Sharing at the launching ceremony of “Personalized 3D printed Peek skull graft” on August 2, Dr. Nguyen Minh Loi, Director of the Department of Infrastructure and Medical Equipment ( Ministry of Health ), said that after a period of clinical trials, the Ministry of Health has licensed the circulation of “Skull graft made from Peek material”. This is the first domestic skull graft licensed by the Ministry of Health, opening up a new treatment direction for the medical transplant industry with advanced technology, personalized to each patient, immediate grafting without waiting, and much lower cost than imported skull grafts.
According to Mr. Loi, if in the early days of 2020-2021, there were about 17,000 medical equipment files of type C, D that had not been licensed, by July 2025, the Ministry of Health had processed 97%, and about 1,000 files had been read and assessed but had not been licensed because they did not meet the requirements. "We give special priority to domestically produced products that were licensed first," said Mr. Loi.
According to the Director of the Department of Infrastructure and Medical Equipment, implementing the spirit of Resolution 57 and Resolution 68, the Ministry of Health is researching, building and perfecting policies to develop the domestic medical market. At the same time, the Ministry of Health is also working with the Health Insurance Agency to bring supplies such as Peek skull grafts to be partially paid for by Health Insurance soon, to support people to soon access good quality products at much lower prices than imported products.
Mr. Loi also hopes that in the coming time, many domestic manufacturing enterprises will contribute ideas to the Ministry of Health to perfect institutions and policies, helping the domestic medical equipment manufacturing market develop, bringing cheaper prices and applying them immediately to patient treatment.
“Ngoc Bao Medical Joint Stock Company spent 5 years waiting for the skull graft to be assessed and licensed. If in the period of 2021-2022, it took 3-4 years for the application to be licensed, in the past time, the Ministry of Health has had many solutions to shorten the time to assess the application for a license to circulate medical devices of type C and D. Currently, if the application meets all the conditions, it will only take 2 months to be licensed," Mr. Loi emphasized.
The Director of the Department of Infrastructure and Medical Equipment also affirmed that the supply of medical equipment to the market is not lacking, some hospitals are lacking because the procurement procedures have not met the requirements.
Previously, Ngoc Bao Medical Joint Stock Company has researched and clinically tested skull grafts for patients. The first case was transplanted 7 years ago at Hai Duong General Hospital; the latest case just had a skull graft last week at Viet Duc Hospital, both with good results.
To date, nearly 200 patients have been successfully transplanted from this skull graft at hospitals: Viet Duc, 108 Military Central Hospital, Xanh Pon, Thanh Nhan, Quang Ninh General Hospital, Hai Duong General Hospital...
The advantage of the graft is that the patient does not need to go to the manufacturing facility, but only needs to send data on the bone defect area. After a maximum of 2 weeks, they will receive a device that fits the defect area that needs to be restored. Furthermore, because it is a personalized device, the surgeon can operate it easily, shortening the patient's surgery time and hospital stay.
The graft has high biocompatibility, is easy to assemble, restores the exact shape of the skull, has no size limit and is suitable for all skull areas - including difficult locations such as complex skull and face areas.
According to Mr. Loi, domestically produced skull grafts cost about 1,000 to 3,000 USD, applied directly to each specific patient, much cheaper than foreign products. If partially covered by health insurance, the opportunity for patients to access the transplant will increase significantly.
Source: https://cand.com.vn/y-te/de-xuat-bhyt-chi-tra-cho-benh-nhan-bi-tai-nan-u-nao-khi-ghep-hop-so-i776831/
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