Local Representative for MDR in Mexico:Mexican Registration Holder (MRH) for COFEPRIS Communications
In recent years, Mexico has emerged as a highly attractive destination for businesses looking to expand their operations, particularly in […]
Responsibilities of Indian Authorized Agent for Medical Devices Import
An Indian Authorized Agent is an intermediate between the foreign manufacturer and the regulatory authority. Any foreign manufacturer who intends
CDSCO Manufacturing License for Cosmetics in India
In India, the cosmetic industry is burgeoning, with a plethora of domestically manufactured products gracing the market every day. However,
Registration of Biologics in Malaysia (NPRA)
Biologics have emerged as a significant treatment for various diseases in Malaysia. With their increasing relevance in addressing chronic diseases
Biologics and Biosimilar Regulation and Registration in Japan (PMDA)
With the exception of the United States, Japan’s biosimilar business, with a market value of $140 million, accounted for just
Regulations of Reusable Medical Devices under EU MDR
The introduction of the EU Medical Device Regulation (MDR) has brought increased emphasis on robust data and comprehensive evaluations for
System and Procedure Packs in Accordance with EU MDR
In today’s healthcare system, the role of system and procedure packs is of great importance. Since these packs contain tools
DIGIPRIS: Mexico COFEPRIS Digital Platform for Product Registrations and Regulatory Submissions
DIGIPRIS system (Sistema Digital de Procesos y Servicios Regulatorios, or Digital System of Regulatory Processes and Services) is a digital
Post-Market Surveillance In Medical Device Regulation
One of the biggest accomplishments in the journey of a drug product is its entry into the market as a