English
1.Measures on Supervision and Administration of Online Sale of Medical Devices (the “Measures”) has been issued on 20th December 2017 and will become effective on 1st March 2018, which will apply to the enterprises engaged in online sale of medical devices (“Online Medical Device Sellers”) and the third party platform providers for online sale of medical devices (“Online Sale Platform Providers”). The Measures provide that:
(1) Online Medical Device Sellers should
complete recordal of the relevant information (e.g. the basic information of the enterprise, website and registration and recordal status of medical devices) with the Food and Drug Administration at a municipal level.
obtain Internet Medicine Information Service Qualification Certificate for its own website, if any.
post the medical device manufacturing and operation certificate/recordal certificate and the medical device registration certificate /recordal certificate in the website as required.
maintain the sales record for at least 2 years after the expiration date of the medical devices, at least 5 years in the absence of the expiration date and permanently for implanted medical devices.
(2) Online Sale Platform Providers should
obtain Internet Medicine Information Service Qualification Certificate.
complete recordal with the Food and Drug Administration at a provincial level.
provide the serial number of the recordal certificate of third party platform for online sale of medical devices in its homepage.
verify the information of the enterprises selling medical devices via the platform, supervise their sale activities and maintain the sales record as mentioned above.
Therefore, it is advisable that the enterprises that have been or will be engaged in online sale of medical device and the relevant online sale platform providers should complete the relevant registration/recordal according to the Measures and set up the internet online sales guidelines as soon as practicable so that online sale of medical devices can be carried out after 1st March 2018.
2.Decision of the State Council on Temporary Adjustment of the Relevant Administrative Regulations, State Council Documents and Departmental Rules Approved by the State Council in the Pilot Free Trade Zones (the “Decision”) was issued on 9th January 2018, which further lowers the threshold for foreign investment in the pilot free trade zones. The industries/areas for foreign investment covered by the Decision include:
(1)Registration of Ship
(2)Printing
(3)Civil Aviation
(4)Certification and Accreditation
(5)Entertainment
(6)Sino-foreign Cooperative Education
(7)Travel Agency
(8)Direct Sale
(9)Gas Station
(10)International Shipping
(11)Purchase and Wholesale of Rice, Wheat and Corn
(12)Design, Production and Repair of Aircraft
(13)Urban Rail Transit
(14)Business Premises for Internet-access Services
(15)Foreign Invested Bank
(16)Commercial Performance
Items from (1) to (9) above have been adopted in the pilot free trade zones in Shanghai, Guangdong, Tianjin and Fujian, which now also apply to all other pilot free trade zones in China. Items from (10) to (16) are now applicable to all the pilot free trade zones in China.
Therefore, the foreign investors who expect to invest in the above areas may consider the pilot free trade zones as the first location for such investment.
3.Notice of Shanghai Supreme Court on Filing of Cases (II) (the “Notice”) was issued and enforced on 23rd November 2017, which provides the guidelines for determination of the domicile of legal entities.
For determination of the domicile of a legal entity, there were different standards in the past judicial practice, e.g. the standards of principal business place, management place and registered address. The Notice expressly provides that the domicile of a legal entity should be the registered address of the legal entity.
Thus, according to the Notice, where the court of the domicile of a legal entity is the competent court, the court should be the court of the registered address of the legal entity. Therefore, if a company enters into a contract with another company which provides that any dispute shall be brought to the court of the domicile of a party or the domicile of plaintiff/defendant, it is advisable to confirm in advance as to whether the registered address of the counterparty is consistent with its business place, as in practice, many companies are registered in some remote Economic Development Zone which however are conducting business in downtown commercial centers. If the company does not expect to submit any dispute to the court of the registered address of the counterparty, the parties may reach an agreement on the competent court under the contract.
Please note that, as the Notice was issued by Shanghai Supreme Court, the Notice applies to the cases over which Shanghai has jurisdiction.
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