Independent Survey Conducted on Awareness of Public Certifications for Overseas Laser Equipment | Verifying Recognition of FDA and MDSAP Certifications for ICONIC PICO3 PRO and Others
MEDLAC Instrument and Consulting Co., Ltd. conducted an independent survey on the awareness of Japanese doctors regarding public certifications (such as FDA and MDSAP) for overseas laser equipment. The survey aimed to clarify the actual state of information comprehension among medical professionals and verify the recognition of certifications for devices like ICONIC PICO3 PRO.
📋 Article Processing Timeline
- 📰 Published: April 25, 2026 at 03:00
- 🔍 Collected: April 24, 2026 at 18:31
- 🤖 AI Analyzed: April 24, 2026 at 22:36 (4h 4m after Collected)
※This release provides an overview of the results of a survey independently conducted by our company.
※This is not intended to recommend specific products, procedures, treatments, adoption decisions, or usage.
※The results of this survey are based on information independently collected and analyzed by our company and do not guarantee specific efficacy, effectiveness, or safety in Japan.
※Individual adoption and usage decisions should be made by yourself after confirming the latest public information, relevant laws and regulations, legitimate materials from equipment providers, and other necessary information.
MEDLAC Instrument and Consulting Co., Ltd. (Headquarters: Fukuoka City, Fukuoka Prefecture; Representative Director: Hideki Ogawa) has conducted an independent survey to understand the awareness of domestic doctors regarding the acquisition status of public certifications for overseas laser equipment and their actual grasp of information, and is now publishing the results.
Background of the Survey
Among overseas medical devices, some have acquired international public certifications such as the U.S. FDA (U.S. Food and Drug Administration) and MDSAP (Medical Device Single Audit Program).
However, the extent to which domestic medical professionals understand the existence and meaning of these certifications has not been sufficiently investigated or organized until now.
As a provider of information on overseas medical devices, our company conducted a survey to understand objective information regarding manufacturers' quality control systems and the awareness of domestic doctors regarding this information.
Overview of Survey Results
This survey verified and analyzed the following three items:
① Survey on awareness of public certifications (FDA, MDSAP, etc.) for overseas laser equipment
Face-to-face interviews were conducted with domestic clinic doctors who have experience introducing or considering introducing overseas laser equipment, regarding their awareness of FDA and MDSAP certifications.
As a result, data on the awareness of public certifications for overseas laser equipment was obtained.
② Questionnaire on the impact of certification acquisition information on equipment adoption decisions
A questionnaire was conducted on how much information on FDA and MDSAP certification acquisition affects actual equipment adoption decisions.
As a result, data on the tendency of the impact of public certification acquisition information on adoption decisions was obtained.
③ Awareness interviews regarding the certification acquisition status of ICONIC PICO3 PRO and others
Based on MDSAP-compliant manufacturing data disclosed from Taiwan, interviews were conducted with domestic doctors regarding their awareness of the FDA and MDSAP certification acquisition status for picosecond laser-related equipment distributed overseas, such as "ICONIC PICO3 PRO."
Our independent survey objectively confirmed that the manufacturer of this equipment has acquired certifications from the U.S. FDA (USFDA) and MDSAP (Medical Device Single Audit Program).
As a result, data on the awareness of domestic doctors regarding these certification acquisition statuses was obtained.
It should be noted that all of these are overseas certifications and do not indicate the legal positioning of individual approvals, certifications, or notifications in Japan.
Future Outlook
Since its establishment in 2019, our company has continuously interviewed domestic doctors about their needs regarding overseas medical devices.
This survey is part of that accumulation, prompted by a request from a Taiwanese corporation regarding MDSAP-certified devices, and collected and analyzed doctors' opinions on the awareness of domestic doctors regarding public certifications for overseas laser equipment.
For detailed analysis results of each survey item, please contact our company.
Our company will continue to work to improve the transparency of information regarding overseas medical devices through the accumulation and disclosure of objective data.
Survey Overview
Item: Content
Survey Period: January 15, 2025 - March 31, 2026
Survey Organization (Survey Body): MEDLAC Instrument and Consulting Co., Ltd. (MEDLAC, Inc.) Survey Development Department
Survey Target: Doctors and clinic directors of domestic clinics who have previously used our overseas medical device provision support services
Valid Responses (Sample Response Count): 32 experienced doctors (number of doctors actually interviewed or surveyed)
Survey Method:
① Awareness Survey: Face-to-face interviews with domestic doctors regarding their awareness of FDA and MDSAP certifications.
