According to Israel Medical Device Law, the AMAR submission should be made through a professional and skilled party, the Israeli Registration Holder (IRH). IRH must be by an Israeli citizen or a corporation established in Israel.
BioReg Services is an Israeli regulatory affairs boutique consultancy firm with more than 15 years of experience in Regulatory Affairs and liaison with the Israeli Ministry of Health Medical Device department (Israel MoH – AMAR) and hundreds of registered devices.
As part of the IRH service, we are responsible for contacting the Israel MoH, reporting incidents (vigilance), providing post-marketing surveillance reports, and performing registration updates as the law requires.
Usually, we can prepare an AMAR submission in 2-3 weeks, followed by the AMAR review, which could take three months on average.
For more information, please contact the BioReg team.
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