On March 31, 2014, China’s State Council published the amended Administrative Regulation on Medical Devices, which will become effective on June 1, 2014. The Regulation, since becoming effective in 2000, has been the cornerstone of China’s medical device regulatory system. The amended Regulation contains important revisions that will significantly impact the medical device industry in China.
- Expanded Definition
The amended Regulation expands the definition of medical devices to include new categories of products: “instrument, apparatus, appliance, in vitro reagent and calibrator, material and other similar or related article, including the necessary software, which are intended … (4) for the purpose of life support or maintenance … or (6) to collect information for diagnosis or treatment utilizing human sample testing.”
- Product Registration
The amended Regulation makes some significant changes to the current product registration regime for medical devices. Class I devices, including imported products, are no longer subject to registration, but rather a filing with the China Food and Drug Administration (CFDA) or its local counterparts; Class II and Class III devices continue to be subject to the same registration requirements.
For newly-developed medical device products for which no existing classification is available, applicants may either register the products following the regulatory pathway for Class III devices or apply for classification by CFDA.
A more significant change is that local manufacturers may start product registration with CFDA before their manufacturing facilities are ready; a measure intended to ease the financial burden of companies in their initial investments for device manufacturing.
- Clinical Trials
Under the amended Regulation, clinical trials are not required for registration of Class I devices. Certain Class II and Class III devices may be exempted from clinical trials, based on a product catalogue to be developed by CFDA, if they are mature in terms of working mechanism, design and manufacturing process, and their safety and efficacy can be verified through non-clinical evaluation or with data from existing clinical trials or clinical use of the same type of device products.
In the meantime, the amended Regulation imposes a new Clinical Trial Approval (CTA) requirement on certain high-risk Class III devices. Class III devices falling into a CFDA-developed catalogue will be subject to these requirements.
The amended Regulation does not establish the market authorization holder (MAH) system the industry has been calling for. It continues to impose a Medical Device Production License (MDPL) requirement on local manufacturers of Class II and Class III device.
Before applying for a MDPL, companies should first obtain product registration for devices they will manufacture.
The amended Regulation eliminates the Medical Device Distribution License (MDDL) requirement for Class II device products in China. Going forward, only distribution of Class III products will require a MDDL.
- Medical Institution Use
The amended Regulation requires medical institutions to keep adequate records of device products they use, and to properly record information relating to implant and other interventional devices to ensure traceability. Also for the first time, the amended Regulation explicitly allows transfer of used medical devices between medical institutions, to the extent the products remain “safe and effective.”
Following the issuance of the new Regulation, CFDA has released a number of draft implementing rules on product registration, manufacturing, distribution and clinical studies. Companies operating in China, either directly or through Chinese subsidiaries or third party distributors, should familiarize themselves with this regulatory overhaul.