Ten years of clarifying rules and increasing transparency

The past decade has seen key changes in China’s medical device regulatory systems. Starting with new baseline legislation, a series of legal details has built a comprehensive regulatory framework. Adding increased transparency and a modern IT system for submissions and market surveillance has resulted in a reliable and clear legal structure. The NMPA website provides the essence of major regulations and announcements in English.

Following the publication of the 2014 decree and the 2019 revision of the fundamental Regulation of Supervision and Administration of Medical Devices, various layers of legal and regulatory expectations have been built on top of the key framework; see our earlier blog on the regulatory structure currently in place. China’s authority recently published a draft version of the Medical Device Management Law, which is being put forward for public consultation. It is expected that medical device management will be further reformed and improved. Whereas regular interaction with the dossier reviewer was historically a key element of the conformity assessment, the new system has become so clear that regular debates on joint interpretations are no longer required. Upon submission, typically in a timely fashion, a list of key deficiencies is provided in the acceptance review phase, which can be cleared in a low number of close-out rounds.

In some cases, it is still helpful to provide insights to the reviewer in a face-to-face or electronic meeting. For example, this is useful for complex products, cases where new materials are being applied, or in cases of core innovation. The system is set up to allow electronic requests for such meetings. Once everything is in place, the full dossier submission is done electronically.

Overall, the increased clarity has led to generally reduced and more reliable timelines for the submission process. Where, in the distant past, this could be influenced by regular visits and communications, the current practice results in a market access review of 1 to 3 years, depending on the speed of close-out of the deficiencies. This is where a manufacturer may influence their timings: good preparation, accurately understanding what the reviewer is looking for (for example, providing exactly what is asked), and rapid follow-up on deficiencies. Take EMC testing, for example. Certain tests in the EU or USA accept rationales for testing in smaller facilities than the standard actually indicates, as larger EMC testing rooms are not always available. However, the test lab accreditation system works differently in China. Also, due to China having modified EMC IEC standards for localization, gaps exist in the testing conditions or methods. The rationales created for other countries are typically not accepted in China, so re-testing needs to be organized. The same happens in electrical safety testing, where specific tests are best performed in a Chinese reference lab. Once decisions have been made to ensure compliance, the typical follow-up process runs much smoother. Trying to get exemptions or trying to rationalize deviations may take more effort or lead to longer processing times than complying directly with the requirements.

Another improvement we have seen in the system is post-market surveillance. Audits are being performed on selected manufacturers; their production sites, and sometimes the local offices or the office of the China Agent, are more regularly inspected based on risk levels. While Europe and the USA are used to sending in one or two auditors from the agency or a notified body, the Chinese auditor team typically comes with a larger group. In a very structured way, the team works through the various requirements, and clear regulatory expectations also support a predictable process.

As a manufacturer, the first-time submission into China might be daunting, as many things are slightly different from Western jurisdictions. For that, support from your local team or the China Agent you work with will help prepare for a smooth process. As another example, this does not mean simply translating your US or EU submission. Many elements are similar but have to be restructured or rewritten based on China-specific guidance documents. For example, your clinical evidence: in case this is based on your EU or US standard clinical evaluation, you will need to perform a gap assessment with China GCP and review whether the study design meets the China product-specific clinical guidance requirements if the evidence is based on the clinical trial route. Or, if the equivalence route is applied, comparing and contrasting your device with a competitor’s product that is already available on the Chinese market.

If you’re up to the challenge of bringing your product to the market in China, I’m sure you’ll connect!