Jan 175 min read

Medical Device Regulations India - Frequently Asked Questions (FAQs)

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

Sep 29, 20235 min read

Navigating the Complex World of Combination Products: Understanding EU MDR Article 117

In the world of healthcare, many patients benefit from the use of combination products – medical devices that incorporate pharmaceuticals...

Sep 9, 20232 min read

UK Responsible Person (UKRP): Obligations for Medical Device Manufacturers Outside the UK

For medical device manufacturers located outside the United Kingdom (UK) without local business offices, it is mandatory to designate a...

Aug 18, 20235 min read

Biologics and Biosimilars Regulations and Registration in China (NMPA)

In China, 40% of the biologics market comprises biosimilars. The usage of biosimilars in oncology has increased as cancer overtook heart...

Jul 28, 20235 min read

Pharmaceutical Regulations and Registration in South Korea (MFDS)

The pharmaceutical market in South Korea was estimated to be worth 25.4 trillion South Korean won in 2021. The market size has been...

Jul 21, 202310 min read

FAQs - Taiwan (TFDA) Regulations for Medical Device Registration

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

Jul 19, 202310 min read

FAQ - Malaysia (MDA) Regulations for Medical Device Registration

Jul 12, 20235 min read

Pharmaceutical Regulations in Thailand

Thailand FDA Regulations for Pharmaceutical Registration

Jun 28, 20236 min read

Medical Device Regulations and Registration Process in Taiwan

Medical devices regulations and registration process in Taiwan explained

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

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

Jan 21, 20233 min read

Generic Drug Registration Requirements in Taiwan

Taiwan’s pharmaceutical market was estimated $2.9 Billion in 2021 growing at the rate of 3% CAGR Taiwan’s market is dependent on imported...

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