Before any medical device can be supplied in Australia, the device must be included in the Australian Register of Therapeutic Goods (ARTG), regulated by the Australian Therapeutic Goods Administration (TGA).
The TGA uses a four-tiered classification system based on risk to the human body, with ascending risk assigned to Classes I (including sterile and measuring), IIa, IIb, and III, respectively. Like most systems, regulatory control increases with increasing risk levels. Australian classification rules are almost identical to the EU classification criteria, and classification in Australia will generally reflect that of the EU.
Companies already acquired market access in Europe will find the TGA process much easier because Australia recognizes CE Marking. Most foreign companies seeking market access in Australia already have CE Marking. However, even if the medical device or IVD has CE Marking, it must still be registered with the TGA and receive an ARTG listing number. There is also a mandatory audit for certain device classifications.
Companies without an established place of business in Australia must appoint an in-country representative, known as an Australian Sponsor. The Australian Sponsor is responsible for device registration (ARTG listing) and post-market activities, such as adverse incident reporting and recalls. The Australia Sponsor’s name and contact information must appear on the device and device label. Emergo can provide Australia Sponsor services from our office in Sydney.
With an experienced international team, Kaiyan can help you access Australia’s thriving medical device market. Our experienced consultants have experience with conformity assessments for a broad range of device types. Here’s how we can help:
China’s overall economic recovery in part has been attributed to the strong rebound in the manufacturing sector. The medical device manufacturing sector specifically recorded an astounding 46.4% growth.
Despite living in the age of automation, labor remains one of the higher costs of manufacturing. Manufacturing companies in the west have to deal with worker’s unions, paying high wages, and inflexible staffing that cannot readily scale and resize as fluctuating production output needs may require. On the other hand, achieving this flexibility level is easier for Chinese manufacturers due to China’s readily available, efficient workforce. This used to be the primary reason for companies to outsource their manufacturing activities in China.
Manufacturing in China can significantly bring down overall production costs, and a large part of those savings is due to Chinese labor efficiency. Chinese facilities have been optimizing manufacturing costs for decades and have largely achieved very efficient workforce operations. Depending on the labor intensity of product manufacturing activities, a Chinese facility can offer an excellent number of parts produced per work hour spent.
Another most important manufacturing cost is raw materials cost, for which China also provides a cost-effective option, for two main reasons. Firstly, the same labor efficiency condition exists throughout the entire raw materials production value chain. So Chinese manufacturing companies can themselves access cost-efficient raw materials than most companies based in other countries. Secondly, the transfer of materials is cheap since it only happens from close sources and within China. This results in avoiding long shipping routes, additional customs tariffs, and long delivery waiting times. When manufacturers in all industries are trying to cut expenses and maximize profits to remain competitive, access to affordable raw materials can help bring down manufacturing costs to a considerable extent.
Most Chinese manufacturing facilities will typically have low cost local (or close) material suppliers. This way, they gain a significant cost advantage that further contributes to their cost-effectiveness.
Companies worldwide are nowadays targeting the growing Asian markets, so much so that the phrase “expand to Asia” has become somewhat of a cliché business term. China is the largest of those markets, with its consumer market surpassing $6 trillion in value. Moreover, it also benefits from its proximity to several large and growing markets, such as India and South Korea. In terms of regulatory compliance, medical devices of Chinese manufacturing have no issues in being accepted in both the country’s domestic and other Asian markets. So outsourcing medical device production to China gives manufacturers access to its rapidly growing domestic market, as well as immediate access to its developing neighboring markets.
In times of market, instability is when a supply chain is a huge determining factor for a manufacturer’s chance for survival. Chinese materials suppliers have been rapidly evolving, following the country's growing trend of becoming an international manufacturing hub. This has made it easier for medical device contract manufacturers to identify and establish a trustworthy network of reliable local suppliers.
This gives the more top tier Chinese manufacturers such as Kaiyan, the opportunity to create resilience in the face of the coronavirus outbreak. Additionally, a robust supply chain allows for a manufacturer’s flexibility to offer simple, efficient, and flexible options for increasing or scaling production as market needs change. What’s also important is that this supply chain evolution has also increased quality standards, which is a decisive factor in medical device manufacturing.
Realizing the potential of its market in the era of globalization, China has spent the last decades developing its technology. Heavy investments in research and development, importing talent and technology, and the emergence of specialized tech hubs have helped China gain an innovation edge over other emerging countries. The mentality of rapid research and development is of notable importance and surpasses the speed of many tech hubs in the west. Part of the reason this happens is that such a large portion of the world’s product manufacturing has been outsourced to China. And the low costs achieved by Chinese companies are not the result of just cheap labor, but also, to an extent, involve practical applications of innovative technologies.
