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How to achieve CFDA approval for your biomedical devices?
Gaining CFDA certification for next-generation biomedical devices resembles the processes for approvals from other countries. It’s not as difficult as it sounds.
, Ingolf Reischel
With more than 1.4 billion people interested in staying healthy, biomedical device manufacturers have golden opportunities in the Chinese market. Hospitals, healthcare organizations and biomedical research laboratories are growing and demanding the same cutting-edge technologies that are found in other countries.
Like most large nations, China has a regulatory agency that must approve all biomedical devices sold within its borders. Over the years, the certification process for products destined for the Chinese market has gained a certain aura of difficulty. However, the reality is that Chinese medical device approval parallels the regulatory pathways in other developed countries, and the process is more straightforward than ever.
Inside the CFDA
China’s agency in charge of biomedical health and safety was known as the China Food and Drug Administration (CFDA) until 2018, when a governmental reorganization effort restructured it as the National Medical Products Administration (NMPA). Nevertheless, CFDA is still a widely used acronym for the country’s certifying authority for biomedical products and medical devices.
Just like the U.S. Food and Drug Administration, the CFDA/NMPA divides medical devices into three broad categories and publishes a catalog listing of the devices and their requirements for approval.
Class I
- Low-risk devices.
- No clinical trials are necessary to assess safety, just routine administration.
- Examples: tongue depressors, cameras, adhesive bandages.
Class II
- Medium-risk devices.
- Product testing is required to ensure safety and effectiveness.
- Examples: surgical tools, endoscopes, catheters.
Class III
- High-risk devices.
- Product testing is required.
Clinical trials are always required, unless the medical device has a proven record of safety and effectiveness.
For equipment manufactured in other countries, the CFDA will review the results of clinical trials in either China or the other jurisdictions or both. - Examples: body implants, medical devices for life support or sustenance, cardiac pacemakers and implantable drug-infusion pumps. Devices that could potentially harm the patient.
The U.S. FDA puts microscopes, cameras, and other bioimaging system components in either Class I or Class II, so the CFDA most likely classifies them similarly.
Each new product submitted for CFDA/NMPA approval must have a dossier of specific information and registration forms filled out in Simplified Chinese. Even manufacturers of Class I devices must submit a risk analysis document, technical specifications, a product testing report, a clinical evaluation report, and information about the manufacturing process.
The CFDA/NMPA begins the review process for a new medical device once it receives all application materials from the medical device manufacturer. Once granted, the certification lasts for five years. Renewal applications should be submitted at least six months in advance of the expiration date of the original approval.
What does it mean for biomedical device manufacturers?
When developing complex biomedical devices and submitting them to regulatory agencies, it always helps to have experienced partners by your side. For digital light microscopy and other advanced diagnostic bioimaging solutions, Jenoptik can support you with the required documentation in the STED (Summary Technical Documentation) format to fulfill the CFDA needs for examination and testing purposes.
A product development schedule should not only include the planning work for the design, engineering, and integration but also the time needed for the regulatory approval process. This is another arena where working with Jenoptik as a certified OEM supplier in regards to important key technologies such as components, modules or systems can bring dividends. By providing the relevant background information that the CFDA requires, Jenoptik can help to speed up the Chinese approval process that consequently helps you to reduce your time-to-market.
The CFDA certification applies only to the end product, not to the individual components. But having the subsystem or component certification in place greatly simplifies Chinese approval of the end product. For Class I products, the CFDA (or NMPA) generally accepts the results of testing in other countries. For Class II and Class III products, China will ask for product samples to do its own testing.
Microscopy plays a critical role in the biomedical sciences, from biopsy and surgical imaging, molecular diagnostics to live cell imaging systems for making new discoveries in pharmaceutical targets and biomarkers. China is prioritizing approvals for the most innovative medical devices, and bioimaging is bound to be one of the key technologies for the Chinese market over the coming decade. Working with Jenoptik as a trusted supplier of bioimaging subsystems can boost your chances of attaining success in this eager marketplace.
If you would like to learn how Jenoptik can speed up your biomedical device approval in China, then contact us.
About Ingolf Reischel
Especially in the field of medical technology, better and faster prevention, diagnosis and treatment of diseases are becoming increasingly important. As head of the market segment healthcare & life science, Ingolf Reischel technologically accompanies these topics in the division Light & Optics. A particular focus is on diagnostic, dental, ophthalmological and biotechnological applications. As an engineer in technology electronics and industry expert, he knows the interaction of optics, electronics and mechanics as well as the requirements for approval and quality assurance of medical technology systems in an international context.
