High-frequency hyperthermia cancer treatment device ‘REMISSION 1℃’ opens export path to Malaysia

AdipoLABs obtains Malaysian MDA certification... being a ‘gas pedal’ to target the ASEAN medical market

▲ Malaysian MDA certificate (left) and AdipoLABs’ executives and staff visiting a medical institution in Malaysia.

【Whosaeng】  AdipoLABs Co., Ltd. (CEO Han Sung-ho), which is leading the global high-frequency hyperthermia cancer treatment device market with 'REMISSION 1℃' developed by pure domestic techonology, recently obtained MDA certification from the Malaysian Ministry of Health. Exports to Malaysia are in full swing starting this year.

AdipoLABs recently announced that ‘REMISSION 1℃’ has obtained Malaysian MDA certification.

However, it took a lot of time and effort for AdipoLABs to receive Malaysian MDA certification. The Malaysian certification process is very strict, but after two years of persistent tries, the company passed all procedures and verifications finally obtaining MDA approval in the Hyperthermia category.

Malaysia MDA, which stands for Medical Device Authority, is a domestic approval issued by the Malaysian Ministry of Health for medical devices.

In order to receive Malaysian MDA certification, companies with products must pass strict procedures and thorough verification, and either European CE or US Food and Drug Administration (FDA) certification is required as well.

In addition, even with international certification, the organization is making every effort to ensure verification and safety. In particular, MDA approval itself is mutually recognized among ASEAN countries, so it is expected that the ripple effect of MDA certification will be very large.

Regarding obtaining this certification, CEO Han Sung-ho said, “We have been working vigorously to launch ‘REMISSION 1℃’ in the Malaysian market since October 2018. For this, we have been preparing for European CE certification from the second half of the same year and received European CE certification in August of last year. We worked hard for the Malaysian MDA certification, and finally obtained it.”

With the acquisition of this MDA certification, the demand for ‘REMISSION 1℃’, a hyperthemia cancer treatment device, is expected to increase significantly not only in Malaysian hospitals and clinics but also in various cancer centers.

▲ MOU signed between AdipoLABs Malaysia (CEO Moses Balagopal, Isaac Joseph) and BubblesO2 company.

In addition, AdipoLABs is actively working to deliver hope to cancer patients in Malaysia.

AdipoLABs recently signed a contract with Malaysian oxygen water sales company (BubblesO2) to jointly use REMISSION 1℃ and oxygen water at medical centers (Medical SPA & Wellness Centre's) for the purpose of cancer treatment for general cancer patients from March.

Even in a difficult situation in the international economy due to the COVID-19 pandemic, AdipoLABs' Hyperthermia cancer treatment device, REMISSION 1℃, is receiving great reviews.

CEO Han Sung-ho said, “We expect the hyperthermia cancer treatment device developed with our technology to make a significant contribution to exports in 2021,” and added, “The achievements made so far for export of REMISSION 1℃ are becoming visible one by one. “We will accelerate the increase in exports.”

He also emphasized, “AdipoLABs will make even more efforts in 2021 with the mission of taking responsibility for the health of all global citizens.”

Meanwhile, AdipoLABs' 'REMISSION 1℃' is a professional medical device that obtained manufacturing permission from the Ministry of Food and Drug Safety in 2015 and received Halal certification, US FDA registration, ISO13485 certification, Shariah certification, and RoHS certification in 2018. .

In particular, it is being used in over 80 medical institutions across the country, including Seoul St. Mary's Hospital of the Catholic University of Korea, and is receiving attention from the medical community as it is showing many clinical effects when administered to patients.

‘REMISSION 1℃’ is a high-frequency hyperthermia cancer treatment device that treats cancer and relieves pain by raising body temperature above 40℃ and improving blood circulation and immunity through deep heat. Through this, they participated in the ‘Middle East-Asia Business Expo 2018’ held in October 2018 and the ‘35th International Medical Equipment and Hospital Equipment Exhibition (KIMES 2019)’ held in March 2019. It has attracted the attention of medical officials at home and abroad.

source: [후생신보] 고주파 온열암치료기 ‘리미션1℃’, 말레이시아 수출 길 `활짝` (whosaeng.com)