The M22 intense pulsed light and laser equipment of Lumenis (Shanghai) Laser Technology Co Ltd, a company in the bonded area of the Shanghai Free Trade Zone, has received the city’s first "Import to Domestic Production" registration certificate for Class III medical devices issued by the National Medical Products Administration.
Lumenis, founded in 1966 and headquartered in Tel Aviv, Israel, is the only laser company in the world certified by the international organization for standardization and the largest medical laser equipment company globally.
In 2022, Lumenis (Shanghai) Laser Technology Co Ltd was established in the Waigaoqiao Bonded Area, primarily engaged in the production of Class III medical devices such as lasers and intense pulsed light. The certified M22 device will begin production in the second quarter, driving Shanghai to become a significant global production base for the company.
Zhai Qiying, senior president of Lumenis Asia-Pacific, said that with strong support from the Shanghai Food and Drug Administration and other departments, it took only six months from submitting the documents to obtaining the registration certificate. In the future, Lumenis will continue to increase investment in the bonded area.
Currently, the bonded area has gathered 848 biopharmaceutical companies. In 2023, the biopharmaceutical industry in the bonded area achieved a total operating income of 306 billion yuan (US$42.5 billion), a 7.3 percent increase from the previous year, accounting for about one-third of Shanghai's total.
At the same time, the import value of medical instruments and equipment reached 41.7 billion yuan, a 7.7 percent increase from the previous year, representing 43.0 percent of the total import value of similar goods in the country.
