China is the world's second largest market for medical products, second only to the US. For innovative pharmaceutical and medical device companies, the vast user base in the China market provides huge revenue potential for their products.

However, in conventional pathways novel drugs and medical devices need to go through strict clinical trials to get approval by the National Medical Products Administration (NMPA), before entering the market legally for sale, which takes many years.

The good news is that if your medical product has been approved for market by regulatory agencies in other countries, it can be legally sold in China through a fast track without waiting for the lengthy clinical trials and approval process in the conventional pathways.

These regulatory agencies include:

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• The Food and Drug Administration (FDA) in the US, 

• The Medicine and Healthcare Products Regulatory Agency (MHRA) in UK, 

• The Therapeutic Goods Administration (TGA) in Australia, 

• The Central Drug Standard Control Organization (CDSCO) in India, 

• The European Medicine Agency, EMEA, in Europe, 

• The Danish Medicine Agency in Denmark, 

• The Medsafe Medicine and Medical Devices Safety Authority in New Zealand, 

• The Medical Product Agency (MPA) in Sweden, 

• The Medicine Evaluation Board in the Netherlands, 

• The Irish Medicine Board in Ireland, 

• The Italian Pharmaceutical Agency in Italy, 

• The Swiss Agency for Therapeutic Products in Switzerland, 

• The Ministry of Health, Labour&Welfare (MHLW) in Japan.

In 2024 the healthcare industries worldwide are facing enormous challenges. China's opportunities may help you rise amidst these challenges!

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For detailed information about the fast track for novel drugs and medical devices to enter the China market, please feel free to contact us at: BD@bio.cacnex.com