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The services WISE COMPANY offers.
The main news from WISE COMPANY.
We are experts in medical device and cosmetic certification processes of a lot of countries. Kinda sorry to say this but as all regulatory requirements get more and more strict, we are getting better and better with our skills, knowhow and income.
We founded our company at Apr. of 2016. I know you might think we are too young and inexperienced, and you may. We know and acknowledge there are a lot of experienced experts in the fields of medical device and cosmetic regulatory affairs.
China is now looking inside to protect their domestic industries.
China is alredy closing their market for foreign companies in medical devices, cosmetics, electronics, and cultural industries.
Changes of certification and approval requirements of E.U. and U.S. has possibility to influence other countries because most of the coutries have adapted either European or U.S. system into their own.
Medical device(hereinafter, CE MDD) certification in European counties is getting more and more difficult since 2013.
The European Commission has begun applying fourth amendment of Guideline for Clinical Evaluation (MEDDEV 2.7/1 Rev. 4) from June 2016, and another word for European medical device certification is clinical evaluation.
The history of WISE COMPANY.
MDR project status as of Nov. 1st, 2023
›› Anti-Adhesion Barrier Gel (Class III / Certificate issued)
›› Handheld Ultrasound Scanners (Class IIa / Certificate issued)
›› Surgical Battery Power Tools (Class I-r / Certificate issued)
›› Cross-linked Hyaluronic Acid Dermal Filler with Lidocaine (Class III / Finished drug review)
›› Catheters for Eustachian & Sinus Balloon Diatation (Class I-s / Finish TD review)