China Food and Drug Administration (CFDA) issued notice exempting 140 Class II medical devices from submitting clinical trial when device producers apply for market entry from CFDA. This is already the second batch of clinical trial exemption.
For a Class II device maker outside China, perhaps JV with a local Chinese producer is one the best options if one looks for a long term reward in the Chinese market, depending on the nature of the product itself.
26 February, 2014
11 February, 2014
New Opportunities in Chinese Health Care Market
On 28 September 2013, the State Council of China issued ‘Several Opinions of the State Council on Speeding up the Development of Healthcare Services’, which was soon brought under the spotlight of the industry.
This document expressed a reform plan which will be guided by the authorities but driven by the market, focusing not only on medical care sector, but also health care sector.
The target of the development of Chinese healthcare services will result in a market size of 8.000 billion RMB with below major targets:
1. Drastic improvement in capability of medical care. This will rely on a balanced system in which the stake holders are non-profit & profit hospitals, public and non-public hospitals, medical treatment, rehabilitation and caring services.
2. Significant improvement in levels of health care management and standards of services. Traditional Chinese health care, caring of aged people, healthcare consultation, sports medical and health care touring services will be encouraged.
3. Improvement in health insurance mechanism. Commercial healthcare insurance should play a more important role in the entire healthcare insurance mechanism.
4. Expansion of supporting clusters of healthcare services. This refers to third party lab centers, third party imaging centers, R & D and manufacturing of (new) drugs, (new) medical and in-vitro devices, rehabilitation devices, healthcare products and fitness equipment.
To achieve the ambitious targets, the government will allow different forms of capitals to enter the market, treat facilities run by private capitals equally to public owned entities. 50%-100% of administrative fees will also be waived by the authorities.
This top-down reform offers tremendous opportunities to huge number of enterprises in the medical & health care industry, especially those prepared early birds.
This document expressed a reform plan which will be guided by the authorities but driven by the market, focusing not only on medical care sector, but also health care sector.
The target of the development of Chinese healthcare services will result in a market size of 8.000 billion RMB with below major targets:
1. Drastic improvement in capability of medical care. This will rely on a balanced system in which the stake holders are non-profit & profit hospitals, public and non-public hospitals, medical treatment, rehabilitation and caring services.
2. Significant improvement in levels of health care management and standards of services. Traditional Chinese health care, caring of aged people, healthcare consultation, sports medical and health care touring services will be encouraged.
3. Improvement in health insurance mechanism. Commercial healthcare insurance should play a more important role in the entire healthcare insurance mechanism.
4. Expansion of supporting clusters of healthcare services. This refers to third party lab centers, third party imaging centers, R & D and manufacturing of (new) drugs, (new) medical and in-vitro devices, rehabilitation devices, healthcare products and fitness equipment.
To achieve the ambitious targets, the government will allow different forms of capitals to enter the market, treat facilities run by private capitals equally to public owned entities. 50%-100% of administrative fees will also be waived by the authorities.
This top-down reform offers tremendous opportunities to huge number of enterprises in the medical & health care industry, especially those prepared early birds.
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