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CFDA China-The Booklet

Medical Device Registration in China

This Publication provides information about our Services for Medical Device Registration in China

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Content

1. General Information about Chinese market for medical devices .............................. 3

2. Legal provisions and guidelines for medical device export to China ........................ 3

2.1. National Standards and Industry Standards ....................................................... 3

3. The China Food and Drug Administration - CFDA ................................................... 4

4. Process of medical device registration at CFDA .................................................... 4

4.1. Introduction ......................................................................................................... 4

4.2. Application .......................................................................................................... 5

4.3. Product Testing .................................................................................................. 6

4.4. Evaluation of product tests and product registration ........................................... 6

4.5. Requirements for successful medical device registration at CFDA .................... 6

5. Our Services ............................................................................................................. 8

6. CFDA Made easy – MPR China Certification GmbH ................................................ 9

6.1. Executive Board ............................................................................................... 10

6.2. Our Team ......................................................................................................... 10

6.3. Contact Details ................................................................................................. 12

7. Legal ....................................................................................................................... 13

7.1. Copyright Notice ............................................................................................... 13

7.2. Disclaimer ......................................................................................................... 13

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1. General Information about Chinese market for medical products

The People’s Republic of China is a highly attractive and important market for manufacturers of medical devices and products. In 2012 the Chinese market for medical devices was valued at over 25 Billion Dollars (US). With China’s massive population becoming more affluent and health conscious, their willingness to spend money on health care has increased and they have seen high double digit sales growth rates year after year. According to the China Association for Medical Devices (CAMDI), more than 60 percent of the existing medical equipment is technologically antiquated using technology 80 years or older. All of this combined with steadily growing acceptance of the importance of Western medicine, viewed as complimentary to the Traditional Chinese medicine, makes the Chinese market potential huge. With both the Chinese population and the healthcare industry looking to improve their quality of care, China has become the number one market for International manufacturers of medical devices and products.

2. Legal provisions and guidelines for medical device export to China

To sell into China most medical devices will be required to be certified by the China Food and Drug Administration (CFDA). Products that need to be certified by CFDA are listed in the official CFDA database, which currently lists more than 700 devices and is being updated regularly. The regulatory system for registration of medical devices is based on the Provisions of the Chinese State Council and on the Normative CFDA Documents, which contain detailed rules for medical device registration and licensing. These include the Regulations for the Supervision and Administration of Medical Devices from April 1, 2001 and the Provisions for Medical Device Classification from April 5, 2000. 2.1. National Standards and Industry Standards

Tests are required for CFDA certification of certain products. With few exceptions the tests will usually need to be done by an accredited test laboratory in China. The tests will be performed in accordance to the Chinese National Standards (known as Guobiao or GB for short). If there is no GB standard in place, test norms are given by an Industry Standard (referred to as “YY”). An example of a relevant medical device standard would be GB 9706.1-2007 referring to an electrical standard for a medical device. Chinese regulations and standards that are needed for certification are similar to the International EC (European Commission Standards) Standards. An example would be GB 9706.1-2007 which directly corresponds with EC 60601-1:1995, although the requirements of CFDA for the particular test reports would need to be checked in every case individually.

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3. The China Food and Drug Administration - CFDA Scandals involving Governmental authorities and institutions that are responsible for ensuring food and drug safety in the People’s Republic of China often make headlines with negative news. In years past, the media has reported on the tainted milk powder scandal that killed and sickened infants, corruption at the highest levels of politics and in 2003 it was revealed that the head of the State Food and Drug Administration (SFDA) had accepted bribes from several large pharmaceutical companies for years. In turn, the SFDA approved and registered their drugs and medical devices without requiring the necessary administrative procedures or product testing. After the corruption scandals emerged the SFDA was reorganize, but more serious scandals continued (tainted heparin, contaminated food) with numerous deaths. In 2008, the institution was reorganized again and was put under the control of the Chinese Ministry of Health (MOH). In an effort to start “a new” and separate itself from past scandals, the SFDA was renamed CFDA in March of 2013. The authority now has more internal structures and over-sight than ever before.

4. Process of medical device registration at the CFDA

4.1. Introduction

The definition of medical devices that can be found in the Provisions for Medical Device Classification from 5 April 2000 is based on the Regulations for the Supervision and Administration of Medical Devices (Guideline 93/42/EWG, Article 1, Paragraph 2, Iss. 2007). This is:

Any instrument, apparatus, appliance, material, or other article, whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:

1. Diagnosis, prevention, monitoring, treatment or alleviation of disease 2. Diagnosis, monitoring, treatment, alleviation of or compensation for an

injury or handicap conditions 3. Investigation, replacement or modification for anatomy or a physiological

process 4. Control of conception.

