Oct 10, 20236 min read

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...

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

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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