Our seasoned experts can guide your medical company through the complex regulatory pathways in Asia.
The regulatory process from product design to market entry for a new medical device or IVD is oftentimes complicated and unclear. In Asia, it can also become difficult to make a clear distinction between your regulatory strategy and business strategy. For example, if your international sales and marketing executive signs agreements with distributors who lack expertise on the local regulatory approval process, registering and selling your medical products could become a very challenging process.
Pacific Bridge Medical (PBM)’s Asia medical device consulting services can help your medical company develop an intelligent, effective strategy to obtain product registration approval and access the medical markets in your targeted Asian countries. Our robust knowledge of Asia’s medical device regulations and effective strategic plans have assisted numerous clients with proactively eliminating risks and uncertainty, while maximizing the potential for commercial success. We work closely with our clients to solve their most complex regulatory problems in areas such as product registration, reimbursement, quality compliance, local agent representation, and clinical trials.
There are several key factors that should be considered when developing a regulatory strategy for your medical device product in Asia:
- Does your regulatory strategy include consideration of the constantly changing regulatory environment in the Asia markets?
New medical device regulations and approval requirements are released on a regular basis. We are always keeping track of these updates so that you can be caught up immediately. What products can be classified as medical devices or in vitro diagnostics according to the official definition? What documents are required to be submitted? Whose name can a foreign medical company register their medical product under? We have the answers to all these questions and more.
- Does your regulatory strategy proactively identify challenges or issues that may delay approval of your medical device?
Not only will we pinpoint potential obstacles so that you can avoid any unexpected roadblocks during the registration process, our regulatory consultants will help you define innovative solutions and approaches to circumvent these challenges ahead of time.
- Does your regulatory strategy identify the most cost-effective way to get your medical product registered?
For example, can foreign clinical data be used for product registration or are there local clinical trials required? If they are required, is your local partner willing to assist with the associated costs? We can help you assess the fastest and most efficient registration pathway for your medical product.
- Does your regulatory strategy correctly identify the key success measures to obtain product reimbursement?
Obtaining reimbursement status is essential for your sales performance in Asia; however, the process can be complicated. Our experts have the knowledge and experience with official reimbursement procedures necessary to procure a competitive price for your medical product.
Pacific Bridge Medical’s Asia medical consulting is your finger on the pulse of Asia’s booming medical device industries. Our expert consultants have assisted many of our international clients with identifying efficient, actionable strategies for product classification, registration, and reimbursement.
We specialize in complex projects that require innovative strategic thinking and deep industry knowledge. To read about specific examples of regulatory strategy projects that we have successfully completed for our clients in the past, please select a target market below. Companies interested in introducing their medical devices or expanding their business into Asia can contact us for guidance on developing a successful regulatory strategy.
Regulatory Strategy Project Example: Japan
Regulatory Strategy Project Example: Korea
Regulatory Strategy Project Example: China
Regulatory Strategy Project Example: Taiwan
Regulatory Strategy Project Example: Southeast Asia
Regulatory Strategy Project Examples: Multiple Asian Markets
Company F is a mid-size medical device company in the U.S. with a device that is a delivery system for a drug. Company F would like to start selling in the Asian markets. They asked PBM to determine the best regulatory strategy in all the Asian markets for their product. For an intense 3-week period, PBM’s project managers in the U.S. worked with our regulatory experts on the ground in each local Asian country to answer the following questions:
- What is the regulatory classification/registration pathway for Company F’s product in each Asian country? Is the product regulated as a device, drug, or both?
- What are the document requirements, costs, and timelines for each registration scenario?
- Is the drug that is used with the device already approved in each Asian country for the same indication/dosage/form? If not, can physicians prescribe the device/drug off label?
- Are there specific regulatory hurdles that Company F can address now? For example, in some Asian countries there is a Country of Origin requirement for registration. If the device is manufactured in the U.S. but is only approved in Europe, can Company F move some manufacturing steps to Europe in order to have Country of Origin approval?
- Which Asian countries should Company F move forward in first?
Project Example #2:
Company G is a large international device company that is interested in acquiring Company H (another device company) in the near future. Company G asked PBM to conduct regulatory due diligence on Company H’s products in the Asian markets. PBM worked with our local people on the ground in Asia to research Company H’s product registrations in each Asian country and provided our input on necessary post-acquisition measures.
Our Asia-focused consultants possess the experience and expertise to help Western companies succeed in the Asian medical markets. With our knowledge of the Asian medical device industry and its regulations, we can help your company achieve approval for your device in the Asian countries. Contact us for a free consultation regarding your specific needs.
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