On the 25th of June 2018, the Chinese Ministry of Justice published a new version of the Chinese Medical Device Regulation Order 650. The new regulation order is open for comments before final approval. This is the 2nd amendment, a follow-up to the 1st amendment released in late 2017. New elements have been added to the 2nd amendment to further complete China’s regulatory framework, with high-level directions and contents remaining consistent.The
following highlights, in terms of improving the market authorization holders (MAH) system, reforming clinical evidence requirements, optimizing the approval procedures, and strengthening post-market surveillance are outlined below.
Market Authorization Holder (MAH) System
The new Market Authorization Holder (MAH) system replaces the OEM/subcontractor manufacturing system. The MAH system in China began in the pharmaceutical field in late 2015, and the local authority intends to extend its application to the medical device field. In the past, China strictly controlled subcontract manufacturing and required both a production certificate and a registration certificate to be listed as a legal manufacturer. This rule led to heavy up-front costs for small companies and discouraged innovation. Guangdong and Tianjin have limited trial sites to the “free trade zone” within the city. While Shanghai is extending the MAH to the entire city. MAH separates license holding from production and outsources services such as: research and development, clinical trials, manufacturing, distribution, and other activities to a 3rd party to optimize resources. The new amendment adds MAH to CNDA regulation management and lays the frame to broaden the applicable geographic areas for the future. MAH is posed with similar responsibilities as legal manufacturer. High risk implantable products, which will be catalogue-based, are not included in the MAH system.
Clinical requirements have been eased
Clinical evidence is a challenge for many companies launching products in China. The new revision may eliminate the need for a Clinical Evaluation Report (CER) as part of the technical file submission phase. For Class I and lower risk class II products, a CER may no longer be required. Class III devices, still require a CER and high-risk implantable devices may also require clinical investigation. These changes may reduce the amount of time and money Domestic companies spend drafting CERs for products that have equivalence to other devices that have been on the market for years. Foreign companies create CERs for European and American markets already, but CNDA requires a specific Chinese submission. If the CER requirement is indeed lifted in the future, it would greatly speed up technical file preparation and reduce costs.
Imported products with clinical investigational data collected in its home country could be used for submission in China as well. Foreign clinical data collected outside of China requires confirmation before being accepted, but there is no limitation on the amount of data that can be submitted. This applies to both retrospective and prospective clinical data. More details about conditions of using overseas clinical data could be found in my blog Update on China's MDR Order. 650.
Fast approval route
There may be more flexibility on test report acceptance. Currently, only test reports issued from CNDA designated local test houses can be used for submission. Requiring foreign manufactures to repeat most of the testing for class II and III products in China. The new amendment proposes that the manufacturer can use in-house self-testing reports for class
I products, while class II and III products have flexible choices of using accredited 3rd party test labs in China or a foreign test lab. This policy shortens the waiting time at Chinese test labs and forces test providers to offer better services and more competitive fees. Good news for foreign companies to have a choice of using international test labs or use existing test reports. The detailed requirements of test lab qualification and selection may be further clarified by CNDA later.
Innovative products could also enter China’s market without home country market approval. To advance innovation promotion, the new amendment exempts imported products’ market approval pre-requisite if they are qualified as innovative. This applies to devices that treat rare or life-threatening diseases with no other effective treatment, and public health emergencies. For these devices, a priority approval route with follow-up
study is granted. Foreign manufacturers could re-strategize their product portfolio in China and consider launching across multiple countries at the same time.
Further emphasis on PMS requirements
One action is to increase post-market surveillance by performing on-site quality inspections, including overseas inspections. The requirement of following the Chinese quality system is the same for both domestic and foreign companies. It means foreign producers also need to be fully aware of China’s GMP requirements, identify the gaps, and get ready for on-site inspections. To accommodate such action, CNDA is aiming to build up a professional inspector team and may introduce 3rd party support. Another highlight is to further clarify and increase the applied penalty scope, fine amount, and extend individual liabilities.
Some other minor changes include relaxed distribution administration for class II products with a requirement that all distribution companies follow China’s GSP regulations. Online sellers of medical devices need to file with CNDA, forbid the import and sale of used devices, remove advertisement approval from CNDA, and include China’s UDI on packaging
Once Order 650 amendment is approved and implemented, we expect to see impacts on various stakeholders from legal manufacturers, market authorization holders, Chinese agents and Chinese health authorities. These changes will lead them to re-consider their market strategy, budget planning, resource allocation and daily operations. More qualified staff and training will be required to stay in compliance.
China is increasingly becoming an important playground for both domestic and international medical device manufacturers. Not only the medical device market is increasing in China, so is the complexity of the regulatory landscape.
Qserve can help you navigate through the Chinese market by offering a wide range of customized services, including building Regulatory strategy plan, Clinical Affairs, CFDA China Agent (Qserve has a local entity in China (WFOE), CFDA registration or CRO services.
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