Ofer Tirosh, CEO & Founder, Tomedes06.05.23
China is considered one of the largest manufacturing hubs for medical devices in the world, supplying various types of medical devices to many countries. It is estimated that the China medical devices market will have an annual growth of 6% by 2030, and this is due in part to its large population and significant investments and tax incentives from the government made in their healthcare sector, especially for clinics and hospitals.
If you want to learn more about China's medical device regulations and how you can penetrate this market effectively, keep reading!
The NMPA classifies China medical devices into three categories: Class I, Class II, and Class III, based on the level of risk the medical device poses. The classification of a medical device determines the regulatory requirements that a company needs to meet to get it approved for the Chinese market. The higher the risk classification, the more stringent the regulatory requirements.
Before any medical device can be sold in the Chinese market, it must go through a pre-market approval process. This involves submitting an application to the NMPA for review and submitting information about the medical device, like its quality, efficacy, and safety. Part of the evaluation will include the manufacturing process and labeling of the medical product, which the NMPA will conduct on-site inspections or request for additional information. After the NMPA deems that the medical device meets all requirements, it will provide a registration certification that will allow the China medical device to be sold.
1. Understand the Chinese Market
Before entering the Chinese medical device market, it's important to understand the local market landscape, including cultural and linguistic considerations, competitor analysis, and target audience analysis.
China has a unique cultural and linguistic landscape. For example, in the healthcare system in China, about 95% of patients have public health insurance compared to the US whose citizens have private insurance covering their medical needs. This might not seem much but it can affect your approach to medical device localization marketing and the development of your product.
You will also have to consider the language for labeling and the user experience of your Chinese customers. You will have to work with language professionals, Chinese marketing experts, or a translation company to ensure that your localized medical device is accurate and based on the cultural preference of your customers.
By researching the Chinese market, you can better identify the market gaps and the areas where your competitors are lacking. Analyzing your competitors and target audience can make your pricing, production, marketing, and distribution plans more align with your customer's needs, which can lead to better market penetration in China.
2. Develop a Medical Device Localization Strategy
In the previous article that I wrote about market penetration in France, I discussed how language and culture play a significant role in the successful expansion into a new market. And so, you will have to develop a medical device localization strategy that involves adapting your medical devices to your target audience's local regulations and cultural and linguistic preferences.
The first step in developing a medical device localization strategy is to define localization goals and have a timeline for when you should be able to accomplish them. For example, within six months, you must have compiled all the documents required for NMPA registration, get the classification for your devices, and have a certificate to sell them in China.
Part of your plans can also include the budget for localizing the product and the costs involved in working with overseas manufacturers, marketing, and translation.
In developing a strategy, you must make cultural adaptations in your medical device localization so that its features, design, and marketing messages meet local cultural norms and preferences.
As mentioned, the majority in China uses public health care insurance. You can work with local public officials to promote and integrate products in hospitals and clinics.
3. Conduct Thorough Research on Medical Device Registration China Localization
Navigating the regulatory approval process in China can be challenging and time-consuming. The approval process involves several stages: product testing, clinical trials, and regulatory review.
Conducting thorough research on medical device registration and localization in China is crucial for companies looking to enter the Chinese market. China's regulatory landscape can be complex and challenging, particularly for new companies. It's essential to have a comprehensive understanding of China's regulatory landscape, including the roles and responsibilities of key regulatory bodies, such as the National Medical Products Administration (NMPA).
Companies must also know relevant China medical device regulations and guidelines, such as the Medical Device Classification Catalogue. By understanding the regulatory landscape, companies can ensure that their products meet all requirements and avoid costly delays or compliance issues.
4. Working with Various Professionals and Experts on Medical Device Localization
When localizing medical devices for the Chinese market working with various experts, such as translation companies, legal professionals, and marketing consultants, can be beneficial to ensure quality when localizing your medical devices for the Chinese market.
