Specially know how to determine the classification of medical devices in china

Editor's Notes

• #3: A. overview, B. step by step, C., D. significant, some may care a lot. E. based on our experience, may not professional, but must be helpful
• #8: According to CFDA regulations, medical devices managed in China are classified into three classes in terms of the risk level to ensure the safety and effectiveness of the device. The risk level is comprehensively evaluated by the intended use, structural features and intended for use of the device. Some novel devices have to apply for the classification determination to NIFDC to confirm its category & classification. Intended use, structural features more important, intended for use = use method, short/medium/long term . Need 2 weeks to 1 month.
• #9: In order to achieve standardized and informatization management of medical devices, China has drawn up unified category code of medical devices.Most foreign enterprises don’t know the category code of medical devices, and cannot use the category code to search the risk level of the products.In order to help foreign enterprises to solve the problem, CIRS makes a summary about the category code of medical devices as following:Note: MD Code is discontinuous
• #10: In order to achieve standardized and informatization management of medical devices, China has drawn up unified category code of medical devices.Most foreign enterprises don’t know the category code of medical devices, and cannot use the category code to search the risk level of the products.In order to help foreign enterprises to solve the problem, CIRS makes a summary about the category code of medical devices as following:Note: MD Code is discontinuous
• #11: In order to achieve standardized and informatization management of medical devices, China has drawn up unified category code of medical devices.Most foreign enterprises don’t know the category code of medical devices, and cannot use the category code to search the risk level of the products.In order to help foreign enterprises to solve the problem, CIRS makes a summary about the category code of medical devices as following:Note: MD Code is discontinuous
• #15: National Institutes for food and drug control
• #20: The first priority of medical device company is to define the category of medical device. Then how to define the category of medical device? China carry out the policy of classification administration of medical devices, and the medical devices are divided into three kinds as Class I, Class II and Class III according to the degree of risk. The manner of defining determinism has followed several ways： Search the catalogue of medical devices classification, CFDA database (refer to the latest data) Conduct the category definition according to the decision table of medical device classification of《Provisions for Medical Device Classification》. Submit the application of category definition of medical devices. 1. How to find the catalogue of medical devices classification? CFDA website will publish the catalogue of medical devices classification and notification of product classification non-scheduled. You can find the basic information of the product which has been registered or recorded by searching the CFDA database, and define the category by learning the related products. 2. What is the《Provisions for Medical Device Classification》? The provisions are meant to direct the formulation of《Catalogue of Medical Device Classification》 as well as to determine the classification of newly registered products. CFDA has issued the《Provisions for Medical Device Classification》(CFDA No.15) on Jul 14, 2015, and the provision shall put in force from Jan 1, 2016, also abolish the《Provisions for Medical Device Classification》promulgated on Apr 5, 2000 (the former State Food and Drug Administration decree No.15) shall be repealed simultaneously. The decision table of medical device classification of《Provisions for Medical Device Classification》provide the standard of determination of product category. 3. How to apply for defining? Note: Classification information system is refer to Information System of medical devices Classification Definition Classification is the first step of medical device towards marketing. CIRS has collecting the classified catalogue, notification of classified definition and exposure draft of classification which published by CFDA over the years, and form a classified catalogue system of medical device which can help you search the category of your product. CIRS has a great deal of experience in technical documentation of classified definition, and has completed the classification of multiple products. For the new product which has not been listed in the classified catalogue yet, you can apply for classification or apply for registration as Class III medical device. Company can make a choice according to the actual conditions.
• #21: National Institutes for food and drug control
• #22: 列如 纳米金属银材料制成的医疗器械，2004年，国家局曾发文将由纳米级金属银材料制成的“纳米银妇用抗菌器”作为Ⅱ类医疗器械管理。目前已有近10个由纳米级金属材料制成的产品获得Ⅱ类医疗器械注册证上市销售。鉴于纳米级材料的特性，我局决定从发文之日起将纳米生物材料类医疗器械（如纳米金属银材料制成的医疗器械）调整为Ⅲ类医疗器械管理 国家局曾在《关于尿沉渣计数板等37种产品分类界定的通知》（国食药监械〔2004〕84号）中，明确食道、肠道吻合器作为Ⅱ类医疗器械管理，肠道吻合夹作为Ⅲ类医疗器械管理。由于吻合器和吻合夹是作为一个完整产品销售和使用，为便于监管，现决定将肠道（含食道）吻合夹调整为Ⅱ类医疗器械管理，原注册证在有效期内可继续使用。 氢氧化钙糊剂，主要用于护髓与垫底材料、盖髓剂或根管充填的封闭剂，按照三类医疗器械管理。分类编码6863
• #23: Medical device manufacturer are not required to register for class I medical devices under the new medical device regulations (known as decree No. 650 ), and only required to record in CFDA, and the record keeping effects permanent once it approved by CFDA. It significantly simplifies the administrative approval process and reduces the cost and duration for applicant. CFDA have modified the classification of class I medical devices and issued the "Catalogue of class I medical devices" on May 30th 2014. Any devices not listed in this catalogue will be considered as non class I medical devices. There are some devices deemed to be no longer managed as class I medical devices in China: Foreign devices manufacturer need to understand that you are required to update your registration if the classification of your product changed. If you would like to confirm the new classification of your medical device and how to comply with it, please join CIRS regulatory assistant program (MDRAP).
• #24: 继续有效，但若期间产品发生变化，如原材料改变、说明书变化、代理人改变等，需向CFDA申请变更。 管理类别由低类别调整为高类别　　（一）对于已获准注册的医疗器械，生产企业应当按照《医疗器械注册管理办法》第三十五条的规定申请变更重新注册。对于按规定申请变更重新注册的，在重新注册审批决定作出之前，其原注册证在其有效期内继续有效。未按规定在6个月内申请重新注册的，原注册证书不得继续使用。
• #25: National Institutes for food and drug control
• #31: MDRAP
• #33: Need help, find our website, click FREE PROPOSAL