May 3 – With the view to support the development of the innovative medical device industry in China, China’s Food and Drug Administration (CFDA) released the “Special Review and Approval Process for Innovative Medical Devices (Draft) (hereinafter referred to as ‘Draft’)” on March 20, which increases the efficiency of the review and approval process for innovative medical devices. Detailed information can be found below.
To qualify for the special review and approval process, an applicant and its products must satisfy the following requirements:
The applicant shall own independent intellectual property rights to the medical device, meaning the applicant must be either the owner or the licensee of Chinese invention patents.
The primary functioning mechanism of the medical device shall be the first of its kind in China, and the device’s efficacy or safety profile shall be fundamentally improved as compared with other similar products.
The medical device shall have significant clinical application value.
The applicant shall have completed the initial R&D stage and have developed a basic prototype; the research process shall be authentic and under control, with the research data being complete and traceable.
Moreover, the applicant must be a legal entity in China (including wholly-foreign owned enterprises and Sino-foreign joint ventures), possess a valid medical device manufacturing license, and the relevant products must be manufactured in China
For applicants intending to engage in the special review and approval process, they shall file an application with the provincial food and drug administration (Provincial FDA). The Provincial FDA will then conduct a preliminary review and submit the application together with its preliminary opinions to the CFDA for final approval.
Once the application has been approved, the CFDA and the Provincial FDAs will give priority to such application in the entire approval process. In addition, both the CFDA and Provincial FDAs are required to communicate with and provide guidance to the applicant in a timely manner, including appointing a special government liaison for the applicant and establishing formal communication channels.
Apart from the efforts to improve the efficiency of the review and approval process for medical devices, the CFDA also intends to simplify the application materials required in the license re-registration process for medical devices.
In China, the medical device license is only valid for four years, and requires renewal prior to expiration. The regulation, named “Circular on Simplifying Application Materials Required for Medical Device License Re-registration (Draft) (hereinafter referred to as ‘Circular’)”, has offered a more streamlined re-registration process to help relieve medical device manufacturers from the tedious re-registration process.
According to the Circular, where there have been no material changes in the efficacy or safety profile of the medical device, the applicant no longer needs to provide the operation manual, product standards, and test reports.
Where there have been changes to the manufacturing address or the product’s model, specification, product standards, functional structure or components, the applicant only needs to provide technical documents relevant to the changes. The submission of the operation manual, product standards, and test reports is no longer required.
However, where there have been significant changes to the product structure and design, major material alterations, or other significant changes that may affect product safety and efficacy, a new product registration is still required.
Dezan Shira & Associates is a specialist foreign direct investment practice, providing corporate establishment, business advisory, tax advisory and compliance, accounting, payroll, due diligence and financial review services to multinationals investing in emerging Asia. Since its establishment in 1992, the firm has grown into one of Asia’s most versatile full-service consultancies with operational offices across China, Hong Kong, India, Singapore and Vietnam as well as liaison offices in Italy and the United States.
You can stay up to date with the latest business and investment trends across China by subscribing to Asia Briefing’s complimentary update service featuring news, commentary, guides, and multimedia resources.