07/08/2018 CFDA released notice on registered information management for medical device production and operation license

On 2nd August CFDA released notice on registered information management for medical device production and operation license. The notice required the provincial level CFDA to facilitate catalogue adjustment, information disclosure and uploading.

  • From 1st of August, the new operation license should be categorized in accordance both original and new catalogue;
  • The provincial level CFDA should disclose openly production and operation license registed information online timely
  • The provincial level CFDA should assign special personnel in charge of data uploading for national level interconnection

http://cnda.cfda.gov.cn/WS04/CL2197/329783.html

07/08/2018 CFDA released “management of imported medical devices agent (draft)” and called for public comment

On 2nd August, CFDA released management of imported medical devices agent (draft) for public comment. The draft defined clearly the requirements for agent and also their obligation. The provincial level CFDA should timely gather agent situation, develop agent catalogue and conduct inspection on site and on annual self-examination report.

http://cnda.cfda.gov.cn/WS04/CL2051/329805.html

02/07/2018 Ministry of Justice called for public comments on the amended regulation on supervision and management of medical devices (draft)

On 25th June, the ministry of justice published the amended regulation on supervision and management of medical devices (draft) and called for public comments. Deadline was 24th July 2018. The main amended contents were listed as follow:

            Consummate the marketing authorization holder of medical devices

            Reform the management of clinical trials

            Consummate the approval process

            Consummate the market surveillance

http://www.moj.gov.cn/government_public/content/2018-06/25/tzwj_21121.html

11/9/2017 Seminar on Re- Manufacturing of Medical Imaging Equipment in Beijing

Sponsored by the COCIR, the seminar was held to facilitate communication between Chinese and Foreign medical device stakeholders in Tsinghua University on September 8, 2017. Representatives of MIIT, MEP, Remanufacturing Technology National Key Laboratory, EU delegation, SESEC, FDA China office, Basel convention Asia-pacific center, China Association for Medical Devices Industry, as well as China’s medical equipment enterprises attended the meeting. The guests respectively made presentations on the Basel convention, The Development of Chinese re-manufacturing standards and industry, COCIR vision and experience on circular economy/material efficiency, US FDA regulatory requirements on remanufacturing, etc.
At present, China’s remanufacturing focuses mainly on automobiles, engineering machinery, machine tools and other industries, and the regulations and standards in the field of remanufacturing are still to be further developed. In the field of medical devices, remanufacturing regulations have yet to be further opened, and standards remain to be developed. The experience of Europe and US in this field will be a useful reference for China’s industrial construction. The meeting provided a good platform for both parties to have a better understanding of each other, and will also promote the development of China’s remanufacturing industry.

Guiding Opinions Issued to Promote Healthy Development of Pharmaceutical Industry

The General Office of the State Council issued the “Guiding Opinions on Promoting the Healthy Development of the Pharmaceutical Industry” which aims to promote the sustainable and healthy development of the pharmaceutical industry in China.

The Opinions specify seven key tasks to achieve this goal. The first is to strengthen technological innovation and enhance the core competitiveness. The second is to speed up quality upgrade and promote green and safe development. The third is to optimize the industrial structure and improve intensive development. The fourth is to develop modern logistics and build a pharmaceutical credit system. The fifth is to keep close pace with health care reforms and create a favorable market environment. The sixth is to deepen international cooperation and expand the space for international development. The seventh is to nurture emerging business forms and promote intellectual industrial development.

The Opinions require that it is imperative to strengthen fiscal and financial support, perfect the government procurement mechanism, deepen the reform of evaluation and approval, strengthen coordinated industrial supervision, support the promotion of innovative products, and accelerate the building of talent teams. The National Development and Reform Commission shall strengthen planning and co-ordination, clarify the specific schedule for the implementation of various policy measures and, in concert with the relevant departments, strengthen policy guidance and supervision and inspection, so as to promote sustainable and healthy development of the pharmaceutical industry.

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