The medical device industry in Korea has been growing rapidly. This growth is a testament to the quality and innovation of medical devices manufactured in Korea, which are increasingly being exported globally. A critical factor in determining the safety and efficacy of Korean devices is their adherence to Korean Good Manufacturing Practices (KGMP), as recommended by the Ministry of Food and Drug Safety (MFDS).

Brazil, the largest economy in Latin America (LATAM), is also the most promising medical device market in the region. The medical device market in Brazil is governed by the Agência Nacional de Vigilância Sanitária (ANVISA), or the Brazilian Health Regulatory Agency, which came up with a new resolution titled RDC 751, effective from March 01, 2023.

As digital health startups continue to disrupt traditional healthcare practices, businesses must be compliant with regulations to ensure sustainable success. However, achieving Regulatory compliance can be a complex and arduous task. Thus, startups must adopt suitable strategies that will help them navigate the ever-changing Regulatory landscape. This blog outlines ten (10) strategies that digital health startups can follow to ensure compliance, and in turn, successful continuation of operations. Let us now explore the strategies in further detail:

Medical devices in Mexico are regulated by the Secretariat of Health (Secretaría de Salud). Article 262 of the Mexican General Health Law requires all medical devices to be registered with the Secretariat of Health before being placed in Mexico. The Federal Commission for Protection of Sanitary Risks (COFEPRIS) oversees the registration process of healthcare products. The Regulatory structure is composed of mandatory standards that are known as Normas Oficiales Mexicanas (NOM) and voluntary standards that are known as Normas Mexicanas (NMX).

In December 2018, the United States Food and Drug Administration (US FDA) published the final guidance on Manufacturing Site Change Supplements: Content and Submission. Replacing the 2015 draft guidance, the final guidance clarifies the responsibilities of medical device manufacturers who are willing to change their manufacturing site for an approved device.