Shanghai Free Trade Zone | 'license separation' | with an upgraded version | Medical Device Registration Certificate trial

Pharmaceutical Network December 15 hearing December 7, the Shanghai Food and Drug Administration released a program in the China Free Trade Zone pilot first try 'medical device registrant system' This pilot changed the registration of medical device products and Production license "bundled" model, eligible applicants can apply for a separate medical device registration card, and then entrusted to the production of qualified and productive enterprises.

This is a new measure taken in the 2.0 version of the "Free Trade Zone License" reform in Shanghai Free Trade Zone. From version 1.0 to version 2.0, the Shanghai Free Trade Zone took less than two years.

The 19th Plenum of the Party proposed: "Give greater freedom to reform the Pilot Free Trade Zone and explore the building of a free trade port." A better emancipation and decentralization, The reform of the new area as an important focus of efforts.

Deepening the implementation of the 'separation of licenses and permits' is exactly what Pudong conducted in an audacious and self-reliant manner and provided an important entry point for the whole country to replicate and popularize its experience.

Wang Xiaoyan did not expect to actually meet with a reform of the Shanghai Free Trade Zone by accident.He is a sales director of a foreign-funded hotel in Beijing, before finding that domestic high-quality training for their own almost 'blank', a training business of PricewaterhouseCoopers , Let her suddenly heartbeat.

PricewaterhouseCoopers business skills training company is China's first wholly foreign-owned vocational training institutions, this 'zero breakthrough', thanks to the Shanghai FTZ 'separation of licenses' reform.

According to the original procedure, enterprises should apply for a business license in advance to the business sector, and the business sector should consult with the people's government department whether they agree with the relevant permission or not, but the social service department has no right The preparation of enterprises can not determine whether the licensing issue, the enterprise bid to plunge into an endless loop.

On the New Year's Day in 2016, with the approval of the State Council, the Shanghai FTZ took the lead in launching pilot reform of 'license separation separation' in the whole country and promulgated 116 approval items in accordance with the cancellation, alteration of the record and promises to enhance transparency and predictability and to strengthen access control The reform of the way.Pwc has applied for a business license and preparation for the permit.After three months, the training company officially opened, Wang Xiaoyan become one of the first batch of 30 students.

Liquid foundation, lipstick and other imported non-special purpose cosmetic Into our market, the past need national food drug Regulatory approval of the 'access', and now only to the Shanghai Food and Drug Administration to submit the record information, 3 days to obtain the record that this means that the world's most popular non-special cosmetics can be simultaneously listed in China.

'Separation of licenses' reform, let enterprise According to a survey conducted by a third-party assessment agency, 87% of the enterprises believed that the post-reform accreditation is highly facilitated, and the "license separation" has now been copied and extended to 10 cities such as Tianjin, Liaoning, Zhejiang and Fujian Trade area.

'Next, the market competition mechanism can be effectively adjusted, companies can manage their own affairs and by strengthening the matter after the regulatory supervision and management can achieve the purpose of examination and approval items, will gradually be canceled.' Pudong New Area, deputy director of the Organization Department, deputy director Jin Sha said that the government departments sorted out 548 market access approval items from enterprises at the national, municipal and district levels and fully incorporated them into the scope of the reform.

How to keep up with the follow-up regulation? Shanghai Free Trade Area Exploring the "Six-Double" (Double Awareness, Double Feedback, Double Tracking) Licensing Mechanism and Double Random, Double Evaluation and Dual Publicity Regulatory Collaboration Mechanism) as the core of the government comprehensive supervision mechanism in the Pudong New Area to achieve industry-wide coverage, things in the aftermath comprehensive regulatory platform to achieve full chain through the market main body to achieve full life-cycle tracking.

In the Pudong New Area Health and Family Planning Commission Supervision, Medical Practice Supervision Section Chief Zhou Hongdong online opened a full life cycle of oral clinics. Outpatient clinics set up at the end of March, twice for undocumented business be punished. 'Market Authority issued a business license, will be 'double notice.' 'Zhou Hongdong explained that is not only informed the business how to handle the permit, so that enterprises are committed to not engage in unauthorized permits before the relevant business activities, and the business registration Information pushed to the relevant administrative licensing authorities, to remind the relevant departments in a timely manner, follow-up supervision.

'If an enterprise is found to be unable to fulfill its promise, it will be put on the list of untrustworthy ones, with one place of dishonesty and the other all being limited.' Zhao Guobao, deputy director of the Shanghai Foreign Economic Relations and Trade Administration Commission of the State Administration of Foreign Trade and Economic Cooperation, said that the regulatory authorities will send the enterprise information Pushed to the unified department of the whole region 'six dual' comprehensive government regulatory platform, in the financial support, the government purchase Such as early warning tips and joint disciplinary work.

'At present, Pudong New Area, involving 108 industries, more than 200 market authorities for the approval and inspection of 21 regulatory authorities, all set up a' six pairs of 'regulatory mechanism.' Zhao told reporters that they recently 21 A department of 'six double' work carried out acceptance, all departments have reached more than 80 points.

In the Pudong New Area online government hall to find 'business map' search for 'wine' word, found the 'alcohol retail license', click on 'do it now', fill in the form, upload materials, a few minutes to get 3 days later, Obtain a permit directly in the service window, 'almost unbelievable!' Chen Ting, general manager of Haibo Wen Food Co., Ltd. is very surprised.

'If you choose to express, do not even have to meet.' Pudong New Area, Organization Department of the administrative examination and approval system reform director Xiao Lin laughed.

The "Map of Opening a Business" launched on trial in November was a new measure for deepening the pilot reform of "separation of licenses and licenses" in Shanghai's FTA. "We broke the sector setting and classified the national economic sector as an index to establish a pilot scheme that covers the national, Level 548 enterprise market access approval matters online query platform for businesses to provide one-stop service. 'Xiao Lin said the next step, Pudong will timely registration, pre-permit,' multiple card one 'and other companies Inclusion of the type of matters into the 'map'.

In Shanghai, the simplification and decentralization of delegates represented by the separation of licenses and licenses has become the core measure for speeding up the transformation of government functions.

November 17, Shanghai Free Trade Zone Administrative Service Center window on the 19th, more than a 'please find fault' advice channel. Online government hall also opened the same section in the home page. Online and offline interaction, please the masses together Judicial government services' flow is not smooth, high efficiency is not high, good service, complicated procedures. "

Some enterprises put forward 'processing food permit waiting time is too long', after analysis found that the number of people who take the site in front of more online booking number, so the center quickly adjust the window settings, set the scene for the first priority window, site number waiting time From about 2 hours to 20 minutes. 'Government to provide services, more and more market needs, citizen needs as a starting point.' Pudong New Area Government Office Deputy Director, Jiang Hongjun, director of the Administrative Services Center said.

At present, Pudong New Area is targeting at enterprises, individuals and different government entities to create a "market-wide network for business access" and "community-wide communication of personal community affairs" and "global sharing of government and government affairs information" The 'three full project'.