Green Path for Innovative Medical Devices’ Registration in China Umy Wu On November 2, 2018, National Medical Products Administration (“NMPA”) announced Procedures for the Special Eva

Green Path for Innovative Medical Devices’ Registration in China

                                                                                    UmyWu

OnNovember 2, 2018, National Medical Products Administration (“NMPA”) announced Procedures for the Special Evaluation ofInnovative Medical Devices (the “NewProcedure”) which will take into effect on December 1, 2018. Actually, asfar back as 2014, CFDA (NMPA predecessor) formulated the Procedures for the Special Evaluation of Innovative Medical Devices(for Trial Implementation) (the “2014Procedure”) which opened a fast and green path for innovative medicaldevices’ registration. After 4 years’ implementation, more than 165 medicaldevices were reviewed under such special procedure and 30 medical devices havebeen approved in accordance with 2014 Procedure. Based on the successfulpractice, New Procedure is formulated consistent with the principle provisionsof 2014 Procedure, but more detailed to further promote and optimize the scopeand approval procedures of innovative medical device registrations.

A.Scopeof Application

TheNew Procedure is applicable only to qualified Class II or Class III medicaldevices. In this context, Class I medical devicesshall be still filed and registered under Regulationson Supervision and Administration of Medical Devices.

B.QualifiedApplication

Theapplication must meet the following three criteria: (a) applicant either holdsa valid invention patent of core technologies itself or by assignment or itspatent application has been publicly announced and supported by a search reportissued by the Patent Retrieval and Consulting Center of the State IntellectualProperty Bureau indicating the novelty and creativeness of such core technology;(b) applicant has completed preliminary research and fixed product prototype,in addition, the research process is real and controlled and the research datais complete and traceable; and (c) the products is first in its kind in Chinain terms of its mechanism and functions and is technically-advancedinternationally and has significant clinical practical value.

C.ProceduralHighlights

(a)Priority in Review

NewProcedure requires that drug regulatory departments and institutions at alllevels shall handle applications for innovative medical devices on a prioritybasis, including the inspections, technical reviews, and administrativeapprovals. Additionally, NMPA shall give priority to the examination and reviewof the change application for innovative medical device where such innovativemedical device has been approved in accordance with New Procedure.

(b)Examination and Review Period

Pursuantto New Procedure, the provincial drug administration shall complete the preliminaryreview and give its opinion within 20 working days. Further, the applicationwill be referred to NMPA’s Review Office and then NMPA’s Review Office shallorganize expert to review the application and provide an opinion within 60working days after the acceptance of such application. After being reviewed bythe NMPA’s Review Office, the applicant and product which is to undergo specialexamination and approval shall be publicized on the official website for atleast 10 working days. If no objection is raised to the applicant and productduring the publicity period, the NMPA’s Review Office shall make final decisionand publish such decision on its official website. In other words, a qualifiedinnovative medical device may be registered within 3 months under the NewProcedure which is significantly shorter than the period under Regulations on Supervision andAdministration of Medical Devices.

(c)Opportunity for Consultation

NewProcedure also enhances the communication and exchange channels between the NMPAand applicants. In addition to communicate with NMPA through filling in thecommunication and exchange application form for innovative medical device, theNational Bureau of Machinery Examination Center, a branch of NMPA, hasconducted pilot projects in some provinces to hold expert review meetingsthrough remote video in which applicant can participate and communicate withexperts discussing any issues arising from or in connection with the innovativemedical devices review.

D.ForeignApplicant

NewProcedure explicitly stipulates that New Procedure is also applicable to foreignapplicants. However, foreign applicant could not submit application itself but needto entrust a Chinese corporate agent or its subsidiary in China to file suchapplication. Following documents shall be submitted: (a) letter of attorney authorizingthe Chinese agent or applicant’s Chinese office to apply for specialexamination of innovative medical devices; (b) letter of undertaking of the Chineseagent or the applicant's Chinese office; (c) the business license of the Chineseagent or the certificate of the applicant’s Chinese office. If the originals ofthe above documents are made in foreign language, a Chinese translation shallbe submitted together with the originals.

[UmyWu: an associate with Grandway Law Offices, LL.M. from Washington University inSt. Louis School of Law]