Another consideration is partnering with local pharmaceutical companies, clinics, and hospitals. Clear communication and collaboration are also essential for successful partnerships. Companies should establish clear expectations and timelines, maintain open communication throughout the project, and ensure all parties are aligned on project goals and requirements.
5. Implement an Effective Plan for Project Management
Project management plays a critical role in ensuring the success of medical device localization projects. Effective project management helps to ensure that projects are delivered on time, within budget, and to the required quality standards. This helps to minimize the risk of delays or issues during the localization process.
Several key considerations must be considered when implementing a project management plan for medical device localization. These may include:
6. Develop High-Quality Content
High-quality content is critical to the success of medical device localization projects. Quality content helps to ensure that the product is accurately and effectively communicated to the target audience, which is essential for building trust and credibility.
You can take several steps to ensure that their content is accurate and consistent, such as:
7. Test and Validate Localization
Testing and validation are critical to ensure that medical devices meet the target audience's needs and comply with relevant regulations and guidelines. It helps ensure the product is safe, effective, and user-friendly. It can also help you identify potential issues and make necessary improvements before launching the product in the Chinese market.
Several types of testing and validation may be required for medical device localization, such as usability testing, functionality testing, and clinical testing.
Usability testing involves testing the product with users to ensure it is easy to use and understand. Functionality testing involves testing the product's features and functions to ensure they work correctly. Clinical testing involves testing the product's safety and effectiveness in a clinical setting. Successful testing and validation require careful planning and execution.
Your medical device localization strategy must coincide with the results from these tests and adapt to the needs of your Chinese consumers.
8. Plan for Ongoing Maintenance and Support for Overseas Manufacturing
After a medical device is successfully localized and launched in China, you must have ongoing maintenance and support to ensure that the device operates optimally and remains compliant with local regulations. It involves developing a comprehensive maintenance and support plan that outlines the roles and responsibilities of all stakeholders involved in the device's manufacturing and distribution.
It is essential to establish clear communication channels and protocols between all stakeholders. You can create a customer support system that is more accessible to end-users in China. Additionally, regular product testing, training, and documentation updates are necessary to maintain compliance with local regulations.
You will need to gather and analyze feedback from end-users and other stakeholders in the Chinese market. From the feedback, you can identify areas for improvement and implement corrective actions to enhance the device's functionality and performance.
9. Embrace Flexibility and Adaptability
Localization is a dynamic process that requires flexibility and adaptability to succeed in the Chinese market. This involves being receptive to changes in market conditions, regulatory requirements, and customer preferences.
Regular market research to identify emerging trends and customer needs, like through focus groups, surveys, and other market research methods, will make your China medical device more appealing to local consumers. Additionally, it is essential to establish a feedback loop with end-users to gather insights into the device's performance and identify areas for improvement.
This can be achieved by fostering a culture of innovation within the organization and partnering with research institutions and other industry stakeholders to develop new technologies and products.
10. Measure and Analyze Success
Lastly, measuring and analyzing the success of a medical device localization project in China is critical to understanding the localization strategy's effectiveness and identifying improvement opportunities. It will involve defining clear success metrics aligning with the localization goals and tracking progress against them.
Key performance indicators (KPIs) that can measure localization success include revenue growth, market share, customer satisfaction, and compliance with local regulations. Additionally, it is essential to track metrics related to the translation and localization process, such as translation accuracy and efficiency. As mentioned, having a feedback loop ensures that your China medical device market penetration and development objectives are met.
In 2007, Ofer Tirosh founded Tomedes, a translation company dedicated to offering the best multilingual and technological solutions to businesses worldwide. As the CEO and founder of Tomedes, he has managed several projects in the healthcare and medical field such as software localization, translating medical documents, providing marketing insights, and translating legal certificates and documents for international compliance and local regulatory requirements.
If you want to learn more about China's medical device regulations and how you can penetrate this market effectively, keep reading!
