Several countries require an in-country representative. This company is often chosen by the marketing department to market and distribute the medical devices in the country. But is this really the best strategy when it also includes being the regulatory contact with the authorities?
The marketing department is without doubt the best department to choose sales representatives and distributors. However, they may not be the best to evaluate if a distributor has sufficient knowledge of the regulatory requirements. Since the country representative is your spokesperson towards the authorities concerning registration, product changes and vigilance in some cases, they need to have appropriate knowledge about these issues. Additionally, manufacturers often depend on this company for keeping them up to date with changes in the local regulations and sometimes require assistance to determine if a product change need notification. This is not something you want to get it wrong.
But to be fair, you also need to see the selection of the distributor from the view of the marketing department. What’s the point of a distributor who knows the regulations by heart but wouldn’t be able to sell life jackets on the sinking Titanic.
Another important aspect to consider when choosing an in-country representative is that if you are dissatisfied with a distributor and wish to change, it can be a cumbersome and expensive endeavour if the distributor also is the registration holder. It can end up in a scenario where you will have to buy the registration from them or start the registration process from the beginning with a new distributor.
So, as always; Plan before Do.
Determine exactly what the local representative must be responsible for and limit the contract to those areas. If possible, determine that you, the manufacturer shall be the registration holder. If this is not possible, my advice is to use an independent regulatory affairs contractor as your licence holder. This way you can appoint whomever and as many distributors as you want. Obviously, the distributors will still have some regulatory obligations, but these would be limited to things like traceability and complaint/vigilance procedures. Authority contacts and registration updates would be routed through the RA-contractor. The RA-contractor can also be very helpful if the local health authority would like to do an audit on your facility which is not uncommon.
Noteworthy, is also the fact that the distributors often provide a template for what the Letter of Authorization should look like. This is very convenient, but make sure that you really want to give them all the authority that is described in the template. Additionally, it is a good idea to set an end date of the contract or a clause on how the termination should be conducted. This is to avoid any trouble in the future. Depending on the complexity, it can be good to have a legal person to review the contract before signing.
There are a lot of things to consider before you enter the new market, but to quote Arthur Miller; “The jungle may be dark, but it´s full of diamonds.”