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Can the regulatory strategy define medical device marketing strategy?


Regulatory strategy defines a pathway for the market access of your medical device. It helps to understand the regulations which underpin market entry to form the base of your medical device marketing function.


Gaining access to regional markets is always preceded by regulatory approvals. It indicates that your medical device regulatory strategy is intertwined with your marketing strategy. Estimation of cost, timeline and complexities of approval activities are dependent on the regulatory requirements. Classification of Risk defines the regulatory path globally. This risk classification highlights the level of regulatory scrutiny applicable to your medical device.


In order to classify the risk of your product, you need to identify:

The completion of Product Design will initiate the regulatory pathway process. This pathway is a crucial element of the regulatory strategy. In order to create a regulatory strategy, the manufacturer must be aware of the following facts:

Unlike others, the market approval process for a medical device is time-consuming and restricted by medical device Rules and Regulations. In such a scenario, it is essential to plan the source and availability of resources.

At times, regulatory confirmation from one country can directly give access to other countries. For example, ISO 13585:2016 Quality Management System is recognised and accepted in several countries.

To place the product in any new territory, the manufacturer should have complete information about the target market. This information will play an important role in the device regulatory strategy.


Irrespective of the market restraints, many medical companies target a market for economic advantage. Therefore, every manufacturer should have detailed information about the target market and the players/economic operators required before marketing to exploit the opportunity.


Since the regulatory pathway paves the way for marketing, manufacturers can easily plan and estimate the cost, service requirements and decide on access requirements. The regulatory pathway enlists a series of activities where each activity can form the basis of marketing activity. The regulatory strategy suggests vital elements and factors which can affect the medical device. Irrespective of having a local representative, a marketing strategy can be negatively impacted if the mandatory regulatory requirements are not considered.

Get your regulatory strategy working for you and your product’s marketing by connecting with Med-Di-Dia’s experts

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