CFDA is asking the public to comment revisions to China’s Medical Device Regulation Order. 650 in early November 2017, and would like to finalize it in 2018. Order. 650 sets the fundamental regulatory requirements and guidance for medical devices in China throughout their lifecycle. First released in 2014, it replaced its predecessor Order. 276 from year 2000, and was remarked as a substantial reform. In a relatively short 3 years’ time, CFDA looks back to revise its contents, with a claim to keep pace with industry’s development at home and abroad. Leaving those who still digest the old contents and transition puzzles behind, CFDA is taking a new lead and march ahead in 2018.
By reading through the long revision article published, some key changes may draw foreign manufacturers’ attention:
- China Agent role is becoming more demanding
In the new proposal, China agent responsibilities are further clarified and refined. For all foreign manufacturers based out of mainland China, it is always required to appoint a legal representative established in China. Different than European regulations, this legal representation must be a legal entity, not a natural person. In the past, this role is not more than communication and liaison. In the future, China agent would be given more rights and responsibilities. For example, China agent would need to have appropriate quality management, risk prevention and control, and liability compensation capacity. It may assist CFDA to carry out oversee on-site inspection, and take corrective measures for non-compliance or illegal acts. It may also share joint legal responsibility with oversea manufacturers on product quality and service-related actions. If China agent failed to perform these duties in accordance with detailed provisions listed, an added penalty would be imposed; if refused to correct, agent would even be prohibited in this role for several years. Foreign manufacturer may need to better assess their agent qualifications when make the choice, to ensure the selected party have sufficient regulatory knowledge and experience. China agent may also want to scrutinize their partnered manufacturers before starting a trip in the same boat.
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- Test report usage could be relaxed
Another eye-catching change is to ease the requirement for test report. The revision is proposing to abolish the current test reports from CFDA accredited test labs locally, and replace it with foreign manufacturer’s in-house test reports or with reports issued from any qualified test institutes. This change is suspected to trigger hot debates on several practical issues. Firstly, how to ensure self-testing report or report from 3rd party meet CFDA technical expectations, without receiving proper training and accreditation. The current certified test labs are all government-affiliated bodies and closely linked to CFDA’s policy-makers and regulatory activities. They also actively participate in national and industry standards drafting and play a key role on pre-reviewing the product technical requirement (PTR) as gate-keeper. When abolished their function, could new test institutes be qualified enough for a quick take over? Secondly, how to balance the workload between existing certified labs and new joiners, and optimize the equipment and knowledge already invested? Thirdly, the current testing is free of charge but with heavy delay. Would the introduction of new test institutes bring back the fee charges while speed up test delivery? Despite all the reservations, it would be no doubt a great bonus for foreign manufacturers to recognize their test lab if this proposal were approved.
- Clinical evidence out of China is accepted
Acceptance of clinical data out of China to avoid or reduce repeated trials is another strong merit for foreign manufacturer. This proposal is already grounded to implementation in 11th January 2018. An official guidance on how to design a clinical investigation is also released recently on 4th January 2018. Foreign manufacturer may use data from foreign clinical trials as clinical evaluation data for their China registration. These data could be pre-market data or post-market data, or data generated from equivalence products with proper authorization. It also encourages applicant to include China as part of multiple nation multiple-center study. Of course, clinical trials conducted abroad should adhere to the ethical principles set out in the Helsinki Declaration, and follow China GCP. Meanwhile, watch out the devils in details. Such as the performance of the device may be required to reach multiple observational endpoints, to justify race difference if applicable, and to consider clinical trial conditions. These conditions may include local medical facilities, researchers' abilities, differences in diagnosis and treatment principles, etc.
- Post-market supervision will be strengthened
Re-evaluation and follow-up procedures for marketed products will be further tightened up. The device which fails post-market re-evaluation, or fails adverse events reporting and/or corrective measures, or fails product performance and safety under changing circumstance, may lose their granted CFDA certificate. In contrast, CFDA starts to allow foreign devices into China without being marketed in its home country, to speed up innovative product approval process. What could be speculated is CFDA is aiming to touch lighter on pre-market requirements, while to tighten up post-market supervision in a more stringent way until the whole life cycle.
When people is wondering when this new proposal to 650 would be officially implemented, or if any further revision would be added when come to a final settlement, the clinical section already takes an early step to be released in the beginning of 2018. Other implementations may closely follow by. These revisions may impact various stakeholders on strategic thinking before and after entering China’s market. Legal manufacturers, China test houses, regulatory consultants, and clinical affairs staff may all need to review their product portfolio under a new stand.
Please read here my follow-up blog: Simplified Approval Process on the Horizon in China.
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