subject: Getting Market Approvals For Your Medical Devices [print this page] Gaining market approval from international regulatory bodies is important for promotion of new brands. Even in the case of promotion of medical devices and lab equipments in a new market, it is important to fetch market approval certifications from various regulatory bodies in that region.
There are several medical device and lab equipment manufacturers around the world who plan to launch their products in different geographical territories. These manufacturers are either well-established companies or are upcoming market newcomers who plan to establish their market in a new region. The prime concern for these manufacturers is to gain credibility in the market.
One can establish their credibility in the market and get entrance into the supply and demand chain with the help of regulatory certifications. Regulatory certifications are unique and special to every region. Each country has a different set of regulatory norms and criteria for issuing these regulatory certifications. Some of the certifications for market approvals include FDA for Medical Device Clearance, FDA GMP Quality System Audit, and ISO 14971:2007 for risk management, Medical Device License (MDL), MDEL, Canadian Medical Device Regulations (CMDR) and ISO 13485:2003 for Quality System Implementation or Modification etc.
There are various quality and experienced medical device consultants in the market offering consultation for acquiring these certifications. They offer quality advice and help in understanding the different norms and standard guidelines for getting market approvals for promotion of a product within a given region. Hence, it is important that medical device manufacturers hire services of a qualified and an experienced medical device consultant.
These medical device consultants are in a much better position to advice both established as well as emerging medical device and lab equipment manufacturers in making a mark in a niche market. They offer expert consultation in foraying into a new market by receiving market approvals. Their close association with regulatory bodies throughout the globe helps their clients in easy accumulation of certifications for venturing into a new market by satisfying the set guidelines of a region.