Understanding Chinese Regulatory Bodies
In 2013, China Food and Drug Administration (CFDA) regulated safety and evaluated the quality of food, medical devices, and drugs. However, it later became the National Medical Products Administration (NMPA), wherein businesses can register their medical device and have their products inspected in compliance with China medical device regulations.The NMPA classifies China medical devices into three categories: Class I, Class II, and Class III, based on the level of risk the medical device poses. The classification of a medical device determines the regulatory requirements that a company needs to meet to get it approved for the Chinese market. The higher the risk classification, the more stringent the regulatory requirements.
Before any medical device can be sold in the Chinese market, it must go through a pre-market approval process. This involves submitting an application to the NMPA for review and submitting information about the medical device, like its quality, efficacy, and safety. Part of the evaluation will include the manufacturing process and labeling of the medical product, which the NMPA will conduct on-site inspections or request for additional information. After the NMPA deems that the medical device meets all requirements, it will provide a registration certification that will allow the China medical device to be sold.
A Translation Expert's Insight on Medical Device Localization in China
Since I founded my translation company in 2007, I have handled several projects on China medical device localization. From my experience working in the field of translation and localization for more than a decade, I have listed below some tips and advice on what you can do to get started localizing your medical device for the China medical industry solutions:1. Understand the Chinese Market
Before entering the Chinese medical device market, it's important to understand the local market landscape, including cultural and linguistic considerations, competitor analysis, and target audience analysis.
China has a unique cultural and linguistic landscape. For example, in the healthcare system in China, about 95% of patients have public health insurance compared to the US whose citizens have private insurance covering their medical needs. This might not seem much but it can affect your approach to medical device localization marketing and the development of your product.
You will also have to consider the language for labeling and the user experience of your Chinese customers. You will have to work with language professionals, Chinese marketing experts, or a translation company to ensure that your localized medical device is accurate and based on the cultural preference of your customers.
By researching the Chinese market, you can better identify the market gaps and the areas where your competitors are lacking. Analyzing your competitors and target audience can make your pricing, production, marketing, and distribution plans more align with your customer's needs, which can lead to better market penetration in China.
2. Develop a Medical Device Localization Strategy
In the previous article that I wrote about market penetration in France, I discussed how language and culture play a significant role in the successful expansion into a new market. And so, you will have to develop a medical device localization strategy that involves adapting your medical devices to your target audience's local regulations and cultural and linguistic preferences.
The first step in developing a medical device localization strategy is to define localization goals and have a timeline for when you should be able to accomplish them. For example, within six months, you must have compiled all the documents required for NMPA registration, get the classification for your devices, and have a certificate to sell them in China.
Part of your plans can also include the budget for localizing the product and the costs involved in working with overseas manufacturers, marketing, and translation.
In developing a strategy, you must make cultural adaptations in your medical device localization so that its features, design, and marketing messages meet local cultural norms and preferences.
As mentioned, the majority in China uses public health care insurance. You can work with local public officials to promote and integrate products in hospitals and clinics.
3. Conduct Thorough Research on Medical Device Registration China Localization
Navigating the regulatory approval process in China can be challenging and time-consuming. The approval process involves several stages: product testing, clinical trials, and regulatory review.
Conducting thorough research on medical device registration and localization in China is crucial for companies looking to enter the Chinese market. China's regulatory landscape can be complex and challenging, particularly for new companies. It's essential to have a comprehensive understanding of China's regulatory landscape, including the roles and responsibilities of key regulatory bodies, such as the National Medical Products Administration (NMPA).
Companies must also know relevant China medical device regulations and guidelines, such as the Medical Device Classification Catalogue. By understanding the regulatory landscape, companies can ensure that their products meet all requirements and avoid costly delays or compliance issues.
4. Working with Various Professionals and Experts on Medical Device Localization
When localizing medical devices for the Chinese market working with various experts, such as translation companies, legal professionals, and marketing consultants, can be beneficial to ensure quality when localizing your medical devices for the Chinese market.
Another consideration is partnering with local pharmaceutical companies, clinics, and hospitals. Clear communication and collaboration are also essential for successful partnerships. Companies should establish clear expectations and timelines, maintain open communication throughout the project, and ensure all parties are aligned on project goals and requirements.
