We offer you solutions for your business with our deep expertise in regulations and reimbursement system necessary
for manufacturing, importing and sales of medical device, food, cosmetic and drug.
FDA(Food and Drug Administration) is the national health authority to protect American consumers and the prinipais to operate National Health Law. The food we eat is safe, hygienic and cosmetics we use are safe and effective medical devices...
CFDA is the national health authority to protect Chinese consumers and the principals to operate National Health Law. Draft laws, regulations and rules and policy plans on the administration and supervision of food safety, drugs medical devics and ...
The principal point of CE marking is to provide a 'level playing field' of market requirements across the European Community. Effectively this remove varriers to trade throughout the Eurropean Economic Area, allowing companies free access to markets in...
We guarantee the high-quality services. When manufacture of importer/exporter submits allocation for manufacturing of importing/exporting business approval of medical device, the manufacturer or importer/exporter should simultaneously submit...
The Summary Technical Document (STED) format for regulatory submissions is a harmonized submission format developed by the Global Harmonization Task Force (GHTF), a voluntary partnership of government and industry representatives...
Legislation may seem complicated, but we are trying to make it easy for you. Our aim is to answer all your questions, eliminate all concerns and help you make an informed decision, If you would like a consultation or an offer for our services...
Welcome to visit K-GMP Co., Ltd. We specialize in assistance with obtaining MFDS regulations and GMP certificates in medical devices.
K-GMP provides FDA, CFDA, CE, Registration, U.S. Agent, Compliance Assistance for U.S. and Non-U.S. Companies in the Food and Beverage, Medical Device, Drug, and Cosmetics industries.
We precisely follow legislated GMP procedure in order that medical device companies have proper GMP certificates and guidelines that correspond with their legislation.
K-GMP provides you intensive suppor for MFDS registration and compliance assistance for domestic and international companies related to medical device industries.