IP Protection Campaign Launched, Medical Device Classification Catalogue Revised – China Regulatory Brief

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12 national departments jointly launch campaign on IP protection for foreign enterprises

12 national departments, including the State Intellectual Property Office (SIPO), the Ministry of Public Security (SPB), the Ministry of Commerce (MOFCOM), the General Administration of Customs (GAC), the State Administration of Industry and Commerce (SAIC), and the Supreme Court and the Supreme Procuratorate have issued a joint action plan to protect intellectual property (IP) held by foreign businesses.

According to the action plan, the authorities will conduct a special operation from September to December 2017 to crack down on the theft of trade secrets, trademark infringement, patent violations, and online property rights violations.

The operation assigns each department a particular focus. For example, the SAIC is in charge of trademark infringement; the SIPO takes a leading role in patent protection; and the GAC focuses on IP violations in the trading process. Meanwhile, the Supreme Court and Procuratorate facilitate the trial and investigation of IP violation cases.

It is the first time China has started a nationwide campaign to protect foreign businesses’ IP. This campaign is part of the government’s broader effort to attract foreign investment.

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Medical Device Classification Catalogue updated

The China Food and Drug Administration (CFDA) issued the revised version of Medical Device Classification Catalogue on August 31, with effect from August 1, 2018.

The new catalogue, which focuses on the function and clinical application of medical devices, updates the medical device classification significantly. Compared to the previous version, the new catalogue reduces the device categories to 22 from 43, reclassifies the previous 260 devices types into 206 primary types, and further divides the 206 primary types into 1,157 secondary types, which make the classification more scientific and instructive.

Additionally, the new catalogue adds detailed descriptions of the features and intended uses to each secondary type medical devices, with 6,609 examples, to clarify classifications. Moreover, the new catalogue moves 40 devices from Class III to Class I or Class II, and shifts certain type of devices to Class III.

As regulatory control of medical devices in China hinges on classification, the new catalogue will have considerable impact on medical device registration, manufacturing, and distribution. Medical devices companies should check if their devices will be reclassified and develop corresponding plans before the effective date.

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Shanghai FTZ issues license to wholly foreign-owned travel agency

The Shanghai Pilot Free Trade Zone (Shanghai FTZ) has started a pilot program on outbound travel business and issued a business license to Wancheng (Shanghai) Travel Agency Co., Ltd. on September 18, 2017, making it the first wholly foreign-owned travel agency permitted to operate outbound travel business in the zone.

The case reveals that a wholly foreign-owned travel agency must meet three conditions to provide outbound travel service. Firstly, foreign travel agencies can only register in the Shanghai FTZ. Secondly, only investors from Hong Kong or Macau that have held a business license for at least two years can own a foreign travel agency. Thirdly, the travel agency must never be fined for hurting tourists’ legitimate interests, and its domestic travel and inbound travel revenues in the past two years must meet certain conditions.

Qualified travel agencies can apply to the Shanghai Municipal Tourism Administration until December 31, 2019. The pilot program will last for three years, and no more than three travel agencies can obtain the pilot licenses.

The Shanghai FTZ opened outbound travel businesses (excluding Taiwan) to qualified Sino-foreign joint venture travel agencies as early as 2013. The current pilot program is a further liberalization in this sector. Experiences learnt from the pilot program may be extended nationwide in the future.


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