Australia Therapeutic Goods Administration (TGA), a federal drug authority which is subordinate to Australia Ministry of Health, provides a framework for a risk management approach that allows the Australian community to h***e timely access to therapeutic goods which are c***istently safe, effective and of high quality. TGA Registration carry out a range of asses***ent and monitoring activities to ensure therapeutic goods ***ailable in Australiaare of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.
The meaning of TGA certification:
It is known to all that the strict management of Australian drug production and import is widely recognized as one of the countries of strictest and most difficult to enter the market. TGA certification, GMP certification of Australian government, enjoys a high reputation internationally. Getting the TGA certification means the company is recognized by Australian government and its PIC/S members, England, France, Germany, Austria, Italian, Canada, Czechoslovakia, Finland, Greek, Iceland, Belgium, Denmark, Sweden, Singapore and the Netherlands on quality system and production environment facilities. After getting TGA certification, company can apply for production registration, as well as sub-contract production of some countries. TGA certification plays an important role in international market development of the company.
The supervision of therapeutic goods of TGA registration focuses on these following three aspects:
1.Asses***ent for goods before entering the market. All the drugs and medical devices must do the TGA registration before entering the market in order to assess risk.
2.Permission of pharmaceutical factory. Australian pharmaceutical manufacturer must get TGA and GMP certification.
3.Later supervision of the market. TGA has the right to sample and test the drugs on the market so that it can ensure it’s quality and standard.
O***unda medical device c***ulting organization (Guangzhou, Beijing, Shanghai, Suzhou, Shenzhen and Jinan), investing in China from Canada, is professionally engaged in medical device regulation c***ulting, medical device registered agent, medical device management system certification and product certification, focusing on providing medical device enterprises international medical device registration（CE、FDA、CMDCAS、TGA、JPAL、SFDA、PPE）、medical device system certification（ISO13485、YY/T 0287、GMP、QSR820、GSP）,doing second and third party audit for medical device suppliers, providing detail information of c***ulting the medical production manufacturing license.