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As originally asked by Mads Kaae.

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Nancy Knettell, MSMgmt
Founder and Principal at SoftwareCyber510K
In order to have a medical device approved for the American market you have to prepare either a 510K or PMA if no predicate exists and or it is a class III device, a quality system — IEC13485 at least with add ons to support the CFR — and proof of having followed it throughout the life cycle of the project, sufficient clinical trial evidence, along with an agent in the US who can help you to move forward with the submittal. There is a company in Amsterdam called Business Support International that has a proven track record of doing this in the past for other companies in Europe. They have an agent in the US. If you are interested I can get their contact information and forward it to you.

John Strobel
Global Strategy Development and Execution (Medical Device and Industrial)
If funds are very limited, find a distributor you can trust, but ask for copies/updates of the documents and process along the way (Pros: local knowledge and small investment, Cons: May not allow other distributors to register in some countries, and locks you into this company).

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.

Laurence Newman
CEO, Currentbody.com
Having successfully obtained a 510k, I fully agree with Paul Zalesky’s comments at the start of this thread. A good regulatory consultant is essential. Where the FDA is concerned, be prepared for what can be a long and expensive process (depending on the product).

Mads Kaae
Internal Auditor and Project Manager
I’ll see what i can do and send it to you.

Olufemi Adeoye
Regulatory Affairs & Quality System Professional
A product manual will be perfect, alternatively; give me the general name of the product(e.g. catheter or laser device), how it works, where its used in the body, who use it (i.e. can the patient use it alone or it is only used by professionals on patients) and details of what it is used for (i.e. indications).

Mads Kaae
Internal Auditor and Project Manager
Do you have an example of the information that i need to send you?

Olufemi Adeoye
Regulatory Affairs & Quality System Professional
The fact is the US, Canada and EU medical device approvals will make your device registration procedure easier in several 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).
Feel free to contact me; we have US, Canada and EU experts in regulatory (both pre-approval and post-approval management) and quality system/assurance related issues for any medical device, drugs(OTC, generic or new molecules) or biologic, veterinary and cosmetic products.

Aejaz Shah
General Manager
We have SFDA in Saudi Arabia which is categorized in three phases.
Phase I : requires following documents. GHTF Founding jurisdictions (Australia, Canada, Japan, USA, EU): SFDA Certification Requirements attached and Self Declaration of Conformity Letter. The purpose is to obtain MDNR(Medical Devices National Registry) Number.

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.
Items are also categorized.1. Medical equipments .2. Temperature controlled items (having specific temp range) . Frozen items(especially for medical laboratory. Temp.
data loggers are must and will be checked at destination for temp. monitoring within the limits!! (It is not easy to import now)!! One has to abide by these regulations.

Michelle Bonn
President, Guideline Medical
Mads,

Good advisement will depend on the type of device you are trying to develop & market? Are you able to provide product details?

Michelle

Jeff Davis
National Sales and Marketing Director
Emergo is a consultation company that has a great website which list all the countries requirements

Paul Zalesky
Medical Specialty Consultant
Reach out to a seasoned regulatory consultant who has been involved with myriad device types and can quickly identify the key regulatory review issues and associated submission path.