Pilot policy to boost output of medical devices

Automated external defibrillator (AED) machines tailor made for young patients produced by Suzhou Jousing Medical Technology Co Ltd are expected to gain national approval by the end of the year－an accomplishment which would not be possible without the experimental policy introduced by the China (Jiangsu) Pilot Free Trade Zone Suzhou Area, said the company's chairman Sun Jianyan.

Sun said the company launched research and development into the AED machines for children in October. Electrode pads with less resistance imported from Italy are key components.

As such products are not yet registered in China, they cannot be directly imported into the country. Therefore, it used to take at least three months for Jousing to import the electrode pads in indirect, inefficient ways.

However, the Suzhou FTZ Area implemented a hierarchical management of unregistered medical devices imported for R&D (testing) purposes in September last year. It was one of the first seven experimental policies carried out immediately after the FTZ Area was officially unveiled.

According to the new policy, scientific institutions and companies located in the Suzhou FTZ Area can import unregistered medical devices or parts for R&D purposes based on general trade regulations.

Such imported medical devices are classified as essential so that the local administrative body can carry out management accordingly. Customs clearance procedures will thus be smoother as regulations are more detailed. As soon as the new policy was announced, Jousing became one of the first companies to make application in October. The approval was granted one month later, which was much faster than expected.

With the first 20 electrode pads arriving at the beginning of the year, Jousing immediately began R&D into AEDs tailor made for children. With registration materials submitted in April, the new product is expected to be approved by the end of the year. Based on the new policy, Jousing will conduct more R&D into AEDs used for more scenarios, such as the portable machines used for tourist groups or those used in extreme weather conditions.

"Companies all applaud such regulations, which save time and costs. The entire medical device industry in the Suzhou FTZ Area will thus be boosted," Sun said.

To date, six companies in the Suzhou FTZ Area have imported 30 batches of unregistered medical devices in accordance with the new policy. The policy was recognized in early August as the "Best Practice Case" of the State Council's pilot program of deepening innovation development of the services trade.