② Adoption Impact Survey: Questionnaire on the impact of public certification acquisition information on equipment adoption decisions.
③ Certification Awareness Interview: Interviews on the awareness of the certification acquisition status of individual devices such as ICONIC PICO3 PRO, based on MDSAP-compliant manufacturing data disclosed from Taiwan.
About ICONIC PICO3 PRO (Pico Three Pro)
ICONIC PICO3 PRO (Pico Three Pro) is in the medical field.
Keywords:
※This is not intended to recommend specific products, procedures, treatments, adoption decisions, or usage.
※The results of this survey are based on information independently collected and analyzed by our company and do not guarantee specific efficacy, effectiveness, or safety in Japan.
※Individual adoption and usage decisions should be made by yourself after confirming the latest public information, relevant laws and regulations, legitimate materials from equipment providers, and other necessary information.
MEDLAC Instrument and Consulting Co., Ltd. (Headquarters: Fukuoka City, Fukuoka Prefecture; Representative Director: Hideki Ogawa) has conducted an independent survey to understand the awareness of domestic doctors regarding the acquisition status of public certifications for overseas laser equipment and their actual grasp of information, and is now publishing the results.
Background of the Survey
Among overseas medical devices, some have acquired international public certifications such as the U.S. FDA (U.S. Food and Drug Administration) and MDSAP (Medical Device Single Audit Program).
However, the extent to which domestic medical professionals understand the existence and meaning of these certifications has not been sufficiently investigated or organized until now.
As a provider of information on overseas medical devices, our company conducted a survey to understand objective information regarding manufacturers' quality control systems and the awareness of domestic doctors regarding this information.
Overview of Survey Results
This survey verified and analyzed the following three items:
① Survey on awareness of public certifications (FDA, MDSAP, etc.) for overseas laser equipment
Face-to-face interviews were conducted with domestic clinic doctors who have experience introducing or considering introducing overseas laser equipment, regarding their awareness of FDA and MDSAP certifications.
As a result, data on the awareness of public certifications for overseas laser equipment was obtained.
② Questionnaire on the impact of certification acquisition information on equipment adoption decisions
A questionnaire was conducted on how much information on FDA and MDSAP certification acquisition affects actual equipment adoption decisions.
As a result, data on the tendency of the impact of public certification acquisition information on adoption decisions was obtained.
③ Awareness interviews regarding the certification acquisition status of ICONIC PICO3 PRO and others
Based on MDSAP-compliant manufacturing data disclosed from Taiwan, interviews were conducted with domestic doctors regarding their awareness of the FDA and MDSAP certification acquisition status for picosecond laser-related equipment distributed overseas, such as "ICONIC PICO3 PRO."
Our independent survey objectively confirmed that the manufacturer of this equipment has acquired certifications from the U.S. FDA (USFDA) and MDSAP (Medical Device Single Audit Program).
As a result, data on the awareness of domestic doctors regarding these certification acquisition statuses was obtained.
It should be noted that all of these are overseas certifications and do not indicate the legal positioning of individual approvals, certifications, or notifications in Japan.
Future Outlook
Since its establishment in 2019, our company has continuously interviewed domestic doctors about their needs regarding overseas medical devices.
This survey is part of that accumulation, prompted by a request from a Taiwanese corporation regarding MDSAP-certified devices, and collected and analyzed doctors' opinions on the awareness of domestic doctors regarding public certifications for overseas laser equipment.
For detailed analysis results of each survey item, please contact our company.
Our company will continue to work to improve the transparency of information regarding overseas medical devices through the accumulation and disclosure of objective data.
Survey Overview
Item: Content
Survey Period: January 15, 2025 - March 31, 2026
Survey Organization (Survey Body): MEDLAC Instrument and Consulting Co., Ltd. (MEDLAC, Inc.) Survey Development Department
Survey Target: Doctors and clinic directors of domestic clinics who have previously used our overseas medical device provision support services
Valid Responses (Sample Response Count): 32 experienced doctors (number of doctors actually interviewed or surveyed)
Survey Method:
① Awareness Survey: Face-to-face interviews with domestic doctors regarding their awareness of FDA and MDSAP certifications.
② Adoption Impact Survey: Questionnaire on the impact of public certification acquisition information on equipment adoption decisions.
③ Certification Awareness Interview: Interviews on the awareness of the certification acquisition status of individual devices such as ICONIC PICO3 PRO, based on MDSAP-compliant manufacturing data disclosed from Taiwan.
About ICONIC PICO3 PRO (Pico Three Pro)
ICONIC PICO3 PRO (Pico Three Pro) is in the medical field.
Keywords: