2017 is about to pass, look back at the past to see the future, 2018 medical device policy level, there will be what a new phenomenon?

1, the medical device market license holder system or to be introduced

At the end of October this year, the "Medical Device Supervision and Administration Regulations Amendment (draft for soliciting opinions)" already mentioned that it is necessary to perfect the system and set the conditions for specifying registrants and filing agents as well as the specific obligations that should be fulfilled. Shanghai has already stipulated In the pilot program, similar laws and regulations have been promulgated in medicine. This policy will allow individuals to have a medical device registration certificate. The old era of "factory ownership and certification" will come to an end and the era of the hegemony of manufacturing enterprises will be over.

2, cancel the medical equipment GMP, GSP certification

With the progress of the revision of "Regulations on the Supervision and Administration of Medical Devices", it will be inevitable to cancel GMP and GSP certification of medical devices. In medicine, many CFDA officials have recently canceled their positions on multiple occasions. The two G certification for medical devices will also be abolished. Instead, they will intensify the supervision afterwards and regulate the procedures, putting greater pressure on enterprises.

3, medical supplies two votes progressively, will not spread in large areas

Currently there are only two provinces with only two supplies of consumables in Shaanxi and Anhui provinces. In addition, nearly 10 cities are promoting two supplies of consumables. From now on, it is unlikely that a large area of provinces (for example, more than half of provinces) will push forward the two-vote system for consumables in 2018, but the gradual opening of a small number of pilot cities for medical reform is a big probability event.

Monitor manufacturer

4, medical device flight inspection sampling more three-dimensional, frequent

With the CFDA medical device inspectors recruitment, training, induction, the number of sampling from the State Administration of flight inspection will be increased, was identified problems in the face of CFDA's "National Announcement" will usher in tremendous pressure on enterprises will be large Affected, provincial and municipal flight tests will also continue, the intensity will not be weakened, thus forming the national, provincial and municipal levels of three-dimensional flying, sampling regular.

5, domestic medical device recall will increase

The signs in recent months have shown that in the past, the phenomenon of recall of only foreign-funded medical devices will come to an end. More and more local medical device companies will also face the issue of recall of their products, either voluntarily or by passive recall, The recall system needs a good traceability system, so the self-built traceability system will also be put on the agenda.

6, medical device product standards will continue to be developed

Many medical equipment products, spreads a wide range of standard issues has been restricting the development of the industry, an important factor in regulating the past two years, the introduction of industry standards intensive, is expected to continue in 2018. As a medical device company, if there is a chance to reference the development of industry standards, it is undoubtedly a relevant and valuable thing.

7, high value supplies set to form 4 + N mode

4 refers to the western coal mining alliance, Beijing-Tianjin-Hebei integration of procurement, four provinces and one city in eastern China joint procurement, procurement consortium Sanming supplies. N refers to the rest of the province's provincial mining. "4 + N mode" will allow the development of entry, did not enter the loss of large markets, accelerate the consolidation of the industry eliminated.

8, high value supplies "national negotiations" varieties will increase

In addition to the three high-value consumables products previously negotiated by the state, 2018 will certainly add new types of negotiations. The abnormal high-margin era will become the past. It is not uncommon for enterprises to pursue rationalized profits. However, a breakthrough in scale may bring More substantial profits.

9, "second bargaining" will spread

Medical large-scale promotion body, "second bargaining" will spread. The state's "Prohibition of Second Bargaining" continues to be trampled on. However, the policy of most provinces is relatively moderate. There will be no over and left policies. Therefore, the "second bargaining" will not be spread in a large area.

10, medical supplies "zero addition" into reality

On November 10 this year, the "Opinions on the Overall Deepening Reform of the Price Mechanism" promulgated by the National Development and Reform Commission proposed to "consolidate the results of canceling the addition of pharmaceutical products and further eliminate the addition of medical consumables." In the abolition of drug addition experience, abolition of supplies will be "light", it is expected that this policy will be able to move forward in 2018.