China medical equipment development

In February 7th, CFDA introduced policies to promote innovative medical devices according to the approval rate, the development of this market ushered in positive energy.

Traditional statistics, the scale of Chinese medical equipment market in 180 billion, compared to the size and drugs, less than 1/5. But from the growth potential, MIC366 that the development of Chinese medical devices will soon enter the era of big leap, better growth prospects than drugs. MIC366 believes that there are facts and trends of the following four aspects to support the above conclusion:

A revision of regulations, promote the development of industry standards

From the CFDA since the formation, the division of the Bureau of senior and medical devices on the market of intensive research can be seen, the government supervisor level have been consciously increase of regulation of medical device industry and promote, also invited Co, entrepreneurs to discuss and open attitude and pragmatic spirit is encouraged.

At the policy level, CFDA recently described as open enough firepower, from devices in the field of "parent Rules Amendment, to production and circulation of standard implementation, adumbrative future Chinese medical device market will show a mergers and acquisitions, integration, standardization, along the development path. At present, the field of medical devices regulatory policy has three main core:

One is to amend the "Regulations" the supervision and administration of medical devices shall be announced to the current fast stage. The new version of the "Regulations" will adjust the product registration and licensing order change from the production site, you must first apply for production licenses after the product registration to register first and then apply for production licenses. This means that the medical device companies can focus on product research and development, market, without pre consumption of resources to invest in production plant, which will greatly ease the pressure of financing of small and medium-sized enterprises, is conducive to innovation.

The second is in the entire industry, the implementation of the medical device production quality management specification (GMP) ": by the end of 2015, all the three types of medical equipment production enterprises must meet the requirements of medical device manufacturing and quality management specification; by the end of 2017, all medical equipment manufacturing enterprises must meet the requirements of the specification.

According to the provisions, the different categories of medical equipment manufacturing enterprises divided into three stages of implementation of norms and use the risk management philosophy stresses the supervision of sterile and implantation of high risk products production enterprises, but also gave the low-risk products production enterprises to gradually improve the transition period. The full implementation of norms, will be conducive to further implement the medical device manufacturing enterprise quality first responsibility, promote the medical equipment industry structure adjustment and industrial upgrading.

Three is the implementation of the "standards for quality control of medical equipment management (GSP)", the supervision relates to the aspect of business processes involved in the procurement, acceptance, storage, transportation, sales, customer service and other services, to ensure full traceability traceability. The specification of the advanced international concepts, requirements and international standards, third types of medical equipment enterprises to establish the computer information management system. On the other hand, is at present the largest number, management is the most chaotic first, second class medical equipment enterprises "spared", in line with national conditions.

Two, efforts to increase support for innovation, achievement of blockbuster products

In February 7th, CFDA issued a "special innovative medical device approval process (Trial)", with the program released, CFDA's Medical Devices Evaluation Center set up innovative medical examination office. The program in accordance with the provisions: early intervention, the person responsible for the approval of the principle of science, the premise is not reduced, in the standard procedure is not reduced, will give priority to handle innovative medical devices.

According to the program, for innovative medical device registration, the Provincial Bureau of 20 working days, CFDA40 working day must respond, that is to say, if there is no problem, the slowest only need to 60 working days can be entered the publicity, publicity period shortest for 10 working days. On the whole, completed from the report to registration could be completed within 15 weeks or so, than in the past have reduced.

In innovation, by the national development and Reform Commission, the Ministry of Finance and Planning Commission jointly proposed the "industrial revitalization and transformation projects, the special support fund for 1 billion 500 million yuan. Are included in the special enterprises is expected to receive generous subsidies red - funds to support more than ten million yuan level. This strength is not great?

Three, accelerate the growth of local enterprises overseas mergers and acquisitions

In 2013, Mindray mergers and acquisitions giant U. S. ultrasound ZONARE, Fosun Pharmaceutical acquisition of medical beauty equipment market, minimally invasive medical acquired American Wright medical orthopaedics business into the Israeli companies Alma. Excellent local enterprises to carry out overseas mergers and acquisitions, internationalization and diversification to signal a strong sense.

As early as since 2010, natong medical group acquired Finnish absorbable materials and products R & D and production enterprises Inion; medical resources, the acquisition of the United States breast MRI equipment company Aurora, Neusoft Group acquired mainly for patients to provide remote medical diagnosis, health care, nursing and other solutions of Israel aerotel Ltd, Lepu medical purchase sales cardiovascular interventional and surgical instruments and Dutch comed company and Jinjiang electronic acquisition of production for the treatment of atrial fibrillation high-end interventional supplies the United States cardima company. Before MINDRAY has completed the acquisition of ZONARE, the United States Datascope life information custody business and Australia distributor Ulco Medical Ltd. two overseas acquisitions.

More and more market mergers and acquisitions, will contribute to the local medical device enterprises to grow, to compare with the foreign counterparts.

Four, intelligent market expansion

In Google glasses, smart wristbands, Samsung best Android smart watches "star effect", smart wear in 2013 overnight, "cold war" era of smart wearable devices really live up.

According to the prediction of research institutions, the next 2-3 years, wearable technology market size from the current $3 billion -50 billion dollars to $30 billion -500 billion dollars, the next 3-5 years the terminal compound growth rate will not be less than 50%. More agency estimates, 2012 Chinese wearable device market reached 610 million yuan, is expected to 2015 Chinese wearable device market size will exceed 10 billion yuan, reached 11 billion 490 million yuan.

Wearable devices, based on the concept of health, at present, no one seems to be divided, the MIC366 that should belong to the home medical equipment, or "smart medical devices" such a new field.

Spoke intelligent, hospital in many medical apparatus and instruments are will be intelligent equipment replaced, even hospital pharmacy, dispensing, logistics will be intelligent equipment (mainly medical robot) gradually replaced, inadvertently expanded a lot of medical equipment market capacity.