Medical Device Registration in Singapore – Pre-submission Meetings with Health Sciences Authority
Singapore's reputation as a global healthcare and innovation hub has made it an attractive destination for medical device manufacturers...
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Oct 9, 20234 min read
Understanding the Role of PRRC under EU MDR and IVDR
The advent of the EU Medical Device Regulations (EU MDR) and In-Vitro Diagnostic Regulation (IVDR) signals a new era of intensified...
Oct 8, 20235 min read
Medical Device Registration in Singapore : Evaluation Processes by Health Sciences Authority (HSA)
The realm of medical device registration in Singapore comprises a intricate network of rules, recommendations, and procedures designed to...
Oct 5, 20234 min read
Types of Medical Device Approval Licenses Issued by CDSCO in India
The healthcare sector holds a vital position in safeguarding the health of a nation's people, with the utmost importance placed on the...
Sep 30, 20233 min read
Class I Medical Devices and CE Marking: Compliance Essentials
The European Union (EU) boasts one of the most stringent regulatory frameworks for medical devices in the world. For manufacturers...
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 28, 20234 min read
Certifying Medical Devices in the EU: The Crucial Role of Notified Bodies under MDR and IVDR
In the ever-evolving world of medical devices, Notified Bodies play a pivotal role in ensuring the safety and efficacy of products...
Sep 15, 20234 min read
Conformity Assessment of Medical Devices under EU MDR
The world of medical devices is a realm of constant innovation, where the development of new technologies has the power to transform...
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, 202310 min read
FAQs – Australia (TGA) Regulations for Medical Device Registration
The regulatory authority responsible for medical device registration in Australia is the Therapeutic Goods Administration (TGA)
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 20, 202310 min read
FAQ - Singapore (HSA) Regulations for Medical Device Registration
The Health Sciences Authority (HSA) is the regulatory authority responsible for medical device registration in Singapore.
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
FAQ - Malaysia (MDA) Regulations for Medical Device Registration
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
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