• Overview

    Different countries can have unique ways to classify various products, and they have different regulations for marketing and selling those products. In this case study, we explore a situation where a medical device was classified differently in the country of origin than the country it was being registered in, which caused issues regarding certifications and government approvals.
  • The Challenge

    The country where our client needed their product registered had classified the product as a medical device. However, it was classified as a pharmaceutical product in the country of origin. On further discovery, it turned out that the classification was somewhat ambiguous. The challenge here was to find the optimal solution based on several factors.

The Solution

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.

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