The CFDA requires that all Pharmaceutical companies which located out of China must appoint a registered Legal Agent (LA, in-country regulatory representative). Appointed CFDA LA must be a legal entity and maintain a place of business in China. RJS MedTech. Inc. is eligible to be your LA in China with the help of our office in Beijing, Shanghai & Guangdong.
We are engaged in the fields of pharma, medical device, health food,cosmetics products CFDA & MOH registration business almost 10 years, help the dozens of manufacturers, hundreds of products to enter Chinese market. we know how to guide the manufacturer on preparation of CFDA Application Dossier, and avoidance of failures and defects in registration procedure, Help foreign manufacturer obtained IDL (Import Drug Licence) successfully!
Though the requirements for review of drug registration in China are more and more in accordance with ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), there are still lots of differences and special local requirements. You might waste much more time on supplement or recomposition of Application Dossier if you do not understand the special requirements of drug registration in China. Therefore, an experienced consulting agency is able to assist you to prepare the Application Dossier according to the requirements, and handle the registration procedure smoothly.
Our consulting services including:
1. Evaluating whether your products can be registered in China without policy obstacles or illegal situations.
2. Assessing how many fees and how long the procedure takes.
3. Guiding how to prepare the data and information on Application Dossier.
4. Reviewing the data and information provided by manufacturer/company, then estimating whether they meet the requirements of China or not.
5. Translating, compiling the Application Dossier in Chinese.
6. Tracking and handling the registration procedure, then ensuring manufacturer/company could obtain IDL or CTP in time.
7. Organizing and monitoring the clinical trials.
8. Technical support.