{"id":1860,"date":"2022-01-14T03:14:39","date_gmt":"2022-01-14T03:14:39","guid":{"rendered":"https:\/\/stendard.com\/?p=1860"},"modified":"2023-07-25T17:11:44","modified_gmt":"2023-07-25T17:11:44","slug":"regulatory-strategy","status":"publish","type":"post","link":"https:\/\/stendard.com\/en-sg\/blog\/regulatory-strategy\/","title":{"rendered":"What is a Regulatory Strategy? How can I create one?"},"content":{"rendered":"\n

A regulatory strategy is often a formal plan that aligns regulatory activities to business strategy, so as to bring a new or modified medical device product to market. Formulating this plan would require your consideration of various regulatory issues in the target markets you wish to place your product. When well planned, your regulatory strategy should be balanced, realistic, achievable, and in support of your organisation\u2019s mission and vision. It identifies important regulatory requirements to be addressed and provides overall definition and clear direction for your product development team, even outlining the reasons for the path to be taken.<\/p>\n\n\n\n

Planning your regulatory strategy should be done at the earliest possible stage of product development, while you are putting your D&D work structure in place. Here are 3 points to consider with specific regard to regulatory concerns:<\/p>\n\n\n\n

  1. Target markets for commercialisation<\/li>
  2. Medical Device Classification<\/li>
  3. Overall project milestones and timeline<\/li><\/ol>\n\n\n\n

    1) Target markets for commercialisation<\/strong><\/h2>\n\n\n\n

    \u201cWhich countries do I want my product to be sold in?\u201d<\/em><\/p>\n\n\n\n

    It is important to know which markets you want to sell in, and prioritise the various market entries. Different markets have varying market size, medical practices, pricing and reimbursement, as well as distribution activities. Furthermore, regulatory regimes differ between markets. You would need to evaluate all these different factors when considering your regulatory strategy. It can be helpful for your D&D plans as well.<\/p>\n\n\n\n

    An example of regulatory difference is the risk classification of medical devices, where the same product might be classed slightly differently under different regulatory regimes. With this differentiation, the timing and ease of product release could be affected as well.<\/p>\n\n\n\n

    2) Product Classification<\/strong><\/h2>\n\n\n\n

    \u201cWhich risk classification does my medical device belong to?\u201d<\/em><\/p>\n\n\n\n

    As mentioned above, medical device classification is important in establishing the pathway to a specific market. When you have clearly established the options and requirements for your \u201croute to market\u201d, you can better plan your product development with a \u201cgo-to-market\u201d strategy.<\/p>\n\n\n\n

    Here are some links to a few of the more common regulatory markets to help you determine this:<\/p>\n\n\n\n