Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Framework and Key Steps of Medical Device Registration in China under Current and Revised Regulations on Supervision and Management of Medical Devices ***

Dr. Xia Dong (Abschlußjahr: 2021)

Summary
Language: English
China's medical device industry has maintained a double-digit growth for over 10 years and expected to enter a “golden decade” of rapid development in the following 10 years due to its market size and aging population. Even under the pandemic situation, China's medical device industry still maintained a positive trend and the market scale continued to expand with the expectation to exceed 140 billion U.S. dollars by 2022. While the most Chinese domestic medical device manufacturers are found in low-end conventional product market, the medium and high-end market still offer great opportunities for imported medical devices.
One of the greatest challenges for foreign medical device companies to enter Chinese medical device market is its complicated, stringent and ever-changing regulatory requirements. Although many improvements have been made in recent years, e.g. accepting the oversea clinical data, allowance the product testing by third-party and more transparent during technical review procedure, obtaining market access to China’s medical device market still takes at least 16 months for a Class II medical devices.
Under the urge demand for optimizing the medical device regulatory system, the State Council of China finally introduced the revised “Regulations on Supervision and Management of Medical Devices” (the State Council Order No. 739) after almost three years’ discussion. The most registration procedure relevant amendments include acceptance of self-product testing report, exemption of clinical evaluation for eligible medical devices and change clinical trial approval from express permission to implied permission, etc. Despite the purpose of the revision is to simplify and assist the medical device companies to bring more high-quality product into Chinese market, the frequent policy reforming makes it very difficult for the applicant to follow, not to mention that the short time period from announcement to implementation. As such, successful regulatory approval requires a deep understanding of the regulations, procedures, guidelines, technical standards and new policy trend, as well as an appropriate regulatory strategy.
This thesis introduces the whole picture of medical device regulation system in China under current regulations, as well as the revised regulations, which will come into force on 01 Jun 2021. Based on the understanding of the whole regulatory framework in China, the key steps in medical device registration application procedure are further discussed in details with the intention of deepening the understanding and assisting the related regulatory strategy decision making.
Product Technical Requirement (PTR) and the product testing based on PTR play very important roles in the whole life-cycle of medical device products in China. The PTR has to be drafted referring the current Chinese national and industry standards and shall be updated when the new version of Chinese national and industry standards is available. Although most of the Chinese national and industry standards are adopted or translated from international standards, the backlogs of adopt of the latest international standards, language barrier and possible discrepancies make drafting PTR the most challenge work. The thesis introduces the PTR from legal basis, impact on the whole life-cycle of the products, Chinese standards system, related technical guidelines and the useful publicly accessible databases. A starting point is expected to be provided to the reader for PTR, although it is highly recommended to assign the PTR drafting to qualified local regulatory experts.
The product testing is another challengeable task before submitting the application. This thesis discusses the current situation of product testing in China and the selection recommendation of the testing paths and institutions. The revised regulations State Council Order No. 739 cancelled the obligation of testing report issued by national testing institutions, so that a self-testing report is accepted for medical device registration from 01 Jun 2021. For the applicant who does not have the testing capacities, a commissioned third-party testing provider is an alternative choice.
Clinical evaluation has long been a focus of attention for all parties, as it is the most important, time and cost consuming step of the whole registration procedure. The current three possible paths for completing clinical evaluation are introduced and compared. As the implementation of the revised regulations, the clinical evaluation may be entirely exempted for the eligible medical devices. While the supporting provisions for exempting clinical evaluation and the list of medical devices exempted from clinical evaluation are expected to be announced by the NMPA in the near future. Although the revise regulations are not as open as expected, these new policies definitely convey the positive signal on accelerating the medical device registration in China for foreign medical device manufacturers.
The foreign medical device manufacturers must find their best accessing point under the context of reform of regulatory landscape and the intensive market competition. Based on the thoroughly understanding of the regulatory system, tracking the policy updates, re-examining the business models and invest more in innovative technologies will provide for sure of great opportunities to catch up the future growth of the Chinese medical device market.
Pages: 70
Annexes: 2, Pages: 6