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Our manufacture date is indicated under the Manufacturer symbol per ISO 15223-1, as exampled in Annex A. Since we know the exact manufacturing date based on the lot number and the risk of our product is very low, Class I Exempt in the US and Class I in all other countries to which we export, we only ...

Dear Sushma, According to my research only implantable devices are required to be registered in Lebanon. This information was correct as of January 2024. REGULATORY AUTHORITY: The two bodies regulating medical device registration in Lebanon are The Drug Import and Export Department and The ...

Dear Anon, All service providers are required to be on your ASL. This includes but is not limited to your chosen shipping company, your pest control provider, facility contractors, ISO consultant, distributors, importers etc. Simply put, your ISO certification requires this along with the FDA QSR. ...

Hello Arslan, Here is what I know about Argentina: ANMAT - Resolution 3802/2004 - For Class I devices, manufacturers must only provide the declaration of payment, manufacturer/importer identification information, and declaration of compliance with Mercosur legislation. All medical device labels ...

Good Day Anon, The regulations for Class I devices as you describe have recently changed. However, Manufacturers without an established place of business in Brazil must appoint an in-country representative known as the Brazil Registration Holder (BRH). The BRH submits the registration application and ...