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Does anybody have good advise or good articles about getting medical devices approved by FDA or similar in other countries?
< 1 min reading time
As originally asked by Mads Kaae.
Nancy Knettell, MSMgmt
If you have more resources and are prepping for the long term, use a consultant or third party registrar. Emergo was mentioned-they get the job done but are not cheap.(Pros: You own/control the registration, Cons: Price based on sales volume and per diem items which add up fast)
Once you are established consider hiring a team in country to drive your commercial and registration needs(Pros: Full control, massive increase in local knowledge, lower registration costs, may drive revenues faster Cons: higher total overhead, potential turnover, could be difficult to manage if not familiar with international business).
We are at varying stages of each of these in different countries.
If I have the description of your product(s) and intended use, I will be able to give you the best advise for US FDA and Health Canada. For some devices with low risk you do not need an approval, I can only classify this with the description of your product(s) and intended use.
I have obtained approvals for devices with Health Canada and US FDA. Good news is in Canada and the US, you do not require a local office to have your product approved though you require a US local agent to sell in the US; it is not mandatory in Canada but all importers must have an establishment license (Class I devices in Canada will require an establishment license if manufacturer decides to sell directly to consumer/retailers).
Phase II :Agreement between Manufacturer and Authorized Representative: (Sample Agreement from SFDA is provided to the manufacturer). To be printed on their letterhead, signed and stamped by both companies, legalized from manufacturer side by:
a) Chamber of Commerce in(their) foreign country b) The Ministry of Foreign Affairs in foreign country c) The Saudi embassy in the foreign country and legalized at our side from the Saudi Ministry of Foreign Affairs. The purpose is to obtain MDEL (Medical Devices Establishment License) Registration; to assign authorized representative for the manufacturer in Saudi Arabia
Phase III : Attestation accompanying application for Marketing Authorization. (Sample document will be attached) to be printed accordingly on manufacturers / exporters letterhead, signed and stamped. They should include whole line of products that they want to market in Saudi Arabia in this document. Purpose is to obtain MDMA (Medical Devices Marketing Authorization) Registration; to get Marketing License for the line of products of the manufacturer in Saudi Arabia
Once fully registered, the company in Saudi Arabia can import the listed items.
Good advisement will depend on the type of device you are trying to develop & market? Are you able to provide product details?
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