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Medical Device, Diagnostics Regulations in Taiwan FDA - Frequently Asked Questions (FAQs)

The regulatory authority responsible for medical device registration in Taiwan is the Taiwan Food and Drug Administration (TFDA)

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Medical Device Regulations India - Frequently Asked Questions (FAQs)

Frequently asked questions (FAQs) regarding medical device registration and regulations in India

Jul 31, 20235 min read

Medical Device Regulations in Colombia: A Comprehensive Guide

In 2023, the Medical Devices market in Colombia is expected to achieve an impressive revenue milestone of US$2.00 billion. This reflects...

Jul 21, 20237 min read

Medical Devices Regulations and Registration in Indonesia

Medical Devices Regulations and Registration in Indonesia Although the manufacturing sector for medical devices in Indonesia is...

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 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.

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