Asia Regulatory Strategy Consulting for Medical Devices

Our seasoned experts can guide your medical company through the complex regulatory pathways in Asia.

Asia Regulatory Strategy Consulting for Medical Devices

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 compliancelocal 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:

  1. 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.
  2. 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.
  3. 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.
  4. 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

Company A is a mid-sized medical company that has been experiencing rapid growth in the U.S.  They are not happy with the performance of their distributor in Japan.  Company A wants to know if they can transfer the product registrations from their current Japanese distributor to a third party entity or their own office that they could set up in Japan.  Company A asked PBM to look at the registrations for the products and provide a strategy to have more control over their products in Japan in the future.  PBM’s regulatory team in Tokyo researched the situation and provided different options, listing out the pros and cons, costs, and timelines for each option.

Regulatory Strategy Project Example: Korea

Company B is an IVD manufacturer in the U.S.  Company B is currently working with their distributor in South Korea to register several of their IVD products with Korea’s Ministry of Food and Drug Safety (MFDS). Their Korean distributor says the MFDS is requesting a great amount of proprietary information as part of a supplementary request. Company B asked PBM to look at the supplementary request (in Korean) and the initial submissions to determine which information is necessary to submit and which information does not need to be submitted for approval.

Regulatory Strategy Project Example: China

Company C is a large international company that sells consumer goods, including beauty/health products for home use. When Company C develops a new prototype for a beauty/health product that may have some medical claims, PBM investigates the regulatory pathway for the product in China so that Company C can plan ahead. PBM’s China team (regulatory experts, marketing experts, etc.) do the primary research on the ground from our office in China to write a comprehensive regulatory strategy report. PBM’s regulatory strategy reports often influence Company C’s product development plans for China.  For example, if PBM finds that Company C’s prototype product will be classified as a Class III medical device in China, then Company C may reduce their claims so that the product has a better chance to be classified as a low risk or non-medical device in China.

Regulatory Strategy Project Example: Taiwan

Company D is an international medical device company that is interested in selling a few of their innovative new devices in Taiwan. Company D asked PBM to investigate the registration pathway and requirements for their devices in Taiwan so they can determine whether or not to enter the Taiwanese market now or later. PBM found that because their devices are considered brand new technology in Taiwan, they will need to go through the very arduous pre-market approval (PMA) registration route. PBM’s Taiwan regulatory team compared the PMA requirements with the foreign safety and efficacy data that Company D already had.  PBM recommended to start by registering only one of the new devices which had the best chance of being successfully registered in Taiwan.

Regulatory Strategy Project Example: Southeast Asia

Company E is a medical company that manufactures technology for dialysis. Some of their products have both device and drug components. Company E is moving the manufacturing of the drug component from Europe to China. They asked PBM to research all the implications this manufacturing change would have on their existing and future registrations in the ASEAN countries. PBM researched the regulatory situation in each ASEAN country and then provided Company E with a detailed strategy report and answered all of Company E’s follow up questions.

Regulatory Strategy Project Examples: Multiple Asian Markets

Project Example #1:
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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