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INTERPRETMedical equipment law
Government attaches importance to the third party medical repair service provider and obtains the policy support of State Council
Source:TopMed 2016-10-31

On March 11, 2016, the General Office of State Council printed and issued Guiding Opinions on Promoting Healthy Development of Medical Industry GBF [2016] No.11.

In which, in the Opinions of the State Council, the policy contents explicitly express that the State Council encourages and support the development of the third party medical repair service provider!!

Medical Device Quality Supervision and Administration Measures that has been implemented since this February proposes that, repair service institution with condition and capacity can be entrusted to have medical device maintenance and repair. The insiders believe that with the vigorous development of medical equipment, coupled with the national policy guide, after-sale third party agent will face broad market space.

In October 2015, the government explicitly regulated that the medical device user can entrust repair service institution with condition and capacity to have medical device repair and maintenance, let’s review relevant content of Medical Device Quality Supervision and Administration Measures No.18 order.

Time of socialized outsourcing service, awake the rise of new life

With the industrial development in the future, domestic medical equipment third party service provider is expanding and developing, gradually from “small shop” with “one-way attack“ to “scale effect”, many medical equipment third party service pioneers seek for better development blueprint. 

First, hospital has an obvious “20-80 law”: the equipment quantity covered in the warranty contract signed by hospital and manufacturer is only 20% large and new machine, the rest 80% equipment is basically let go, lack of system maintenance, repair and test. This point may become a hidden boom in the finance of hospital, when the machine without warranty contract is repaired, there will be many temporary expenses and completely cause uncontrolled finance of hospital. If a third party service provider can provide overall packed service to the maintenance of large medical device of hospital, it will yield twice the result with half the effort.

How to choose qualified equipment management service supplier?

At present, there are many medium and small repair companies in China, however, the company that can provide socialized overall medical equipment outsourcing service is rare, the requirement on providing such service is very high, and high-quality service provider shall meet the following requirement:

  • With relevant management equipment experience, with certain company scale

  • With improved repair part warehouse

  • Supported by information management platform

  • With complete service process system and supervision system

  • Can provide equipment management analysis data required by the hospital

Shanghai TOPMED Information Technology Co., Ltd. completely meets aforesaid requirements. We hear the voice of the government, meet the hospital requirement, through our information technology management measure, establish high-quality team, test service center and customized service according to the government laws and regulations, provide high-quality all-round management service to hospital equipment, control cost and improve working efficiency.

The General Office of State Council printed and issued Guiding Opinions on Promoting Healthy Development of Medical Industry GBF [2016] No.11, which proposes the following guidance on the health development of medical industry besides supporting and encouraging the third party repair service provider.

Analyse opinions

Main objective

In 2020

1. The innovation capacity of medical industry is obviously improved, the supply guarantee capacity is obviously strengthened, more than 90% significant patent expired drugs realize imitation listing, the situation of short supply of clinical drug is effectively relaxed

2. Green industrial development, safe and efficient, quality management level is obviously improved.

3. Industrial organization structure is further optimized, system mechanism is gradually improved, market environment is obviously improved.

4. Scale of medical industry is further increased, annual average growth of main business income is higher than 10%, the growth of industrial added value keeps leading in the industry.

 

Main task

Strengthen technical innovation, improve core competitiveness.

  • Promote improvement of innovation capacity. Accelerate transformation and upgrading of medical device.

  • Promote industrialization of significant drug. Promote modernization of traditional Chinese medicine.

Accelerate quality upgrading, promote green and safe development.

  • Strictly manage product quality. Improve quality standard system.

  • Improve quality control technology. Implement green reform upgrading.

Optimize industrial structure, improve intensive development level.

  • Adjust industrial organization structure. Guide industrial cluster development

  • Promote regional coordinated development.

Develop modern logistics, construct medical credit system.

  • Establish modern marketing mode.

  • Strengthen credit system construction.

Closely connect with medical reform, create good market environment.

  • Improve medical service system.

  • Improve price, medical insurance policy.

Deepen external cooperation, broaden international development space.

  • Optimize product export structure. Accelerate international cooperation.

  • Promote international registration certification.

Cultivate emerging business mode, promote intelligent industrial development.

  • Construct intelligent demonstration factory.

  • Provide intelligent medical service.

Strengthen policy guarantee and organization implementation

  • Strengthen financial support

  • Support promotion of innovative product

  • Improve government purchase mechanism

  • Deepen review and approval reform

  • Accelerate construction of talent team

  • Strengthen industrial collaborative supervision