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