Jul 9, 202310 min read

FAQ - Mexico (COFEPRIS) Regulations for Medical Device Registration

Here are answers to some of the Frequently Asked Questions about Mexico Medical Device Regulations.

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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