Pharmaceutical Network December 4 News 2017 is about to pass, looking back to see the future, 2018 medical device policy level, what will be a new phenomenon? The author analyzes the following, please Paizhuan.
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, at drug Aspect, similar Regulations It has been introduced. This policy will allow individuals to own medical instruments Certificate of registration, 'the factory has a certificate of the old era to be over, production enterprise Hegemony era to 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 is inevitable to cancel the GMP and GSP certification of medical devices.In the aspect of pharmaceuticals, many CFDA officials have canceled their positions on many occasions recently, and the two G certification of medical devices Will be canceled, replaced by the strengthening of ex post regulation, the process of norms, in terms of enterprises more pressure.
3, medical supplies two votes progressively, will not spread in large areas
There are currently only two provinces with only two supplies of consumables in Shaanxi and Anhui provinces, and in addition, nearly 10 cities are promoting two supplies of consumables. For now, a large area (for example, more than half of provinces) Supplies two votes is unlikely, but a small number of pilot cities to open medical reform is a big probability event.
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 'National Bulletin' 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
The large number of 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 business, if you have the opportunity to refer to the industry standard The formulation is undoubtedly a relevant and valuable thing.
7, high value supplies set to form 4 + N mode
4 refers to the Western Mining Alliance, Beijing-Tianjin-Hebei integration of procurement, four provinces and one city in eastern China joint procurement, Sanming consumables procurement alliance. N refers to the remaining provinces provincial mining. '4 + N model' will allow access to get Development, 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 bargain' will spread
Large-scale medical and medical promotion, 'second bargaining' will also spread the country's "no bargaining twice," the provisions continue to be trampled, but most provinces are more moderate policies, there will be no excesses, left the policy, so 'two Bargaining 'will not be able to spread a large area.
10, medical supplies 'zero addition' into reality
On November 10 this year, the "Opinions on Reforming the Price Mechanism in an All-round Way" promulgated by the National Development and Reform Commission proposed that we should 'consolidate the results of eliminating drug additions and further cancel the addition of medical consumables'. "On the experience of canceling drug additions, As a result, it is expected that this policy will be pushed forward in 2018.
11, 'Medicare and control fees' is still the main theme
Combined with Medicare 'pay according to disease' and other comprehensive reform ideas, as a result of medical insurance control costs is to promote hospital Minimize the use of supplies, thus affecting the overall use of supplies.
12, multi-part continue to support domestic medical equipment
The domestic medical device support policies given by many ministries from different perspectives will surely continue. More and more domestic innovative products will enter the market and impact imports. However, it is unrealistic to completely shake up the position of foreign capital in the high-end fields. The rise of domestic products Still take a long time.