It may be difficult to determine whether CFDA certification is needed, in addition to that, certain medical devices also needed CCC certification (China Compulsory Certificate). In April 2013 the superior authority of the CFDA and the AQSIQ (The General Administration of Quality Supervision, Inspection and Quarantine) decided not to require CCC

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certification for some products. With all of these changes, and continued changes, it is important to carefully check the most up to date regulations and how they apply to a particular medical product. After verification that a product is indeed a medical device which will need to be certified with the CFDA, the application process can proceed. 4.2. Application

Similar to the EU and US required Standards, a medical device has to be classified into one of three risk categories or classes (I-III). The definition and classification criteria of medical devices are based on the European Council Directive 93/42/EEC of June 14, 1993. The distinction between class IIa and IIb in the Council Directive 93/42/EEC with all the resulting conclusions for conformity assessment procedures does not exist in the Chinese regulations. For this reason, the CFDA alone is responsible to draw the line in the middle risk class, to estimate potential hazards and to assign all necessary approval procedures. For each product class the CFDA requires specific administrative procedures, product tests and/or clinical trials. Class I devices may only pass relatively simple administrative and approval procedures to seek authorization for Chinese market, while class II and III devices partially need product testing and clinical trials:

▪ For Class I devices, safety and effectiveness can be ensured through routine administration, so product tests and clinical trials in China are usually not required.

▪ For Class II devices, safety and effectiveness can be ensured through routine administration and product testing. Some devices require clinical testing as well to seek authorization for Chinese market.

▪ Class III devices which are implanted into the human body or are used for life support or sustenance pose potential risk to the human body and are strictly controlled by mandated tests and clinical trials to ensure safety and effectiveness.

After the application documents and all necessary materials are submitted to the CFDA, they are reviewed by the authority and the classification submitted by the applicant will be confirmed, corrected or in extreme cases rejected. The CFDA decides if any additional technical and/or legal documents have to be provided. At this point they will call out the required tests and/or clinical trials needed. In this stage, extensive communication between the CFDA, the applicant and respectively their agent will be ongoing. Please note that only after handing in all application documents will the CFDA decides whether a medical device registration is possible or not (usually within 30-60 days after application). There is also the possibility that the application is rejected by CFDA. If rejected, an explanation and statement will be provided to the applicant. Consequently, it is impossible to know with 100% certainty if the application, categorization or registration

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will be accepted by the CFDA. As with any governmental agency in any country, there would be specific reasons given and possible recourses. 4.3. Product Testing

If the CFDA decides that product testing is necessary, the tests generally would need to be done by an accredited test lab in China. Typically, product tests and/or studies that have been made by foreign laboratories are not accepted by the CFDA, with the exception of some Class I medical devices. Please note, for certain Class III devices, the CFDA may also require a clinical trial. During the product testing phase, there is extensive communication between the authority and the applicant and their agent at this point. There is low transparency regarding accredited or notified bodies, therefore it is important to have good, long-standing relationships with key personnel in the certification centers and test labs in China as well as knowledge of the local business environment. Proper, timely communication at this point is essential in the success of product testing, and it is important that the device manufacturer take an active role in responding to all of the necessary questions, and requests.

4.4. Evaluation of product tests and product registration

After the product tests and/or clinical trials are completed the CFDA will evaluate the results and submit a technical and administrative report. The CFDA will perform a final technical and administrative review, and a final decision will be made as to whether the product or device will receive approval for licensing, certification and registration. At this point the product may be freely imported and sold throughout China. The certification is good for five years, at which point an extensive review is required. 4.5. Requirements for successful medical device registration at the CFDA

Experience shows that the communication between the applicant, their agent, the test laboratories and CFDA is crucial to the success of the whole certification process. The authority frequently change the requirements for the admission procedure or it sets additional conditions, at which point immediate short-term action is needed and the coordination of the certification process becomes more complicated. Most of the documents that are issued by the CFDA are only available in Chinese and all information regarding the medical device must be translated into Chinese for the authority as well. It is important to consider the complexities of the process, language barriers, cultural differences and the necessary relationships/experience when choosing a service provider. China Certification Corporation maintains excellent long-standing relationships with all Chinese institutions that are relevant in the course of CFDA certification process and covers all services that are necessary.

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Possible process of medical device certification at CFDA

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5. Our Services

The certification and registration of medical products with the CFDA can be an extensive and drawn-out process. A large number of documents, specifications and reports must be provided, and intensive on-going communication with the certification bodies and testing laboratories is needed. Conducting the registration from overseas can be more difficult due to communication problems and the changes that may arise regarding the requirements of the regulatory bodies. By authorizing China Certification Corporation to register your device, your CFDA certification will be managed professionally and smoothly. Choosing China Certification Corporation for CFDA certification of your medical device you ensure a professional and hassle-free certification. What we can do for you:

▪ China Certification Corporation will inform you which application documents are required and then prepare all of the documents. All application documents will be translated in Chinese, as required by the CFDA.

