Registering your medical device for sale in Israel requires you to appoint a representative if you have no local presence. In Israel, the representative role is performed by an Israel Registration Holder (IRH). Emergo provides this service through our local office in Israel.
If you select Emergo as your IRH, we will submit your registration documents to AMAR, the medical device division of the Israeli Ministry of Health. We would then serve as your regulatory representative in Israel, holding your device approval. Your IRH is also responsible for acting as a liaison between you and regulators at AMAR, and must be identified on your device registration documentation. You must maintain IRH representation for as long as you sell your device in Israel.
Reasons for Selecting an Independent IRH
Although choosing your medical device distributor to act as your regulatory representative in Israel is certainly an option, using a professional, independent third party such as Emergo to fulfill your IRH obligations avoids the following issues:
- Avoiding potential problems associated with switching distributors if a poorly performing distributor is also your IRH
- Competitive problems if one distributor acts as your IRH and you want to appoint a second distributor
- Having to entrust your distributor with your proprietary product design information
- Dealing with conflicts of interest with your distributor in the event of a product recall or incident report to AMAR
- Having to rely on your distributor for regulatory updates in Israel
An independent IRH such as Emergo can better control your device registration and distributor relationships without causing the same potential conflicts of interest that using a distributor as your IRH may cause. An independent IRH is also better equipped to assist you in dealing with inquiries from regulators.