After lengthy discussions, we have followed the authority instructions on registering the product as a medical device due to the following benefits:
The price of the product could be set without any restrictions from the health regulators in the destination country, whereas the regulators strictly controlled the pricing of pharmaceutical products.
The registration fees for medical devices were lower than for pharmaceutical products.
And finally, a circumstance unique to the attributes of this product meant that a stability study related to the shelf life of the product was submitted and accepted to get the final approval .
This case study highlights the need for conducting meticulous research and discussing all options available before taking any action. When it comes to product registration and all the different countries’ regulatory frameworks, it can pay huge dividends to understand all implications before any applications are made. Our client was satisfied with the result and now enjoy the benefits of bypassing the strict pharmaceutical standards they were facing initially.