changes (14)
regdesk medical device (13)
Quality (13)
China (13)
Regulatory News (13)
EMA (13)
manufacturers (13)
de novo (12)
Africa (12)
IMDRF (12)
devices (12)
russia (12)
submissions (12)
Coronavirus (12)
Malaysia (11)
Medical Device Labeling (11)
Kazakhstan (11)
Brazil (11)
clinical trial (11)
healthcare (11)
Labelling (11)
Device (10)
manufacturing (10)
International (10)
Anvisa (10)
Drugs (10)
European Union (10)
Tests (9)
EU MDR and IVDR (9)
fda guidelines for medical devices (9)
medical device regulation (9)
Medical Device regulatory (9)
CDSCO (8)
swissmedic (8)
EUA (8)
inspections (8)
medical device labeling requirements (8)
Pharmaceuticals (8)
CFDA (8)
TGA news (8)
medical device submissions (8)
regulatory requirements (8)
software as a medical device (8)
technology (8)
Europe medical device regulations (8)
notification (7)
Recalls (7)
personalized medical devices (7)
incident reporting (7)
Update (7)
mda (7)
in vitro diagnostic (7)
Design Control (7)
medical device coordination group (7)
reprocessing (7)
advertising (7)
recall (7)
distribution (7)
Investigational Device Exemptions (7)
Switzerland (7)
IDE (7)
3D printing medical devices (7)
clinical evaluation (7)
ISO (7)
medical device guidance (7)
EU IVDR (7)
European Medical Device Regulations (7)
MedTech (7)
NDDA (7)
how to (6)
safer technologies program (6)
quality system (6)
Digital (6)
Turkey (6)
Compliance (6)
medicine (6)
risk (6)
cdrh (6)
covid (6)
Japan (6)
asca (6)
conformity assessment (6)
Infusion Pumps (6)
ppe (6)
human factors (6)
Pakistan (6)
eudamed (6)
Marketing (6)
Unique Device Identification (6)
submission (6)
surveillance (6)
medical devices. regulations (6)
technologies (6)
Canada medical device regulations (6)
draft guidance (6)
Saudi (5)
pma (5)
label (5)
application (5)
brexit (5)
eCopy (5)
In vitro diagnostics (5)
roszdravnadzor (5)
medical device manufacturers (5)
Russian (5)
covid-19 tests (5)
510 (k) (5)
quality system certification (5)
MDEL (5)
labels (5)
distributor (5)
safety (5)
conformity assessment bodies (5)
post market surveillance (5)
implementation (5)
in vitro (5)
Austrlia (5)
510(k) submission (5)
De Novo Classification (5)
Custom-made medical devices (5)
RegDesk (395)
Medical Device (378)
FDA (371)
guidance (256)
united states (180)
guidance RegDesk (165)
regulatory (147)
regulation (146)
mdr (135)
medical software (127)
United States of America (119)
Medical Devices RegDesk (111)
North America (108)
medical device regulations (107)
FDA guidance (94)
TGA (83)
regulations (78)
Australia (66)
Asia (59)
Europe (54)
fda medical devices (52)
Singapore (51)
Food and Drug Administration (51)
hsa (48)
RegDes (48)
health canada (47)
Canada (45)
USA (45)
EU (44)
guidelines (44)
COVID-19 (44)
MDCG (42)
software (41)
medical device grouping (39)
medicines (37)
Southeast Asia (36)
South Asia (35)
mhra (33)
requirements (30)
guidances (29)
EC (28)
Regulatory Authority (27)
Ethiopia (27)
Ethiopian FDA (27)
Ethiopian Food and Drug Authority (27)
EU MDR (26)
uk (24)
saudi arabia (23)
Medical Devices Ethiopia (23)
medical device registration (23)
Registration (22)
sfda (22)
artg (20)
medical device software (20)
Labeling (20)
clinical (20)
ivd (19)
EFDA (19)
IVDR (19)
Clinical Trials (18)
Cybersecurity (18)
European (16)
regulatory affairs (15)
Australian Register of Therapeutic Goods (15)
Pharma (15)
classification (15)
SaMD (15)
European Commission (14)
medical (14)
notified bodies (14)
India (14)
510k (14)
Regulatory Legislation (14)
therapeutic goods administration (14)
US (14)
UDI (14)
changes (14)
regdesk medical device (13)
Quality (13)
China (13)
Regulatory News (13)
EMA (13)
manufacturers (13)
de novo (12)
Africa (12)
IMDRF (12)
devices (12)
russia (12)
submissions (12)
Coronavirus (12)
Malaysia (11)
Medical Device Labeling (11)
Kazakhstan (11)
Brazil (11)
clinical trial (11)
healthcare (11)
Labelling (11)
Device (10)
manufacturing (10)
International (10)
Anvisa (10)
Drugs (10)
European Union (10)
Tests (9)
EU MDR and IVDR (9)
fda guidelines for medical devices (9)
medical device regulation (9)
Medical Device regulatory (9)
CDSCO (8)
swissmedic (8)
EUA (8)
inspections (8)
medical device labeling requirements (8)
Pharmaceuticals (8)
CFDA (8)
TGA news (8)
medical device submissions (8)
regulatory requirements (8)
software as a medical device (8)
technology (8)
Europe medical device regulations (8)
notification (7)
Recalls (7)
personalized medical devices (7)
incident reporting (7)
Update (7)
mda (7)
in vitro diagnostic (7)
Design Control (7)
medical device coordination group (7)
reprocessing (7)
advertising (7)
recall (7)
distribution (7)
Investigational Device Exemptions (7)
Switzerland (7)
IDE (7)
3D printing medical devices (7)
clinical evaluation (7)
ISO (7)
medical device guidance (7)
EU IVDR (7)
European Medical Device Regulations (7)
MedTech (7)
NDDA (7)
how to (6)
safer technologies program (6)
quality system (6)
Digital (6)
Turkey (6)
Compliance (6)
medicine (6)
risk (6)
cdrh (6)
covid (6)
Japan (6)
asca (6)
conformity assessment (6)
Infusion Pumps (6)
ppe (6)
human factors (6)
Pakistan (6)
eudamed (6)
Marketing (6)
Unique Device Identification (6)
submission (6)
surveillance (6)
medical devices. regulations (6)
technologies (6)
Canada medical device regulations (6)
draft guidance (6)
Saudi (5)
pma (5)
label (5)
application (5)
brexit (5)
eCopy (5)
In vitro diagnostics (5)
roszdravnadzor (5)
medical device manufacturers (5)
Russian (5)
covid-19 tests (5)
510 (k) (5)
quality system certification (5)
MDEL (5)
labels (5)
distributor (5)
safety (5)
conformity assessment bodies (5)
post market surveillance (5)
implementation (5)
in vitro (5)
Austrlia (5)
510(k) submission (5)
De Novo Classification (5)
Custom-made medical devices (5)