New Catalogue on Medical Devices Classification On 31 August 2017, the China Food and Drug Administration (“CFDA”) promulgated the Catalogue on Medical Device Classification (2017 Edition) (“Catalogue 2017”). The Catalogue 2017 will be implemented on 1 August 2018. The currently valid catalogue, i.e. Catalogue on Medical Device Classification (2002 Edition) (“Catalogue 2002”) will be abolished on 1 August 2018. During the period from 31 August 2017 to 31 July 2018 (“Interim Period”), Catalogue 2002 will still be valid for registration and recordal of medical device in China. Along with the Catalogue 2017, the CFDA also promulgated on the same day a Circular No.143 related to the Matters for the Implementation of Catalogue 2017 (“Circular No.143”). Circular No.143 provides guidelines on how to apply the Catalogue 2002 or Catalogue 2017 during the Interim Period. As an exception, the Catalogue 2017 is not applicable to in vitro medical devices or kit products, which shall be subject to separate regulations of the CFDA. In addition, the related regulations with respect to the classification of Class I medical devices promulgated by the CFDA, especially Announcement related to the Promulgation of Catalogue for Class I Medical Devices, its implementing rules will still be valid. As of 1 August 2018, in case of any discrepancy between the Catalogue 2017 and these regulations on Class I medical devices, the Catalogue 2017 shall prevail. 1. New Changes with the Catalogue 2017 Considering that the Catalogue 2002 was promulgated more than 10 years ago and could hardly cope with the rapid development of medical devices, especially in terms of its contents, logic structure, integrity of products and coverage of new products, the CFDA has modified the structure of the Catalogue 2002. The main modification of the structure is in the Catalogue 2017 is described as follows: (1) Dividing product classification into two more specific columns, i.e. Category I Product and Category II Product. Category I Product can be further classified into more detailed Category II Products. (2) Adding two new columns, i.e. Product Description and Expected Usage. These two columns stipulate respectively the basic description and the expected usage of the medical devices in the same class as guidance for the applicant to differentiate the classification of medical devices during the registration or recordal procedure. The structures of both Catalogue 2017 and Catalogue 2002 are listed as below as an example. Sample Structure of Catalogue 2017 Sub-catalogue Item Category I Product Category II Product Product Description Expected Usage Example of Product Name Class Management Orthopedics Surgery Device 01 Knife for orthopedics surgery Knife for osteotomy - - - - Knife for reaming - - - - Sample Structure of Catalogue 2002 Subcatalogue Item Product Classification Example of Product Name Class Management Orthopedics Surgery Device 01 Knife and awl for orthopedics surgery - - Catalogue 2017 contains 22 sub-catalogues (compared with 48 sub-catalogues in the Catalogue 2002): Surgery Devices 01. Active Surgery Device 02. Non-active Surgery Device 03. Nerve and Vessel Surgery Device 04. Orthopedic Surgery Device Active Devices 05. Radiotherapy Device 06. Medical Imaging Device 07. Medical Diagnosis and Monitor Device 08. Respiration, Anesthesia and First Aid Device 09. Physiotherapist Device 10. Transfusion, Dialysis and Extracorporeal Circulation Device 11. Medical Device Sterilization Device 12. Active Implantable Device Non-active Devices 13. Non-active Implantable Device 14. Injection, Nursing and Protective Device 15. Patient Carrying Device Clinical Departments Related Devices 16. Medical Device for Ophthalmology Department 17. Medical Device for Stomatology Department 18. Medical Device for Department of Obstetrics and Gynecology Medical Rehabilitation and Traditional Chinese Medicine Devices 19. Medical Rehabilitation Device 20. Traditional Chinese Medicine Device Medical Software 21. Medical Software Clinical Examination 22. Clinical Examination Device Under the sub-catalogues, medical devices are categorized into 206 kinds of Category I Products. Under the Category I Products, medical devices are further sub-divided into 1157 kinds of Category II Products. The examples of Product Name¹ have been expanded from 1008 to 6609 ones. We list the major changes between Catalogue 2017 and Catalogue 2002 as below. Content Catalogue 2017 Catalogue 2002 Number of Sub-catalogue 22 43 Number of Product Classification 206 kinds of Class I Products 1157 kinds of Class II Products 260 Number of Examples of Product Name 6609 1008 Number Downgraded Medical Device in Class Management 40 - 2. Interim Period Considering the substantial changes to the Catalogue 2002, the CFDA set an Interim Period of around 1 year before the Catalogue 2017 is implemented. During the Interim Period, the application of the Catalogue 2017 for new registration or renewal application shall follow the following principles: – if the application for registration of new medical device or renewal is accepted and approved by the CFDA prior to 1 August 2018, the registration certificate of medical device (“Certificate”) will be issued based on the Catalogue 2002; – if the application for registration of new medical device or renewal is only accepted but not approved by the CFDA prior to 1 August 2018, and if the class of the medical device is changed, the Certificate shall be issued based on the Catalogue 2002 (the class and sub-catalogue number in the Catalogue 2017 shall be specified in the Certificate); – if the application for registration of new medical device or renewal is only accepted but not approved by the CFDA, and if the class of the medical devices is not changed, the Certificate shall be issued based on the Catalogue 2017 (sub-catalogue number in the Catalogue 2002 shall be specified in the Certificate). After the Interim Period, all applications shall be submitted and examined based on the Catalogue 2017 (subcatalogue number in the Catalogue 2002 shall be specified in the Certificate). After the Interim Period, all applications shall be submitted and examined based on the Catalogue 2017. After the Interim Period, the Certificate/Recordal Notice already issued prior to the Interim Period shall be still valid. Any further renewal of the Certificate shall be based on the Catalogue 2017. In addition, for those medical devices that were subject to recordal procedure previously but shall be subject to registration procedure according to the Catalogue 2017, applicants shall complete the registration with the CFDA prior to 31 August 2019. 3. Impact on manufacturing/trading licence As from 1 August 2018, if a medical device manufacturing company applies for a new medical device manufacturing licence with the Certificate issued based on the Catalogue 2017, the CFDA shall issue the manufacturing licence in which the products specified in the manufacturing scope shall be identical to the names of the Category I Products on the Certificate. As from 1 August 2018, if a medical devices manufacturing company applies for the modification of its existing manufacturing licence by modifying the manufacturing scope or adding new products to the existing products manufacturing scope, the CFDA shall specify the manufacturing scope and product to be manufactured according to the Catalogue 2012 (for existing products) and Catalogue 2017 (for new products) respectively. After all the products under such manufacturing licences are subject to the Catalogue 2017, the CFDA will no longer be required to make such a distinction. The same principle also applies to the application of new medical devices trading licence and Class II medical devices trading recordal. Foreign invested companies shall pay attention to the new development for medical devices classification as specified in Catalogue 2017 for registration or recordal of medical devices according to the Circular No.143 and the Catalogue 2017. ¹Example of Product Name refers to a number of normative and typical names of medical device which are all in compliance with Naming Rule for the Common Name of Medical Device. The example of Product Names can be used as reference for applicants to name medical devices.