ABSTRACT
Regulatory strategy is an important planning that helps the company to understand the regulatory requirement, the required resources, and the estimated timeline to register and seek approval from the local authority of the countries of interest. Some countries have abridged or shorter time application routes for a medical device with approval from the benchmark reference agencies and/or a medical device with significant clinical benefit for the patient population example, innovative products, specific clinical diagnosis, and treatment products. Regulatory strategy should be prepared whenever the company is developing a new product or modifying a current registered product. Each country has its registration route or conformity assessment route for the manufacturer to demonstrate that the product meets the safety and performance requirement before it can be imported and/or placed in the market. The technical documentation consists of information on how the medical device was designed, developed, and manufactured.
