Medical Device Regulations India - Frequently Asked Questions (FAQs)
Frequently asked questions (FAQs) regarding medical device registration and regulations in India
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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
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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