Overview of the Accreditation of Foreign Manufacturers (FMA) in Japan All foreign manufacturers intending to manufacture drugs, quasi-drugs, medical devices, or drug substances in foreign

Registration of Cosmetics and Quasi-Drugs in Japan In Japan, cosmetics are regulated under Pharmaceutical and Medical Devices Law (PMDL, formerly Pharmaceutical Affairs Law) and they

Registration of imported cosmetics in china Foreign manufacturers of cosmetics interested in entering Chinese cosmetic market without a local subsidiary need to assign a Chinese

How Medical Devices are classified by FDA Overview FDA defines a medical device as any product that does not achieve its purposes by chemical action

Orphan Drugs in Japan MHLW holds jurisdiction over the Pharmaceutical Affairs Law and the MHLW makes orphan designation decisions on a case-by-case basis. The decision

Orphan drug designation on brazil In Brazil, a rare disease is the one affecting up to 65 people in every 100,000 individuals based on official