The European medical devices market, being the second largest in the world, is majorly driven by a growing patient population, technological advancements, and increasing healthcare expenditure. However, when it comes to expanding the medical device business into the European geography, a complex web of regulations and recent geopolitical changes adds an extra layer of challenge.

An Overview of Document Registration for Medical Devices in Turkey

The Guidelines for Registration Review of Radio Frequency (RF) beauty devices in China is a consolidated document that guides registration applicants and technical review departments on how to prepare registration application materials for RF beauty devices.

These guidelines are meant specifically for RF beauty devices, which include devices used for skin treatment, fat reduction, and other cosmetic purposes; such devices use high-frequency current to act on the human body.

The advancement of medical devices has revolutionized patient care and treatment outcomes.

Complaint handling is an integral part of medical device companies’ Quality Management System (QMS). It involves receiving, investigating, and resolving customer complaints related to medical device products and services provided by an organization. Such complaints are related to the safety, performance, or effectiveness of medical devices, as per ISO 13485. Companies must address complaints promptly and effectively to maintain customer satisfaction and uphold Regulatory compliance.

The previous blog on the Fast-break Scheme (Part 1) discussed Japan’s conditional early approval system for innovative medical devices, covering four (04) essential steps, the rationale and requirements for the application review process, the eligibility criteria, the application submission process, the MHLW and PMDA’s Regulatory guidelines, the review process, eligibility without pre-development consultation, and the key considerations for describing eligibility summaries.

The Health Sciences Authority (HSA) is Singapore's Regulatory agency in the sphere of healthcare products. Importers and wholesalers dealing with medical devices in Singapore should develop a medical device Quality Management System (QMS) that conforms to the requirements of the Good Distribution Practice for Medical Devices (GDPMDS). SS 620: 2016 is the Singapore Standard for Good Distribution Practice for Medical Devices (SS620 GDPMDS).

The US Food and Drug Administration (USFDA) has proposed the harmonization of the 21 Code of Federal Regulations (CFR) Part 820 Quality System Regulation (QSR) for medical devices in accordance with the International Organization for Standardization (ISO) 13485:2016.

As digital health startups continue to disrupt traditional healthcare practices, businesses must be compliant with regulations to ensure sustainable success. However, achieving Regulatory compliance can be a complex and arduous task. Thus, startups must adopt suitable strategies that will help them navigate the ever-changing Regulatory landscape. This blog outlines ten (10) strategies that digital health startups can follow to ensure compliance, and in turn, successful continuation of operations. Let us now explore the strategies in further detail:

A Quality Management System (QMS) refers to a set of systems and processes that a company adopts to ensure the quality of its products and services. In the Medical Device industry, a QMS is essential for ensuring the safety and efficacy of devices.