5. Implement an Effective Plan for Project Management
Project management plays a critical role in ensuring the success of medical device localization projects. Effective project management helps to ensure that projects are delivered on time, within budget, and to the required quality standards. This helps to minimize the risk of delays or issues during the localization process.
Several key considerations must be considered when implementing a project management plan for medical device localization. These may include:
- Establishing clear project goals and timelines
- Identifying key stakeholders and team members
- Defining project roles and responsibilities
- Setting up effective communication and collaboration channels
- Tracking project progress and identifying potential issues
- Conducting regular project reviews and evaluations
6. Develop High-Quality Content
High-quality content is critical to the success of medical device localization projects. Quality content helps to ensure that the product is accurately and effectively communicated to the target audience, which is essential for building trust and credibility.
You can take several steps to ensure that their content is accurate and consistent, such as:
- Working with qualified translators and editors
- Developing and using style guides and glossaries
- Using translation memory tools to ensure consistency across all content
- Conducting regular reviews and evaluations of content to ensure accuracy and consistency
7. Test and Validate Localization
Testing and validation are critical to ensure that medical devices meet the target audience's needs and comply with relevant regulations and guidelines. It helps ensure the product is safe, effective, and user-friendly. It can also help you identify potential issues and make necessary improvements before launching the product in the Chinese market.
Several types of testing and validation may be required for medical device localization, such as usability testing, functionality testing, and clinical testing.
Usability testing involves testing the product with users to ensure it is easy to use and understand. Functionality testing involves testing the product's features and functions to ensure they work correctly. Clinical testing involves testing the product's safety and effectiveness in a clinical setting. Successful testing and validation require careful planning and execution.
Your medical device localization strategy must coincide with the results from these tests and adapt to the needs of your Chinese consumers.
8. Plan for Ongoing Maintenance and Support for Overseas Manufacturing
After a medical device is successfully localized and launched in China, you must have ongoing maintenance and support to ensure that the device operates optimally and remains compliant with local regulations. It involves developing a comprehensive maintenance and support plan that outlines the roles and responsibilities of all stakeholders involved in the device's manufacturing and distribution.
It is essential to establish clear communication channels and protocols between all stakeholders. You can create a customer support system that is more accessible to end-users in China. Additionally, regular product testing, training, and documentation updates are necessary to maintain compliance with local regulations.
You will need to gather and analyze feedback from end-users and other stakeholders in the Chinese market. From the feedback, you can identify areas for improvement and implement corrective actions to enhance the device's functionality and performance.
9. Embrace Flexibility and Adaptability
Localization is a dynamic process that requires flexibility and adaptability to succeed in the Chinese market. This involves being receptive to changes in market conditions, regulatory requirements, and customer preferences.
Regular market research to identify emerging trends and customer needs, like through focus groups, surveys, and other market research methods, will make your China medical device more appealing to local consumers. Additionally, it is essential to establish a feedback loop with end-users to gather insights into the device's performance and identify areas for improvement.
This can be achieved by fostering a culture of innovation within the organization and partnering with research institutions and other industry stakeholders to develop new technologies and products.
10. Measure and Analyze Success
Lastly, measuring and analyzing the success of a medical device localization project in China is critical to understanding the localization strategy's effectiveness and identifying improvement opportunities. It will involve defining clear success metrics aligning with the localization goals and tracking progress against them.
Key performance indicators (KPIs) that can measure localization success include revenue growth, market share, customer satisfaction, and compliance with local regulations. Additionally, it is essential to track metrics related to the translation and localization process, such as translation accuracy and efficiency. As mentioned, having a feedback loop ensures that your China medical device market penetration and development objectives are met.
In 2007, Ofer Tirosh founded Tomedes, a translation company dedicated to offering the best multilingual and technological solutions to businesses worldwide. As the CEO and founder of Tomedes, he has managed several projects in the healthcare and medical field such as software localization, translating medical documents, providing marketing insights, and translating legal certificates and documents for international compliance and local regulatory requirements.