The State Council once again shot up, disruptive changes in the medical device industry!

Medical Network May 25th The medical device industry, breakthrough revolution has arrived!

A few days ago, the State Council issued the "Profoundly Deepening the Reform and Opening-up Program for China (Guangdong), (Tianjin), (Fujian) Free Trade Pilot Zones", and made specific plans for the next reform direction of the three regions.

It is worth noting that for the Guangdong and Tianjin Free Trade Zones, the State Council separately proposed:

Enabling applicants for registration of medical devices in Guangdong Pilot Free Trade Zone to entrust Guangdong medical device manufacturers to produce products;

To allow medical device registration applicants in Tianjin Pilot Free Trade Zone to entrust Tianjin medical device manufacturers to produce products.

As a result, the 'separation of licenses', aimed at promoting innovative R&D and professionalization, and the reform of the registrant system for large-scale production of medical devices, have been approved to expand from Shanghai to Guangdong and Tianjin.

The Measures for the Supervision and Administration of the Production of Medical Devices implemented in October 2014 clearly stipulate that only after obtaining a medical device registration certificate can you apply for the production license for Type II and Type III medical devices, and you can only obtain production licenses for production. Medical devices. That is to say, registration and production licenses must be bundled together and must be completed by a single entity.

The reform of the medical device registrant system directly broke through the above policy, allowing companies, institutions and individuals to apply for a medical device registration certificate, and then entrusted other companies to produce corresponding medical devices as a registrant. That is, registration and production licenses may not be one. Subject to complete.

Since last year, with the approval of the State Council, the Shanghai Free Trade Zone has taken the lead in initiating reforms in the reform of the medical device registrant system in the country. This has also triggered a major change in the industry.

The reform of Shanghai has achieved results so far. The joining of Guangdong and Tianjin Free Trade Zones will accelerate the disruptive impact of the medical device registrant system on the industry.

After the reform of the Shanghai medical device registrant system, the first successful crab was Shanghai Minimax. Shanghai Yuanxin Medical Technology Co., Ltd. entrusted Shanghai Minimally Induced Electrophysiology Medical Technology Co., Ltd. to produce a single-channel ECG recorder. The trustees are all subsidiaries of the Shanghai Microcreation Group.

Recently, the Shanghai Municipal Food and Drug Administration published the details of Medtronic’s newly approved surgical power system product registration certificate. The relevant information shows that Medtronic’s product is also a commissioned production model, which bears the Shanghai medical device registrant system. Another fruit of reform.

Unlike Shanghai Microcreation, Medtronic's entrusted manufacturer is Jabil Technology (Shanghai) Co., Ltd. (hereinafter referred to as 'Jeep Shanghai'), which is a professional third-party foundry company. Managed by Medtronic (Shanghai) Limited The company entrusted Jabil General Engineering to produce the Medtronic brand of 'Hubei Injection' as the holder of the registration certificate. medical instruments product.

Global Electronics Foundry enterprise The top three are Foxconn (Hon Hai), Flextronics, and Jabil.

The Jabil Group, headquartered in the United States, is among the world's top 500, with sales of $19.1 billion in fiscal year 2017. Jabil Shanghai, a subsidiary of the Jabil Group, was established in 2002. It is wholly foreign-owned and is currently the Asia Pacific headquarters of the Jabil Group. , One of the major production bases in mainland China, and a medical product production base in Asia.

It is reported that Jabil Shanghai has provided development and design services for electronic circuit board components and systems for global medical device giants such as GE, Philips, Abbott, Poco, Johnson & Johnson, Medtronic (including Kehui).

According to data from the China Medicare Association, Jabil Shanghai has also existed on the top ten list of Chinese medical consumables export enterprises.

As the third largest global foundry giant, Jabil Shanghai has strong production capacity, but its R&D capability is relatively limited. It is difficult to apply for a medical device registration certificate. Previously, it was difficult to apply for a domestic consignment production market because of its policy limitations. Its business is concentrated. For the international market.

Shanghai’s reform allows products to be commissioned at the incubation stage, permitting registrants to entrust more production, allowing trustees that do not have production qualifications to submit registrant medical device registrations to apply for production licenses. The above detailed reform measures will soon lead to trials of medical services. Guangdong and Tianjin, which reformed the device registrant system, are not aware of whether they will follow suit or not. They also need to look at the policies that the two places have adopted further.

However, from the perspective of Shanghai's practice, the reform of the medical device registrant system has brought about changes in the industry.

Shanghai Minimise piloted the internal resources of the larger medical device enterprise group to be integrated and optimized.

The pilots of Medtronic and Jabil Shanghai are more reproducible. It is theoretically feasible to change the trustee to another trustee under the medical device registrant system.

This cooperation model, or as a start, will open up a new path for foreign-owned machinery companies to localize in China.

The far-reaching impact is that with the proliferation of medical device registrant systems, the R&D and production landscape of the industry will all be changed. Professional R&D-type companies and institutions, as well as professional OEM companies will emerge more often. Outsourcing services Become an irreversible industry development trend.

Among these, existing medical device manufacturers will gradually differentiate, some will move closer to the former, some will move closer to the latter, the industrial division of labor will be more rational, and the specialization ability of enterprises will be stronger, but the gap will also be further increased. The strength of the company at the top is getting stronger.

The non-traditional machinery companies such as Jabil, and professional third-party OEM companies, may also penetrate more into China's medical device manufacturing industry, becoming an unshirkable force in the industry.

Global Electronics Foundry Big Three: Foxconn, Flextronics, Jabil.

Flextronics has made breakthroughs in the field of medical device OEM as early as 2010. Flextronics China has medical device product lines in both Suzhou and Guangdong, and its partners include Johnson & Johnson, Abbott, Xerox, Medtronic, Insulet, etc. Instrument, it is said that Flextronics OEM OEM.

Jabil Shanghai breakthrough in the field of medical device OEM is also a few years ago started.

Foxconn has been seeking suppliers of medical equipment products throughout the world in recent years. It has established cooperative relationships with Sotera and Varian.

Compared with only 4%-7% profit margin for OEMs, over 20% profitability for medical equipment OEMs, and faster market growth, the attraction for third-party OEM companies is not small.

The extension and transformation of the field of medical device OEM is a common practice of many professional OEM companies. With the release of the domestic medical device OEM policy, the era of medical device outsourcing will accelerate!