The impact of CFDA’s latest directive on overseas medical device manufacturers

On September 30th, 2016, China’s Food and Drug Administration issued a “Notice of the Release of the Second Batch of Medical Devices Exempted from Clinical Trials by the General Administration” (2016, No. 133) and began implementation on the date of publication. There were 267 items of Class II medical equipment listed that are exempted from clinical trials and 92 items of Class III medical equipment; compared to the end of 2014, 175 and 13 items, were added respectively.

According to the article’s provisions:

Medical devices that have been listed for many years, with clear mechanisms and working principles and whose standard types and production processes are mature and that have proven their safety and effectiveness through non-clinical performance evaluations, are eligible to apply for exemption. When applying for a product to be included in the directory of medical devices, the company applying can submit a written application to be exempted from submitting clinical trial data. Instead, they can submit a comparative description of the product comparing it with similar listed products. The contents of the comparative description should include at least the working principles, the material which theproduct is made from, its structure, main technical performance indicators, disinfection / sterilization methods (if any), intended use, etc.

The biggest influencing factor for the import and export of medical equipment, apart from market demand, is administrative supervision. The regulatory systems and the provisions of the directory of the China Food and Drug Administrationare based on the actual situation at the time and can be adjusted for future trends accordingly. With regards to this CFDA publication “Directory of Medical Devices, Exempted from Clinical Trials”, Carrie, a Senior Project Manager at the Life Sciences Translation Team of EC Innovations, said: “CFDA has been experimenting with a trial of the‘Directory of Exemption for the Submission of Clinical Trial Data for Class II Medical Equipment’ (Trial Implementation) since 2011, effectively attempting to regulate the chaotic Chinese medical equipment import market at that time.The current documents have relaxed the registration categories, expanded the numbers of the various types of medical devices and have gradually improved the situation for the importing of overseas medical equipment into the Chinese market.”

Following the further expansion of the directory of medical devices that are exempted from clinical trials, it has become easier for overseas medical device manufacturers to enter the Chinese market. In addition, the cost has also been reduced, as shown in the following points:

  1. May help more medical equipment manufacturers to reduce costs.

CFDA Medical Device Management Loophole Restoration:Per the regulations for “Medical Device Registration”, before 2004; as long as foreign companies obtained the ISO9000 standard series certification (or equivalent performance standard), and their products were approved by the competent authorities in their country of origin to prove the safety and effectiveness of these medical devices, they could apply for an exemption to submit clinical trial data. This provision provided convenient export facilities to European and US medical device manufacturers. However, since 2011, ever since the CFDA trial on “Directory of Exemption on Submission of Clinical Trial Data for Class II Medical Equipment (Trial Implementation)”began, this convenient door has been closed.

Opportunity: Following the increase in exemption directory items from the initial 21 categories of medical equipment, to the current 267 Class II and 92 Class III pieces of medical equipment, it has not only helped to avoid wasted efforts within the CFDA, but has also effectively reduced unnecessary costs incurred on clinical trials by overseas medical device manufacturing companies.

  1. More medical devices that meet the exemption conditions can quickly enter the Chinese medical device market.

To ensure the safety and effectiveness of medical devices, clinical trials are an essential part of the registration process for such medical devices not listed in this Class II & III catalog. It takes at least 8 years from the comprehensive analysis of clinical trials of the devices and the risk levels derived from comparative analyses until the final testsare completed. This catalog further expands the range of clinical trial exempted medical devices registered, which not only saves the cost of translating large amounts of clinical trial protocols and clinical trial reports, but also prolongs the duration of the relevant patent protections.

Medical devices registered for the exemption are required to submit a large number of registration declarations within a short period of time, such as exemption comparison documents and materials, undertakings, and product description documents, etc. This requires not only the abilities and resources of a translation company to manage and deliver a large amount of translation work in a short period of time, but also the need to meet the national standards for the quality of the translations of the reviews.

Tips for medical equipment manufacturers choosinga language service provider:

  1. A medical device project should be assigned to one language provider to manage.

Once a file is updated, the manufacturer may be faced with the problem of handling registration changes. If a particular medical device translation project has been assigned to one language service provider, as this language translatoris familiar with the original provisions and the entire project, all the contents of the changes can be quickly completed according to the corresponding translation of the documents and the technical translation of any supplementary information. This can help effectively reduce costs in completing the certification to achieve faster access to the target market.

  1. Choose a long-term stable language service provider.

According to the “Medical Device Registration Management Regulations” (National Food and Drug Administration Order No. 4) provisions: The registration certificate is valid for 5 years, extension may be carried out by submission of a product renewal registration, product filing and other declarations. Combined with the registration for exemption for clinical trials for new products, it is required to submit the declarations of the comparison with different varieties and other similar products as to their working principles, product quality, structures, main technical performance indicators, etc. Cooperation with a stable, long term, language service provider can help customers to save costs and improve efficiency through the re-using and updating their translation memory.

About EC Innovations:

EC Innovations is a global provider of high quality, customized translation and localization services, focused on advancing the global reach of leading multinational companies. ECIhas established 10 strategic office locations around the world, serving260 countries and regions. EC Innovations has passed the ISO9001 and ISO17100 quality certifications, the SAP language partner certification, and several other certifications.


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