Jul 20, 20238 min read

Medical Device Regulations and Registration Process in Thailand

Medical Device Regulations and Registration Process in Thailand The production of medical devices in Thailand was estimated around 4.9...

Jul 19, 202310 min read

FAQ - Malaysia (MDA) Regulations for Medical Device Registration

Jul 12, 20237 min read

Medical Device Regulations and Registration Process in Argentina, ANMAT

ANMAT is an Argentine regulatory authority responsible for the regulations governing registration process of medical devices

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 8, 20232 min read

Government Schemes for Funding and Financing Medical Devices in India

In recent times, there has been a significant push from Government of India for funding and financing medical devices innovation and...

Jul 8, 20233 min read

Medical Devices Innovations in India

The medical device market in India is projected to grow at a CAGR of 15.7% between 2021 and 2026, reaching a size of USD 50 bn by 2030

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, 20231 min read

What are the Responsibilities of an Indian Authorized Agent for Medical Devices Import?

An Indian Authorized Agent must fulfill critical responsibilities detailed in the Medical Device Rules (MDR), 2017 to be able to import

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.

Jun 12, 20233 min read

Medical Devices Registration Regulations by Singapore HSA

Singapore Medical Devices Registration as per Health Sciences Authority Regulations for four Class

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

Jun 30, 20220 min read

Pathway for Clinical Evaluation Medical Devices

Jun 30, 20221 min read

Template for Literature Search and Screening for Clinical Evaluation of Medical Devices

The literature search and screening report for clinical evaluation of medical devices must be compiled covering following parameters.

Insights

Global, Concurrent, Experience Based

Deep dive and engage in insightful discourse driven by concurrent global regulatory scenarios, industry trends and Artixio’s real-time experience across the product value chain. Whitepapers, research articles, landscape reports and case studies to help you stay ahead of the curve.

global regulatory intelligence pharma medical device cosmetics food animal tool