Another benefit of manufacturing in China is the ability to scale up or down as needs change. Top tier Chinese factories such as Kaiyan’s facilities are manufacturing products for many companies at the same facility, so they have the means to produce large quantities and adapt according to the market’s and customer’s needs. And being able to scale up easily is an obvious advantage. A critical characteristic of every trade is offering product availability. As you market your medical device to new markets, customers, importers, and distributors, you will be required to increase quantities and ensure timely delivery. Manufacturing your medical device in a Chinese facility that can support scaling up production becomes an obvious advantage.
COVID-19 has created challenges for nearly every market, and the medical device manufacturing industry is no exception. As the virus sweeps the globe, it’s becoming increasingly difficult for leaders to overcome the arising challenges and prepare for the future.
While I firmly believe the key to navigating this evolving landscape is putting quality at the forefront of all activities, a function made seamless through best of breed quality management tools, I was curious what other industry leaders had to say.
The following are some of their best tips for effectively leading and managing teams during the COVID-19 pandemic and preparing your organization for what’s to come.
Keep in touch. Let your people know where things stand with the business. At home or in the office practicing social distancing, each of your workers will be dealing with different issues, both private and professional. The distributed workforce requires even more channels to help people stay connected.
“Leadership needs to provide regular communication, be transparent about the impact of the pandemic on your company, and set expectations with your team, investors, partners, and customers. There is a great deal of uncertainty in the world, and clarity from management is one of the keys to a healthy organization.” — Paul Grand, CEO, MedTech Innovator
Be sensitive to employees’ personal situations. Every member has their own worries and family needs during this crisis. Review goals and when needed realign expectations to match current circumstances.
Balance the content. Focus on efficiency in meetings to ensure your team still has time to do their work and manage their personal situation. The recommended time for meetings should be 15 minutes with no more than 4 people per meeting
Office time should be reduced. To avoid conflicts, make sure yo manage expectations. Be clear about your expectations and the expectation from your team during these challenging times. The last thing you want to do is have misunderstandings or conflicts with a good working team.
The key purpose of a leader is to continuously motivate and support the team. Talk about work-life structures, supporting flexible working arrangements, and vocalizing empathy towards your workmates. As a leader, you must empower them to deliver their best work while being absolutely empathetic towards challenges in their life.
Focus on the fact that COVID-19 is temporary. The natural instinct may be to slow down and withdraw resources. Instead, this is an excellent time to strategically plan and dedicate time, staff, and resources to ensuring that the post-pandemic time capitalizes on key changes.
Just because you can’t conduct research the way you always have doesn’t mean you can’t conduct research at all. It is important to stay flexible with the research methods you use. Understanding the pros and cons of each method and their overall ability to contribute to your research goal is critical to conducting meaningful and useful research.
All companies are working to lead their teams through today’s challenges with confidence. By taking care of your team and keeping quality you will improve the teamwork collaboration, communication, and transparency.
Whether you’re a dermatologist, physical therapist, fitness enthusiast or just someone considering integrating light therapy into their practice, you’ve likely heard about the multitude of benefits that these non-invasive yet powerful devices offer. As light therapy continues to gain popularity, more professionals are looking for light therapy devices to level up.
Naturally, you can purchase professional devices from light therapy companies, but you can also develop a light therapy device that can be customized to fit your individual client’s needs. This is where we, Kaiyan Medical, come in to help guide you through the process of producing your very own private label light therapy products at our state-of-the-art manufacturing facility.
If you’re interested in creating your own light therapy products, it’s crucial you understand the development process.
We want our clients to comprehend the creative and manufacturing process of developing private label light therapy devices. As this is your idea we’re bringing to life, you need to be included every step of the way. Here’s our step-by-step process:
Step 1: Feasibility Study
It’s easy to lose money by investing in a product without understanding user needs. If you don’t know your target audience, you’ll struggle to create a viable product. During the feasibility step, we determine the practicality of your project and examine its strengths and weaknesses. This helps to ensure the idea you want to bring to life is viable and effective in achieving its goal.
Step 2: Industrial Design
With our advanced conceptual design team, we determine how we can best engage with your target audience. While we focus on design, we also make sure your device fits under the required safety and health regulations. Our in-house design process creates visually appealing, high-quality, and functional concepts for manufacturing and product planning.
Step 3: Electrical Engineering
Our in-house team has vast experience in lasers, sourcing, prototyping, and LEDs to incorporate these components and masterfully develop your product. Our electrical engineers, who are in charge of this step, take your idea and bring it to life while ensuring high-quality performance.
Step 4: Rapid Prototyping
Rapid prototyping is essential for our projects and allows the client to see and feel their idea in the palm of their hands. In addition, it also helps clients test products with their users and receive constructive feedback. Our rapid prototyping is completed in-house as we have the capacity to create a range of samples varying from simple to complex, multi-piece models.
Step 5: Mass Production
After your idea is turned into a tangible product and has been tested, we then plan production with in-house, pre-pilot quantities. By doing so, we’re able to identify production areas that need to be fine-tuned while ensuring high-quality and performance standards. Once these steps are completed, your product will be ready for shipment. Through our vast experience and stellar team, we can ensure a smooth manufacturing process and will guide you each step along the way, from start to finish.
