Shanghai’s 100 opening-up measures unveiled on the 10th of July sent a jolt of excitement to both foreign and domestic industry leaders. Shanghai, well-known the financial center of China, is aiming to improve its service and manufacturing industries. With its ambition to be an import hub serving the whole country and the objective to create a convenient international business environment, Shanghai will deepen the construction of the pilot Free Trade Zone (FTZ) to attract foreign investment and reform innovation-driven development.
7 of 100 specific measures will have a direct impact on the Medical device industry:
• No.69: Develop the agglomeration function of the medical device trading platform and improve professional services. In addition, this measure will create a distribution center for import goods which extends to the Yangtze River Delta and serves the whole country.
• No. 80: Simplify import procedures for samples, equipment, reagents, and other foreign-owned R&D essentials. The customs clearance duration will be shortened to 15 days for the import of medical device research & development tools used by qualified biomedical service outsourcing companies.
• No.86: Expanded use in Shanghai for medical devices that treat life-threatening diseases but require a clinical trial to be approved for registration in China.
• No.87: Extend the MAH (Medical Device Marketing Authorization Holder) reform pilot area to the whole city, and gradually to the Yangtze River Delta region.
• No. 88: Cancel the Group B large-scale medical equipment setup approval scheme and replace it with a pilot notification system.
• No.89: Promote the construction of national level key laboratories for medical device inspection and testing, to achieve international accreditation.
• No.90: Support promotion of flexible entry management such as “One entry, batch clearance”, improve the efficiency of device clearance and establish an international supply chain platform which integrates domestic and international trade.
These measures will have a huge impact on investment, innovation, trading, supply chain management, customs clearance and sales of medical devices. Measure 86 will make the clinical trials of innovative medical devices much easier. Questions remain as to how “expanded use” will work in practice but, it will undoubtedly speed up and save the cost of registration. The MAH system, mentioned in measure 87, will be expanded to the whole city by the end of June (2018). Authorization holders will be free to subcontract production to qualified OEMs which will make the industry operation more efficient and cost-effective for innovative medical device companies.
As one of the actions, and following China's Belt and Road Initiative, Shanghai will host the “China International Import Expo” in early November to build an import promotion network that covers the whole world. It will be a great opportunity for advancing medical device technologies.
Qserve established an entity in China in January of 2014 and is now a recognized member of MDTA (Shanghai Pudong Medical Device Trade Association). We continuously monitor the implementation of new policies and keep our clients informed. Please do not hesitate to contact us if you’re interested to know more.
Shanghai Pudong Medical Device Trade Association (MDTA), located in the Shanghai Free Trade Zone, is voluntarily formed and composed of leading multi-national medical device corporations including; Siemens, GE, Johnson & Johnson, 3M, BD, Fresenius, Zimmer, Boston Scientific, Synthes, Terumo, Abbott, Olympus and more. MDTA aims to bridge the communication gap between government and enterprises, to strengthen the self-discipline, compliance, and promote advances in medicine.
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