Registration
Allocate your resources wisely and use external experienced registration resources when expanding your global business. MMS track record covers tens of EU CE-certifications and sales approvals to over 30 different countries outside EU. Below just a few examples:
USA
U.S. Food and Drug Administration
Classification
I, II, III
Validity
Unlimited, annual device listing and establishment registration needed
Canada
Health Canada
Classification
I, II, III, IV
Validity
Unlimited
Brazil
ANVISA Brazilian Health Regulatory Agency
Classification
I, II, III, IV
Validity
ANVISA class I – II notlimited,
class III – IV 5 years
INMETRO 5 years
Australia
TGA Therapeutic Goods Administration
Classification
I, Is, Im, IIa, IIb,III
s = sterile, m=measurement
Validity
Unlimited
Japan
Pharmaceuticals and Medical Device Agency
Classification
I, II, II controlled, III, IV
Validity
Unlimited
China
NMPA National Medical Products Administration, previous CFDA
Classification
I, II, III
Validity
5 years
Indonesia
NA-DFC National Agency of Drug and Food Control
Classification
I, II, III
Validity
2-5 years depending on the validity period of the Letter of Authorization
Malaysia
MDA Medical Device Authority of Health Malaysia
Classification
A, B, C, D
Validity
5 years
South-Korea
MFDS Ministry of Food and Drug Safety
Classification
I, II, III, IV
Validity
Unlimited
Mexico
COFEPRIS Federal Comission for the Protection against Sanitary Risk
Classification
I low risk, I, II, III
Validity
5 years
India
CDSCO Central Drugs Standard Control Organisation
Classification
A, B, C, D
Validity
Unlimited
South-Africa
SAHPRA South African Health Products Regulatory Authority
Classification
A, B, C, D
Validity
3 years
Taiwan
TFDA Taiwan Food and Drug Administration
Classification
I, II, III
Validity
5 years
Russia
RZN Roszdravnadzor
Classification
I, IIa, IIb, III
Validity
5 years
