FAQs on Health Care and Trade and Commodities
Q1. On February 7, 2014, the China Food and Drug Administration (CFDA) issued a new regulation to formulate a special pathway for review and approval of innovative medical device products that are manufactured in or outside China, and this regulation will become effective from March 1, 2014. What conditions does the special approval pathway require?
A1. The special approval pathway will be available to the extent that the innovative medical device products met all following requirements:
l Key technologies of the product are protected by Chinese invention patents that are lawfully owned by or licensed to the applicant, or the relevant invention patent applications have been published in China;
l The product is “first in China” in terms of its key functions or working mechanism, and exhibits fundamental improvements over current devices with significant clinical value; and
l The early stage research of the product is completed, the research process is true and controlled, and the research data is complete and traceable.
Q2. Who will be the qualified reviewer or decision maker to approve the innovative medical device products?
A2. CFDA will establish a dedicated office and a dedicated expert panel to review and approve the products.
Q3. How long does it cost to review an innovative medical device product?
A3. It will take approximately 60 working days for local products and 40 working days for foreign products.
Q4. Lately, many rich Chinese men are snapping up French chateaux for big bucks, and they are astonished that these French cultural relics are available to private buyers. What does this appearance suggest to the public?
A4. This represents the cultural relics market in China is so closed.
Q5. How is the status for cultural relics in China?
A5. China has a strict licensing and reporting system for cultural relics going abroad. In 2001 and 2013, respectively, China’s State Administration of Cultural Heritage developed regulations that prohibit the work of famous painters and calligraphers who died after 1949 from going abroad. Also, restriction of purchase of cultural relics is regulated. Artifacts are prohibited from going abroad and are banned from being transferred, leased or pledged to foreigners.
Q6. In the past, China has looser control of the cultural relics going abroad. In the 1970s and 1980s, China had an annual outflow of more than a million cultural relics, so to preserve national cultural heritage China’s State Administration of Cultural Heritage tightened its regulations. Is it real that cultural relics are better protected at home and are somehow more likely to be damaged abroad?
A6. It is hard to say which place could provide the best protection for cultural relics. To some degree, it is appropriate to allow some ordinary cultural relics that don’t jeopardize people’s interests to leave the country for the purpose of cultural exchange, and the cultural relics which have important meaning and value to their country of origin should be well kept in their home country.