This is to announce that,upon investigation,you are suspected of submitting falsified 510K documents signed and issued by the U.S. FDA when applying for the registration of imported medical instrument "nasal cleaner",thus you violate Article 40 of Regulations for the Supervision and Management of Medical Instruments (State Council Order No.276,which entered into force on January 4,2000),Paragraph 3 of Article 19 of Management Measures for the Registration of Medical Instruments (China Food and Drug Administration Order No.16,which entered into force on August 9,2004).According to Article 40 of Regulations for the Supervision and Management of Medical Instruments (State Council Order No.276),this Administration plans to impose the following administrative penalties on you:
1.To revoke the medical instrument registration certificate you have already obtained,that is,certificate G.Sh.Y.J.X.(J.) Zi 2007 No.2541968, and your renewed medical instrument registration certificate G.Sh.Y.J.X.(J.) Zi. 2012 No.2544111;
2.To refuse to accept your application for product registration within two years;
3.To confiscate your illegal gains totaling 1,705,904.30 yuan,and impose a fine of 6,823,617.20 yuan on you,a fine that is four times greater than the amount of your illegal gains.The total amount of the above confiscation and fine shall be 8,529,521.50 yuan (SAY RMB EIGHT THOUSNAD FIVE HUNDRED AND TWENTY-NINE THOUSAND FIVE HUNDRED AND TWENTY-ONE POINT FIVE YUAN ONLY).
Given that these notices can't be served in other ways,this Administration now serves Advance Notice on Administrative Penalty (G.Sh.Y.J.X.F.G. No.1) and Notice on Hearing (G.Sh.Y.J.X.T.G. No.1) to you in accordance with the law.You shall come to this Administration to fetch the above notices within sixty days since the issuance of this Announcement (Contact No.:86-10-88331302/88331368).Failing to do so within the provided time limit will be deemed as the notices have been served.
In accordance with Paragraph 1 of Article 6,Article 31 and Paragraph 1 of Article 42 of the Administrative Punishment Law of the People's Republic of China,you may within three days since the date of service of these notices make a statement or defend yourself,or apply for a hearing at this Administration.Failing to do so before the time limit will be deemed as your waiver of the right to make a statement,defend yourself or apply for a hearing,and this Administration will impose formal administrative penalties on you based on the facts ascertained,grounds and references in the aforesaid notices.
China Food and Drug Administration