Medical devices new regulation system formed and medical consumables industry to be transformed and upgraded

  • 2017-07-14

The medical consumables in China presented a trend of quantity increase and price fall in 2016, the price war is increasingly intensified.

Recently, the relevant person in charge of the Medical Device Registration Department of China Food and Drug Administration (CFDA) said to the journalist of the 21st Century Business Herald that the new laws and regulations system for medical devices has been formed in China, including over 40 supporting normative documents and over 200 technical review guidelines. It is also known that the medical devices approval in China has been accelerated. In October 2016, CFDA issued the limited approval procedure on medical devices, awarding priority approval to the medical devices for rate disease, malignant cancer, geriatric disease diagnosis or treatment, and the medical devices exclusively and urgently for clinical application of children, and those listed in the national key S&T Special Projects or national key R&D plan.Now, there have been some products listed in the priority approval channel.

In the recent MCC 2017 & the International Cooperation Forum of Medical Industry, Zhou Hui, the chairman of China Chamber for Import and Export of Medicines and Health Products said the medical device industry is in the new state of accelerated transformation and structure optimization, with increasing new materials, new technologies, new techniques and new ideas. Over the past five years, the medical consumables trade in China grows rapidly with increasingly improved product types and quality, the product structure changes from low to middle and high added-value, and manufacturing mode transforms and upgrade from OEM to original design manufacturer, the value of import and export is increasing from USD 7.586 billion in 2012 to USD 8.62 billion in 2016.

However, Meng Dongping, the vice-chairman of China Chamber for Import and Export of Medicines and Health Products said to the journalist of the 21st Century Business Herald that in the international market, the Chinese medical consumables has shared over 60% of the market, but due to the market adjustment for weak international market demand and intensified competition, the Chinese medical consumables presented a trend of quantity increase and price fall in 2016, and the price war between enterprises is increasingly intensified.

As a whole, the Chinese medical consumables market will face an intensifying competition, and the structure upgrading of medical consumables industry is the inevitable trend of development. 

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