Role of Qualified Person Responsible for Pharmacovigilance (QPPV) in the EU
In the intricate landscape of pharmaceutical regulation, ensuring the safety and efficacy of medicinal products is paramount. At the heart […]
Importing Medical Devices in Thailand: Process and Regulations
In today’s globalized healthcare landscape, the importation of medical devices plays a crucial role in ensuring cutting-edge technologies and life-saving
Medical Device Regulations & Registration Process in Thailand
The production of medical devices in Thailand was estimated around 4.9 million U.S. dollars in 2022. The total market size
Class II & III Medical Device Registration in Indonesia
Every country has its rules and regulations for medical devices, which must be followed to bring the medical device to
COFEPRIS Advertising Permission for Food Supplements in Mexico
If you’re a natural or legal person providing health services, beautification procedures, or promoting the consumption or sale of various
Medical Device Regulations in China (NMPA)
China has become a leading force in the world of medical devices, thanks to its booming market and stringent regulatory
Vietnam Regulations for Registration of Medical Device
In the last few years, Vietnam’s healthcare sector has undergone significant growth, accompanied by a rising need for more advanced
Case Study: ASEAN Regulatory & Market Access Strategy for Japanese Pharmaceutical Manufacturer
Artixio, a leading consulting provider in the regulatory and commercial landscape, assisted a Japanese pharmaceutical company in expanding its footprint
Case Study: Artixio’s Successful Registration of a Surgical Device with Taiwan FDA
This case study demonstrates Artixio’s Successful Registration of a Surgical Device in Taiwan with FDA. Client: A leading global surgical