Markets | Which market will you access next?

Brazil

Deviceology is uniquely positioned to assist clients in navigating the complexities of the Brazilian Medical Devices market. Leveraging our extensive expertise in international regulations and ISO standards, such as ISO 13485 for quality management and RDC 16/2013 for Good Manufacturing Practices (GMP), we offer a comprehensive suite of services that facilitate market entry.

Our team provides invaluable guidance on regulatory compliance, ensuring that your medical devices meet the stringent requirements set forth by the Agência Nacional de Vigilância Sanitária (ANVISA) in Brazil. We also offer insights into the Medical Device Single Audit Program (MDSAP), enabling manufacturers from the U.S., EU, and other MDSAP-recognised countries to use regulatory clearance information for a smoother approval process in Brazil.

Moreover, Deviceology understands the market dynamics and consumer demands in Brazil, which is crucial for successful market penetration. We offer market research services that identify potential gaps in the market, as well as areas of growth—such as cardiology and orthopedic devices, which are seeing increased demand due to Brazil’s diverse and growing population.

Our end-to-end solutions, from market research to market launch, are designed to not only meet regulatory and international standards but also to align with Brazil’s healthcare policies and expenditure patterns. This includes compliance with INMETRO regulations for medical devices, as well as understanding the intricacies of the Brazilian Unified Health System (SUS).

By partnering with Deviceology, clients can expect a streamlined, compliant, and strategic entry into the lucrative Brazilian Medical Devices market.

Australia

Deviceology is uniquely positioned to assist clients in navigating the complexities of the Australian Medical Devices market. Leveraging our extensive expertise in international regulations and ISO standards, such as ISO 13485 for quality management, we offer a comprehensive suite of services that facilitate market entry.

Our team provides invaluable guidance on regulatory compliance, ensuring that your medical devices meet the stringent requirements set forth by the Therapeutic Goods Administration (TGA) in Australia. We also offer insights into the Medical Device Single Audit Program (MDSAP), enabling U.S. manufacturers to use FDA regulatory clearance information for a smoother approval process in Australia.

Moreover, Deviceology understands the market dynamics and consumer demands in Australia, which is crucial for successful market penetration. We offer market research services that identify potential gaps in the market, as well as areas of growth—such as cardiology and orthopedic devices, which are seeing increased demand due to Australia’s ageing population.

Our end-to-end solutions, from market research to market launch, are designed to not only meet regulatory and internatinal standards but also to align with Australia’s healthcare policies and expenditure patterns. By partnering with Deviceology, clients can expect a streamlined, compliant, and strategic entry into the lucrative Australian Medical Devices market.

Canada

Deviceology excels in guiding clients through the intricate landscape of Canada’s Medical Devices sector. With a strong foundation in international regulations and ISO standards, including ISO 13485 for quality management systems, we provide an all-encompassing range of services to ease your entry into the market.

Our specialists offer crucial advice on meeting the rigorous regulatory standards enforced by Health Canada. Additionally, we provide an in-depth understanding of the Medical Device Single Audit Program (MDSAP), which allows manufacturers from MDSAP-participating countries like the U.S. and EU to streamline their approval processes in Canada.

Furthermore, Deviceology has a keen grasp of consumer needs and market trends within Canada. Our market analysis services pinpoint untapped opportunities and growing sectors—such as cardiology and orthopedic devices, which are in rising demand due to Canada’s ageing demographic.

Our holistic solutions, spanning from initial market analysis to product launch, are crafted to comply with both international and local standards. This encompasses adherence to the Canadian Medical Devices Regulations (SOR/98-282) and a nuanced understanding of Canada’s healthcare funding and policies, including both its public and private healthcare systems.

By collaborating with Deviceology, clients can expect a seamless, compliant, and well-strategised entry into Canada’s lucrative Medical Devices sector.

Japan

Deviceology excels in guiding clients through the multifaceted and promising landscape of Japan’s Medical Devices industry. Drawing on our deep-rooted expertise in international regulations and ISO standards, particularly ISO 13485 for quality management systems, we offer an array of services to ease your market entry.

Our seasoned professionals offer indispensable advice on adhering to the rigorous regulatory framework governed by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. We also provide comprehensive insights into the Japanese Pharmaceutical Affairs Law (PAL) and the Medical Device Single Audit Program (MDSAP), facilitating a more streamlined approval process for manufacturers from MDSAP-participating countries.

Japan’s Medical Devices market is noteworthy for its sophistication and growth potential. With a healthcare expenditure that is among the highest in Asia and a rapidly ageing population, Japan offers a fertile ground for medical device innovation and adoption. Our market intelligence services are finely tuned to identify these lucrative opportunities, with a focus on emerging sectors such as robotics, cardiology, and geriatric care.

Our end-to-end solutions, ranging from advanced market analysis to market entry programmes, are designed to not only meet international and Japanese regulatory standards but also to align with Japan’s unique healthcare policies and reimbursement systems.

By entering into a collaboration with Deviceology, clients can expect a seamless, compliant, and strategically advantageous foray into Japan’s highly rewarding Medical Devices market.

Deviceology is primed to assist clients in successfully entering the UK’s burgeoning Medical Devices sector. Our team of experts can help you meet the stringent MHRA regulatory requirements. Our regulatory specialists can build your Product Technical Files, identify an appropriate Notified Body, represent you at the certification audits and help you gain your UK CA marking.

Once certified, we can act as your UK Responsible Person (UKRP), support your post-market surveillance and viligiance activity, conduct your internal audits, help during annual surveillance visits and keep your product technical files up to date .

A distinct advantages of the UK market is the National Health Service (NHS), often seen as a one provider, one payer model. This simplifies procurement and allows for better market penetration. We are experts in the complexities of operating within the NHS and the pre-requisites for digital products. We can prepare your NHS Digital Technology Assessment Criteria and Data Security Toolkit submissions, help you integration with NHS APIs, and help you meet ISO27001 and ISO9001 compliance requirements.

If you’re new to the UK market or want help with ongoing regulatory obligations, please get in touch

United States

Deviceology is well-equipped to guide clients through the dynamic and expansive U.S. Medical Devices market. Utilizing our deep expertise in international regulations and ISO standards, such as ISO 13485 for quality management systems, we offer a comprehensive array of services to facilitate smooth market entry.

Our team of experts provides essential guidance on navigating the complex regulatory landscape overseen by the U.S. Food and Drug Administration (FDA). We also offer insights into the Medical Device Single Audit Program (MDSAP), which allows for a more streamlined approval process for manufacturers from MDSAP-recognized countries.

The U.S. market is particularly noteworthy for its size and growth potential. Revenue in the Medical Devices market in the United States is projected to reach $164.10 billion in 2023, with an expected annual growth rate of 4.71% from 2023 to 2028, resulting in a market volume of $206.60 billion by 2028. The largest market segment is Cardiology Devices, projected to have a market volume of $23.29 billion in 2023.

Our end-to-end solutions, from initial market research to product launch, are designed to meet both international and U.S.-specific standards. This includes a nuanced understanding of the U.S. healthcare system, reimbursement policies, and the complexities of operating across various states.

By partnering with Deviceology, clients can anticipate a streamlined, compliant, and strategically advantageous entry into the highly lucrative U.S. Medical Devices market.

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