▪ We pay all fees charged by the Chinese authorities. Through our offices in Beijing and Shanghai we take care of the direct communication with the CFDA and the testing laboratories.

▪ We apply at the CFDA with all related documents and advise you regarding the classification of your medical device in Class I, II or III.

▪ We advise you in all necessary steps for preparation and execution of product testing.

▪ We will keep you informed about the certification progress with regular updates.

▪ We take care about the whole customs clearance of your test products and pay all import duties and taxes.

▪ We handle the product testing, including the payment of test fees, the exchange of documents, the communication with the test laboratory and the evaluation of the Chinese test reports.

▪ We obtain and forward the Chinese CFDA certificate for your products.

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6. CFDA Made easy – MPR China Certification GmbH Since 2005, China Certification Corporation has been helping companies around the world to obtain CCC and CFDA certification. The Headquarters of MPR China Certification GmbH is based in Frankfurt, Germany. Through our offices in Chicago and Anaheim we also serve the needs of our clients in the USA, Canada and Mexico. Our offices in Shanghai and Beijing cover the Chinese market and provide direct communication with the Chinese authorities and test labs.

We combine Western and Chinese strengths in our International management team, providing a multi-cultural understanding that is demonstrated in our work with clients, partners and certification authorities. Our highly qualified International team of China Certification Corporation is looking forward to answering all your questions regarding CFDA. Our strengths include:

• Years of personal relationships with key certification authorities and testing laboratories.

• Our team combines specialized expertise and well-developed communication skills. Our consultants will share with you the exact know-how you need, while still always willing to carefully listen to you. They are experts and together with you, they will develop the best solution for your CFDA project.

• Fast certification: our service packages ensure a very fast certification process so that you can meet your deadlines.

• Excellent quality: the quality of our services and certification process is very important to us. Therefore, we ensure that the entire process can be tracked at any time and set great value on quality assurance.

Please contact us for your individual CFDA certification plan. Our quotes are transparent and include all related costs. You want to have a reliable and loyal partner on your side who can advise you professionally and discreetly with your CFDA certification, with China Certification Corporation you get the support you need.

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Call us at (773)-654-2673 (for US clients) or +49 69 2713769 13 (for European clients) or send an email to usa@china-certification.com or europe@china-certification.com. 6.1. Executive Board

Mr. Julian Busch and Mr. Robert Wolf, Managing Directors of MPR China Certification GmbH

6.2. Our Team

Our team in Frankfurt

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Our team in Shanghai

Our team in Beijing

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Our team in the USA

6.3. Contact Details

Please do not hesitate to contact us if you have any questions about medical device certification for Chinese market.

MPR China Certification GmbH

Kaiserstr. 65 D-60329 Frankfurt am Main, Germany

Tel.: +49 69 271 37 69 150 Fax: +49 69 271 37 69 11 E-Mail: info@china-certification.com Web: www.china-certification.com

China Certification Corporation

Chicago office: 111 West Jackson Blvd, Suite 1700 Chicago, Illinois 60604-1210, USA Anaheim office: 2400 East Katella Avenue, Suite 800 Anaheim, California 92806, USA

Chicago office: Tel.: +1 (773) 654-2673 Fax: +1 (773) 654-2673 Anaheim office: Tel.: +1 (714) 312-5966 Fax: +1 (714) 312-5966 E-Mail: usa@china-certification.com Web: www.china-certification.com

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Detang Germany Business Consulting Shanghai Co., Ltd. Guozhan Road 839, Huadian Plaza, Room 901, Pudong, 200126 Shanghai, P.R. China

Tel.: +86 (0)21 6163 2960 -889 E-Mail: info@china-certification.com Web: www.china-certification.com

Beijing Detang Dingfeng International Investment Consulting Co., Ltd. 19th Floor, No. 6, Workers’ Stadium Road N., Chaoyang District, 100027 Beijing, P.R. China

Tel.: +86 (0)1 0864 82669 E-Mail: info@china-certification.com Web: www.china-certification.com

Zhide Network Technology Chengdu Co., Ltd. IFS, Hongxing Road, Section 3, No. 1, Room 2312, 610021 Chengdu, Sichuan, P.R. China

Tel.: +86 (0)28 6232 8781 E-Mail: info@china-certification.com Web: www.china-certification.com

7. Legal

7.1. Copyright Notice

CFDA China - The Booklet - All rights reserved by China Certification Corporation. No part of this document may be reproduced in any form, by photocopying or by any electronic or mechanical means, including information storage or retrieval systems, without permission in writing from China Certification Corporation. The sharing and forwarding of this publication is permitted only if the document is transmitted in complete and unchanged form. 7.2. Disclaimer

This document was created with care and diligence according to the current standards in place at the time of writing. However, China Certification Corporation makes no representations or warranties with respect to the accuracy or completeness of the contents of this work. The advice and strategies contained herein may not be suitable for every situation. If professional assistance is required, the services of China Certification Certification itself should be sought.