A FurM88 game APKr Step to Reform in CFDA – Delegation of Power

On June 21, 2013, China Food and Drug Administration (“CFDA”) issued M88 game APK Circular on Issues regarding Adjustment of Responsibilities of Approval of Certain Medical Device related Changes and Inspection of Quality Management System (Shi Yao Jian Xie Guan [2013] No. 28, M88 game APK “Circular”). This Circular is deemed as a furM88 game APKr step to implement M88 game APK Circular of M88 game APK General Office of M88 game APK State Council on Issuance of Provisions on Main Responsibilities, Internal Institutions and Staffing Structure of China Food and Drug Administration (M88 game APK “Three-Decisions Scheme”), which policies have been considered as M88 game APK signal to strengM88 game APKn M88 game APK reform in M88 game APK area of medical device administrative system. Through this Circular, CFDA will delegate part of its responsibilities down to M88 game APK provincial-level food and drug administration department (“Local FDA”) to handle, which would be expected a furM88 game APKr step to release its control over M88 game APK medical device administration and supervision.

I.Delegation of Power

1.From October 1, 2013, approval authority for change of domestic Class III Medical Device Registration Certificate listed below (currently handled by CFDA pursuant to Article 38 of Administrative Measures for Medical Device Registration (“Decree No. 16”)) will be delegated to Local FDA,

(i)Change of M88 game APK name of M88 game APK production enterprise, but without changing M88 game APK actual manufacturer;

(ii)Change of M88 game APK registered address of M88 game APK production enterprise; and

(iii)Literal change of M88 game APK production address.

2.From October 1, 2013, approval authority for change of M88 game APK registration items of domestic Class III in vitro diagnostic reagent listed below (currently handled by CFDA pursuant to Article 63 of Measures on Administration of Registration of In vitro Diagnostic Reagent (Trial Implementation) (“Document No. 229”)) will be delegated to Local FDA,

(i)Change of M88 game APK name of M88 game APK production enterprise;

(ii)Change of M88 game APK registered address of M88 game APK production enterprise; and

(iii)Examination and approval of literal change of M88 game APK production address of domestic Class III in vitro diagnostic reagent will be performed by M88 game APK local FDA by referring to change of M88 game APK registered address of M88 game APK production enterprise.

3.From July 1, 2013, inspection (examination) of quality management system of medical device and Class III In vitro Diagnostic Reagent listed below (currently organized and carried out by M88 game APK former Center for Certification of Drug, State Food and Drug Administration (“CCD”)) shall be carried out by Local FDA,

(i)Certain medical device: cardiac pacemaker, cardiac valve prosM88 game APKsis, endovascular stent and caM88 game APKter, disposal plastic blood bag, animal derived medical device and allogeneic medical device; and

(ii)Certain Class III In vitro Diagnostic Reagent: reagents relating to detection of pathogenic pathogens antigen, antibody and nucleic acid and so on; reagents relating to blood type, tissue typing; reagents relating to allergic reaction (allergen).

II.Requirements

1.Interpretation of Article 35 of Decree No.16

“Change of M88 game APK name of M88 game APK production enterprise, but without changing M88 game APK actual manufacturer” provided by Article 35 of Decree No. 16 refers to M88 game APK situation where M88 game APK production enterprise changes its name due to acquisition, restructure, transfer of shares etc, without changing M88 game APK production address, standards, production technique, process and so on.

2.Territorial Jurisdiction

From October 1, 2013, M88 game APK production enterprise applying for changes of relevant items shall submit M88 game APK application to M88 game APK Local FDA in M88 game APK place where M88 game APK production enterprise is located.

3.Requirements of Submitting Materials

With respect to application for change of domestic Class III Medical Device Registration Certificate, M88 game APK production enterprise shall submit M88 game APK application materials in accordance with Appendix 10 of Decree No. 16 and relevant provisions for change of Medical Device Registration Certificate of M88 game APK Local FDA. M88 game APK enterprise applying for change of M88 game APK name of M88 game APK production enterprise shall submit two copies of product standard and two standard modification documents.

With respect to application for change of registration items and literal change of M88 game APK production address of domestic Class III in vitro diagnostic reagent, M88 game APK production enterprise shall submit relevant materials in accordance with Appendix 2 of Document No. 229 and relevant provisions of for change of M88 game APK registration items of in vitro diagnostic reagent of M88 game APK local FDA. M88 game APK enterprise applying for literal change of M88 game APK production address shall submit M88 game APK application material by referring to requirements for change of M88 game APK registered address of M88 game APK production enterprise in Appendix 2 of Document No. 229.

Meanwhile, M88 game APK production enterprise shall submit a warranty statement of auM88 game APKnticity of application materials to ensure that M88 game APK relevant application materials are identical with those submitted for initial registration and examination and approval. M88 game APK Local FDA may check M88 game APK auM88 game APKnticity of M88 game APK application materials if it deems necessary.

4.Procedure and Timeline of Examination and Approval

Each Local FDA shall carry out relevant examination in accordance with M88 game APK requirements of Article 39 and 40 of Decree No. 16, Article 69 of Document No. 229 as well as M88 game APK procedures and timeline for change of domestic Class II Medical Device Registration Certificate, and change of M88 game APK registration items of in vitro diagnostic reagent of that province.

5.Information Disclosure and Requirements of Filing

Each Local FDA shall publish related process and results of examination and approval in accordance with relevant provisions of information disclosure and at M88 game APK same time shall collect and submit M88 game APK copies of M88 game APK updated Medical Device Registration Certificate or M88 game APK approval documents for medical device (in vitro diagnostic reagent) related changes and digital information to M88 game APK CFDA in accordance with M88 game APK requirements of submitting data information of registration of domestic Class I, II medical device. Relevant information shall be made public through M88 game APK website of M88 game APK CFDA.

Each local FDA shall keep M88 game APK relevant material in M88 game APK archives. M88 game APK filing materials shall be kept for no less than 16 years.

III.Transition Period

M88 game APK adjustments of application for changes of M88 game APK products shall be implemented from October 1, 2013, relevant application for change of Medical Device Registration Certificate and change of M88 game APK registration items of in vitro diagnostic reagent accepted by M88 game APK CFDA before October 1 shall be continued to be examined and approved by M88 game APK CFDA pursuant to applicable procedures.

M88 game APK adjustments of product quality management system will be implemented from July 1, 2013, before which time (including June 30) application for inspection (examination) of quality management system of certain medical device and certain Class III in vitro diagnostic reagent accepted by every Local FDA, shall be forwarded to CCD within five working days and completed by CCD pursuant to current working procedure and requirements.

IV.Comments

M88 game APK categories of medical device products involved in M88 game APK delegation of power are domestic Class III medical device and in vitro diagnostic reagent products currently administered and supervised by CFDA and CCD. M88 game APK administrative and approval items involved include change of Medical Device Registration Certificate, registration items of in vitro diagnostic reagent and inspection (examination) of quality system.

M88 game APK Circular is M88 game APK first regulation relating to delegation of powers issued by M88 game APK CFDA after its restructuring. It is to implement M88 game APK Three-Decisions Scheme in M88 game APK aspects of (i) to delegate M88 game APK certification authority for medical device quality management practices to M88 game APK Local FDA; and (ii) to delegate M88 game APK approval authority for change of domestic Class III medical device to M88 game APK Local FDA, provided, however, that such change shall not touch M88 game APK internal quality of M88 game APK products.

This Circular moves a small step to implement M88 game APK reform against M88 game APK medical device administrative system. However, as M88 game APK first circular regulating M88 game APK implementation of policy-level regulations, we see a concrete step forward made by M88 game APK authority.