We’ve been creating MDA-certified and FDA-approved light therapy devices for years. That said, we’ve successfully worked with various brands in different industries, taking their ideas and bringing them to life. Here are some of the brands and products we’ve developed.
DemarkQ
DenmarkQ offers skin care devices that use red and blue light LED to target acne and scarring. The LED light uses the body's natural healing process to improve its overall wellbeing.
Aduro Mask
Established in 2006, Aduro Skincare specializes in LED beauty-related products under a medical license. The product is internationally renowned and clinically proven as an effective, non-invasive therapeutic skin care treatment.
Perfect Countour
Perfect Contour is our line of permanent make-up machines. Our permanent make-up machines were designed for clinical use; however, we feel permanent make-up is more of an art form than a medical procedure through our experience.
Golden Eagles
Teeth whitening has been around for ages, and we've mastered the art of developing effective teeth whitening devices. We currently have over 20 different OEM models for professional whitening and devices for at-home whitening.
Akstra
Akstra's brand focuses on hair regrowth and hair rejuvenation and offers products ranging from home-use to professional-use models. Since Asktra's first line of hair lasers was made for clinical environments, we opted for a sleek and clean design.
Lumiceuticals
Lumiceuticals is a brand focusing on using LED technology for pain relief. We combined LED technology with neoprene material for practical treatment pads. The pads are secured by Velcro straps, making them easy-to-use for customers.
If you’re considering developing private label light therapy devices, at Kaiyan Medical, we create MDA-certified and FDA-approved light therapy devices, ensuring you medical-grade, high-quality devices for your business. We are eager to work with like-minded partners in developing truly effective, safe, and valuable products that tap into the power of light therapy.
We look forward to working with you!
While the world has been turned upside down, there’s one thing that’s been growing steadily with popularity: light therapy products. Perhaps you’ve tried out an infrared sauna or had an LED facial before, but haven’t dabbled in red light therapy products because of the assumed barrier to entry.
Whether it’s a light therapy face mask or a light therapy panel, these products are designed to emit red and infrared light to penetrate deeply into the skin and heal the body from the inside out. And this is why big brands are prioritizing light therapy products - they do what your skin serums and creams, and even more invasive and pharmaceutical products cannot.
Red light therapy devices are able to focus on specific parts of the body, like the face, or provide full-body healing as they treat inflammation, hair loss, arthritis, wrinkles, joint pain, wounds, and much more. Red light therapy can address root problems rather than just the symptoms, by treating conditions from the inside out.
While the global light therapy market was valued at $874 million last year, it’s expected to increase at least 5% more by 2027. The light therapy market is gaining in popularity for mental health treatment and many other physical ailments. However, the skincare industry is jumping on the opportunity to finally give customers the perfect skin they’ve been hoping for.
Dr. Dennis Gross DRx SpectraLite FaceWare Pro has gained huge recognition as 97% of users of the mask participated in a clinical study saying that it showed overall improvement in acne after 2 weeks and overall improvement in fine lines, wrinkles, skin tone, and acne after 10 weeks.
While most topical anti-aging products like creams and serums take a significant amount of time to show results, red light therapy research shows incredible results within the first couple of weeks of treatment. In addition, red light therapy products are proving to maintain long-term results without invasive and harmful procedures. Therefore, it’s a popular form of anti-aging therapy for those looking to increase collagen production and reduce fine lines and wrinkles - fast.
Consumers are looking for natural health, wellness, and anti-aging solutions without the hefty short- and long-term side effects. Another reason for red light therapy’s increasing popularity is due to its healing properties and low-cost technology. One device has the power to deliver the right amount of red and infrared light to penetrate through the body’s tissues and heal from the inside out. The technological advances in the industry improved safety and made it an affordable treatment. In addition, red light therapy treatments can be received from the comfort of one’s home, lasting an average of 10 minutes per treatment.
Celebrities are also jumping on this beauty trend, with stars like Kourtney and Khloe Kardashian using red light therapy masks as a part of their skincare routine. Kourtney Kardashian regularly uses red and blue light, with red light treating stimulating collagen production and minimizing fine lines and wrinkles, while blue light destroys acne-causing bacteria and decreases scarring.
For the first time, there’s a non-invasive, powerful skincare product on the market - and it actually works. These treatments not only produce results, but do so without investing hours per day and thousands of dollars. It’s quick, efficient, and provides long-term results.
Luckily, Kaiyan Medical produces MDA-certified and FDA-approved light therapy products and devices for your own at-home treatment or even for your patients. We've worked hard to provide solutions for both patients and healthcare practitioners, catering to various needs. Whether you're looking to private label your own light therapy devices or for home use, contact our team as we would love to help you through your light therapy journey.
