The medical device industry in China is highly-regulated and China adopts a “pre-market” recordation or approval system for medical devices. Before any medical device can be manufactured, imported, distributed, or sold in China, one must first go through certain filing or registration procedures with the National Medical Products Administration of the PRC (the NMPA). At the same time, gaining access to China’s medical device market is strategic for local and foreign medical device manufacturers alike.
As set forth in the Regulations on Supervision and Administration of Medical Devices, a “medical device” is an instrument, equipment, apparatus, in-vitro diagnostic reagent, or calibrator, or any similar material or article, including medical software, which is used directly or indirectly on the human body. There are three general classifications for medical devices in China:
A Class I medical device requires only a “filing” with the provincial or municipal level NMPA (if it is locally manufactured) or with the central level NMPA (if it is imported). In either case, the filing process is relatively straightforward and would require the submission of certain technical documents, including the technical requirements and instruction for use to the NMPA for its administrative review. This review generally takes the NMPA one to five business days to complete.
A Class II or Class III medical device must be “registered” with the central-level NMPA and a medical device registration certificate (with a five-year term) must be obtained before it can be manufactured or distributed in China. One exception to this is that, with China’s move to market opening, as of 2 April 2018, medical institutions in Lecheng International Medical Tourism Pilot Zone located at Bo’ao Town of the Hainan Province (the Hainan Pilot Zone), may apply, on the grounds of emergency, with Hainan provincial-level NMPA to import foreign-manufactured Class II or Class III medical devices that are not yet “registered” with central-level NMPA.
The central-level NMPA registration process for a Class II or Class III medical device, whether locally or foreign-manufactured, will encompass the following:
The above process can take 18 to 24 months to complete assuming that a desktop clinical evaluation suffices and no clinical trials are required.
A foreign manufacturer would have to make submission through its China subsidiary, China branch, or an agent in China as appointed by the foreign manufacturer. All information submitted to the NMPA or its authorized testing center must have a Chinese language counterpart.
In December 2018, the Food & Drug Administration of the United States (the U.S. FDA) published a framework for Real World Evidence Program, where the U.S. FDA explained that:
Real world data is essentially data derived from a number of sources that are associated with outcomes from patients in real-world settings, such as patient surveys, electronic health records, claims and billing information, etc., as opposed to the traditional clinical trials.
The discussion of real-world data and real-world evidence has attracted attention in China for a number of years and a number of government initiatives have followed.
In April 2019, the NMPA launched a research program on using real-world data in medical device clinical evaluations. In June 2019, the NMPA commissioned the real-world data pilot program in the Hainan Pilot Zone (the Hainan Pilot Program). Three out of ten products participating in the Hainan Pilot Program received approval in November 2019 to commence real-world studies on the data collected from the Hainan Pilot Zone for clinical evaluation purpose. A task force comprising experts from the NMPA and the Hainan government has been providing guidance to the medical device manufacturers of these three products.
Further, as announced by the NMPA in September 2019, a branch office of the Center for Medical Device Evaluation of the NMPA will also be established in the Hainan Pilot Zone to review the medical device registration applications as one of the facilitation measures to the Hainan Pilot Program.
On 13 December 2019, the NMPA circulated the Guideline on Use of Real-world Data in Medical Device Clinical Evaluation (Draft) (the RWD Draft). Under the RWD Draft:
The RWD Draft sets out a non-exhaustive list of situations where the real-world data can be used for clinical evaluation in China:
On 26 March 2020, through the use of real-world data and pursuant to the Hainan Pilot Program, Allergan’s XEN Glaucoma Treatment System became the first foreign-manufactured medical device registered in China. It took only five months from the real-world studies that started in November 2019 to the final registration approval of the NMPA. If this had followed the normal route of clinical trial, the registration process could have taken 3-5 years to complete. NMPA has separately indicated that several products are currently being reviewed for registration under the Hainan Pilot Program.
The RWD Draft becoming law will provide alternatives to the current clinical evaluation regime for medical devices in China. This should providing significant time and cost saving in registering Class II and Class III medical devices.
The RWD Draft and the NMPA initiatives are already providing a new path for medical device registration in China. For example, a foreign manufacturer may join the existing Hainan Pilot Program, or take advantage of the RWD Draft once it becomes law to use real world data for clinical evaluation and waiving any clinical trial requirements.
China’s legal landscape for medical devices continues to evolve rapidly to respond to the growing needs of its robust markets. Stakeholders with an interest in these markets, including our clients, have been early-movers in obtaining counselling on compliance and regulatory matters, as well as program implementation.