I’ve spent the last 2 weeks traveling through the major cities in Australia discussing the regulatory framework in China and how companies can obtain approvals for their technologies (China ‘Market Ready’ Medtech Seminars). Through these events, I can see that the interest is still high for conquering the Chinese market, however the confusion on the regulatory pathway remains as strong as ever.
When you’re looking to take your products to market, you need to consider a number of factors as part of the product commercialization. These include distribution network, hospitals, intellectual property and that all-important regulatory approval.
Although China is very different to other jurisdictions, there are some similarities that need to be considered. I’ve outlined a basic framework for getting approvals in China below.
To begin down the road of product registration, you need to understand the classification of your device. Once you as the manufacturers understand this, you’ll have a clearer idea as to pathway forward and the necessary hurdles you’ll need to navigate.
If your device is classified as Class I, it’s considered a low risk device. In China, there is a publication/catalogue of Class I devices which is regularly updated to include more products. The Catalogue is very specific . If your product is in the catalogue, you can proceed forward with a Class I application. The Class I is a notification only and will be automatically included if all the necessary information is included in your documentation.
If you’ve no match to a device in the current classification catalogue, you need to file a classification petition, which will be evaluated and determine the appropriate risk class of your device – which will be included in the next update. If Class I, then it will be available in the Class I catalogue.
We then move onto the more challenging areas of higher risk devices. If your device is a Class II or III, you have a few pathways to take your product through approval. These are very depend on existing technologies in the market.
First and foremost, your device must already have been approved in its country of origin. If it’s not, then you are unable to proceed with your application – CFDA simply will not accept applications for imported devices which lack home country approval.
So you want to apply. First step is Type Testing.
Type Testing is, in simple terms, testing of a product ina CFDA approved test lab to ensure it meets Chinese requirements. In most cases this means compliance with national standards (specific product standards and horizontal standards such as biocompatibility and electrical safety) which are in turn largely based on international standards. A large number of products have a predefined set of protocols for the testing to be performed against, but in the case where there is guidance, initial meetings with the CFDA/Type Testing centres may be required to determine the minimum requirements for the testing. Only once you’ve gained approval from the type test centre will you proceed with your registration activities. Be sure that you have resources available to support the type testing. This can be a lengthy process, specifically in high risk innovative technologies. It may involve members of the manufacturing team being on site at the type test centre for protracted periods.
Once you’ve gained your type test certificate and report , you can move forward with preparing your registrations/application (assuming you don’t need a clinical trial – which we’ll touch on a little later). For Class II and III, the CFDA have (similar to Class I) catalogues of devices/products listed which are exempt from clinical trial (Clinical Trial Exemption List). There are currently around 700 devices listed for Class II as of the last publication in October 2016, and 160 for Class III devices. If the manufacturer can justify their equivalency to a product within the exemption list, then they may avoid a Clinical Trial. The justification is provided along with your application, so it is critical to ensure this information is accurate.
If your device is not on the exemption list, you will have an mountain to climb in proving equivalency to an existing product already approved in China. In the event you have your own product approved, and the similarities of the products are close enough, you may be able to use this as your predicate device. As the product owner, this is more straightforward.
If you don’t have product already registered in China, you can attempt to justify the predicate device that is not yours ie a competitors product. Be warned, this process is very difficult. The specific details required as part of your data to prove equivalency includes such material as safety evaluation reports and primary testing data, which generally are not available to competitors. Information required for a Class II predicate, although not as specific as Class III, can also be difficult to obtain.
The equivalency data is presented by way of a Clinical Evaluation Report at the time of application. Similar to the earlier comment, you want to be sure that your dossier and supporting evidence is complete and accurate prior to submission. This can save you substantial time once your application is submitted. Like most regulators, if the data is not clear it can result in several rounds of communications and possibly even rejection.
If you don’t have a product listed in the exemption list, and cannot prove that your product is similar to a device or technology already marketed, you have no choice but to apply for your clinical trial. This process can increase costs to market up to tenfold. It’s critical that you’ve reviewed all avenues prior to this, but if there are no other options, be sure you have a solid CRO who can assist. Most importantly, be sure they have substantial staff on the ground who can be at the hospitals during the trial, but also have access to some of the larger hospitals. This enables you complete transparency during the trial and the development of the supporting data after the trial is complete and ready for an application.
Finally – registration filing
Assuming we’ve now gotten through the above, you’re ready to submit! I cannot say enough, be sure that all the data is accurate and complete and your partner or regulatory agent is across your products and the processes. This will hopefully make the process more streamlined.
Now that you’re approved, you’ll move onto post market requirements such as recalls and adverse events which is a different blog!
Need some guidance with your China registrations or strategy? Be sure to contact us. Let us introduce you to one of our very capable, bilingual regulatory experts in both our Sydney office and in Beijing for an obligation free review of your needs. Call +61 2 9906 2984 or email email@example.com