FAQ - Mexico (COFEPRIS) Regulations for Medical Device Registration
Here are answers to some of the Frequently Asked Questions about Mexico Medical Device Regulations.
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Jul 7, 20236 min read
Australia (TGA) Medical Devices Regulations and Registration Process
Medical devices in Australia shall be approved under regulations governed by the Australian regulatory authority called TGA
Jul 4, 20238 min read
United Kingdom (UK) - Medical Device Regulations and Registration Process (MHRA)
Registration process for medical devices as per regulations in the United Kingdom (UK) MHRA
Jun 28, 20236 min read
Medical Device Regulations and Registration Process in Taiwan
Medical devices regulations and registration process in Taiwan explained
Jun 28, 20235 min read
Medical Device Regulations in China (NMPA)
National Medical Products Administration (NMPA) Governs Regulations for Medical Devices in China
Jun 26, 20235 min read
Mexico (COFEPRIS) Regulations for Medical Device Registration
COFEPRIS in Mexico governs the regulations for registration of medical devices
Jun 26, 20235 min read
Medical Devices Regulations in European Union (EU MDR)
The European Union (EU) follows medical device regulations (EU MDR) that safeguard patient health and provide a regulatory framework
Jun 22, 20235 min read
Vietnam Regulations for Registration of Medical Device
In Vietnam, manufacturers and importers of medical devices must undergo a registration process overseen by the Medical Device Administration
Jun 20, 20232 min read
Expanded Access by USA FDA for Investigational Drugs
In the United States, the approval process for unregistered medicinal products under Early Access Program (EAP) is known as Expanded Access
Jun 20, 20232 min read
Named Patient Program in India (CDSCO)
The Named Patient Program approval process is designed to provide patients with access to investigational drugs that are not yet approved
Jun 20, 20232 min read
Early Access Program (EAP) and Approval process for unregistered medicinal products in Cambodia
The Early Access Program approval will allow the applicant to import and distribute the unregistered medicinal product in Cambodia.
Jun 20, 20232 min read
DAV Introduces New Drug Registration Process in Vietnam
The new drug registration process in Vietnam was introduced by DAV (Drug Administration Vietnam) in October 2022
Jun 20, 20232 min read
COFEPRIS Introduces Changes to Drug Registration Process in Mexico
The Mexican health authority, COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), has a new drug registration process
Jun 19, 20232 min read
Regulations for Registration of Medical Device in India (CDSCO)
Regulations for Registration of Medical Device in India is overseen by the Central Drugs Standard Control Organisation (CDSCO)
Jun 19, 20235 min read
Medical Devices Regulations in Hong Kong: Ensuring Safety and Quality
In Hong Kong, the Medical Device Control Office (MDCO) under the Department of Health oversees the regulations of medical devices.
Jan 27, 20232 min read
Medical Devices Registration with Medical Device Authority (MDA) in Malaysia
Medical Devices in Malaysia re regulated by Malaysian Medical Device Authority (MDA). The Medical Devices need to be registered in Malaysia
Jan 23, 20232 min read
Indonesia - Regulations for Drug (Pharmaceutical) Registration
The National Agency of Drug and Food Control (BADAN POM) supervises drug and food control in Indonesia under the Health Law No. 36 of 2009.
Jan 21, 20232 min read
Marketed Pharmaceutical Products Lifecycle Management in Asia
Artixio’s Proven Experience in Managing Lifecycle for Marketed Products in Asia
Mar 1, 20227 min read
Pharmaceutical Regulations and Registration in Singapore
Drug Registration Process in Singapore per Regulations from Health Sciences Authority.
Feb 12, 20225 min read
Pharmaceutical Regulations in China
National Medical Products Administration (NMPA)
Main regulatory body in China which handles pharmaceutical drug registration management
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