Q1: What are some of the main trends concerning product registration in China?
EC: In 2013, I have seen the market continue to increase at a high rate. The Chinese market is massive and willing to spend a lot on new medical technologies. There is especially a demand for foreign devices representing advanced technologies, even though these devices are typically more costly than their generic or more traditional counterparts.
Medical device imports into China have continued to increase and we saw a 20% growth in 2013 in that area alone, including devices like endoscopes, dental materials, contact lenses, and ultrasonic inspection equipment. Exports also grew 9% in the same year. I think that there are many opportunities for manufacturers here. However, to take advantage of these opportunities, registration and pre-market approval must first be obtained for the device.
Q2: Last year, the State Food and Drug Administration (SFDA) was restructured as the Chinese Food and Drug Administration (CFDA) and some important changes in the regulations for different products were introduced. How do these changes affect medical device manufacturers?
EC: Following problems with the regulation of food products in China in the last few years, the SFDA was reorganized to include other offices and departments under one, new general administration. The SFDA oversaw the regulation of medical devices, drugs, and cosmetics but the new CFDA also regulates food and other products under one body.
For medical devices, the main changes are regarding the re-registration of products that have come into effect on Jan. 1st 2014. Previously, re-registration of medical devices required test reports in China and other costly and time-consuming processes. As of Jan. 1st 2014, if these documents have not changed since submitted during the initial registration, they are not required for license renewal. In addition, if there has been a small change to the device documentation, you are now permitted to submit only that part instead of resubmitting the whole dossier. This will save manufacturers a lot of time and money in testing fees, etc.
Q3: Can MedTech manufacturers expect more changes down the road from the CFDA following those instituted in related industries, like food and pharmaceuticals?
EC: Every year, Chinese standards are changing and improving to become equal to ISO/IEC. Eventually, I expect that Chinese regulations will be the same as ISO/IEC standards. In some ways, this trend indicates a new vision for the Chinese authorities.
I hope that this means that the CFDA will start recognizing more IEC-certified technical documentation so that manufacturers do not have to repeat testing in China as often, or that Chinese labs will have the option to support ISO/IEC-approved testing instead of publishing their own reports in every case.
Q4: What would you say are some of the greatest challenges to successful registration?
EC: I usually deal with registration for Class III products and some of the greatest challenges are with electrical equipment. Non-electrical equipment must only pass bio-compatibility tests, but electrical equipment, especially if manufactured overseas, requires many technical documents. There are also new requirements for software that can be quite challenging.
There are also many challenges associated with registering new medical devices. The first company to do this can meet many barriers in the registration process. After the first successful registration, other companies will find it much easier. However, if you’re the first in the market, you have a huge advantage.
Q5: What is the best advantage manufacturers can have when conducting registration in China?
EC: It usually takes around six months to register Class I devices and 12-18 months for Class II or Class III products. For foreign manufacturers, it is important to have a local partner and develop a good relationship with the local authorities in a particular region. In an area like Shanghai, the process can be very quick and efficient if you meet the requirements. In other areas, it can take longer. There are different levels of efficiencies in different regions and provinces.
Also, if a device does not have a recognized certification such as a CE Mark or USA FDA approval, there can be difficulties in the process and Chinese authorities may request additional testing. Even though the CFDA (previously the SFDA) has not charged any fees for registration since 2005, testing fees are required. A clinical trial, if necessary, can be quite costly.
For manufacturers with factories in China, I recommend that they obtain GMP certification before they get their license.