Bryan Gilburg - China

“With an average of 25 years experience, Asia Actual’s clients have direct access to the best regulatory consultants in the region.”

Bryan Gilburg

Managing Director

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Asia Actual is the Best Medical Device Regulatory Consulting Company in Asia

Published on: February 23th, 2022

Who We Are

Asia Actual is a medical device regulatory consulting firm that specializes in helping medical device manufacturers navigate the complex regulatory landscape in Asia. With an average of 25 years in the medical device industry, our clients have direct access to the most experienced consultants in each market providing you with expert guidance and support in regulatory compliance, market access, product registration, quality management, and post-market surveillance.

Asia Actual has a team of experienced regulatory consultants located in key markets in Asia, including China, Japan, Korea, and Southeast Asia, who have a deep understanding of local regulations and can provide customized solutions to meet the unique needs of each client.

We also play an important role as an independent license holder allowing manufacturers to maintain ownership over their market access. By using an independent license holder, medical device companies can expand their reach in Asia and gain access to new markets without giving leverage to distributors or investing in a local office and personnel.

As the top independent license holder in India, Thailand, Philippines, and Indonesia, Asia Actual holds over 1,200 medical device licenses throughout the region. Some of our clients can be found here.

By The Numbers

Asia Actual is the preeminent regulatory medical device consulting company in Asia. Here are some numbers to back it up.

Asia Actual:

  1. Holds over 1,100 active licenses throughout the region,
  2. Provides local partnership services to over 200 medical device manufacturers,
  3. Has registered over 100 innovative medical devices,
  4. Works with over 20 publicly traded companies,
  5. Employs over 10 experts with over 20 years of medical device regulatory experience.

Why You Should Work with Asia Actual

In the highly regulated and rapidly evolving field of medical devices, navigating the regulatory landscape in Asia is a challenging task. To ensure that medical devices comply with the regulations of each country they are intended to be sold in, it is crucial to work with experienced and knowledgeable medical device regulatory consultants. Furthermore, the importance of independent license holding cannot be overstated. In many Asian countries, local regulations require medical device companies to have an independent, in-country license holder in order to import, distribute, or sell medical devices. By using an independent license holder, manufacturers can work with as many distributors as they want and can guarantee they won’t lose access to the market.

In Asia, each country has its own regulatory framework for medical devices, with different rules, requirements, and timelines. While many southeast Asian markets have harmonized their regulations with the ASEAN Medical Device Directive (ASEAN MDD), there are still significant variations between member countries. For instance, many countries have different classifications and rules for medical devices, which can impact the regulatory pathway and requirements for registration.

What We Can Do for You

Asia Actual’s medical device regulatory consultants can help manufacturers and importers navigate the complex regulatory process by providing expert guidance and support in the following ways:

  1. Understanding the regulatory landscape: With an average of 25 years of experience, our regulatory consultants are knowledgeable about the latest regulations, guidance, and policies in each country, and can help companies stay up-to-date with the latest changes.
  2. Developing regulatory strategies: We can help you develop a regulatory strategy that takes into account the unique regulatory requirements of each country, the intended use of the device, and the company’s goals.
  3. Preparing regulatory submissions: We can assist you with preparing the necessary documentation for regulatory submissions, including technical files, test reports, and clinical data.
  4. Navigating the review process: We can help you navigate the review process by communicating with regulatory authorities, addressing any questions or concerns they may have, and helping to expedite the process when possible.
  5. Independent license holding: Allows you to maintain control over your license and market access while making it easier to work with as many distributors as you want.
  6. Post-market compliance: We can ensure you maintain compliance with post-market requirements, such as adverse event reporting and product labeling updates.
  7. Outsourced regulatory support: We can help you manage fluctuations in regulatory work without needing to hire additional staff for short term needs.

Save Time and Money Without Sacrificing Quality

In addition to helping companies comply with regulations, we also help save time and money by avoiding costly mistakes and delays in the regulatory process. By working with our experienced regulatory consultants, medical device companies can ensure that their products are compliant with regulations and are safely marketed in the target markets in Asia.

Contact Asia Actual today to learn more about how we can help you grow your sales in Asia.

Competent Authorities We Work With

Asia Actual has extensive medical device regulatory consulting experience working with the following Competent Authories and has provided expedited market access to hunders of medical device manufacturers.

  1. China – National Medical Products Administration (NMPA) – http://english.nmpa.gov.cn/
  2. India – Central Drugs Standard Control Organization (CDSCO) – https://cdsco.gov.in/
  3. Japan – Pharmaceuticals and Medical Devices Agency (PMDA) – https://www.pmda.go.jp/english/
  4. South Korea – Ministry of Food and Drug Safety (MFDS) – http://www.mfds.go.kr/eng/
  5. Taiwan – Food and Drug Administration (TFDA) – https://www.fda.gov.tw/EN/
  6. Singapore – Health Sciences Authority (HSA) – https://www.hsa.gov.sg/
  7. Malaysia – Medical Device Authority (MDA) – https://www.mda.gov.my/
  8. Indonesia – National Ministry of Health (MOH) – https://www.kemkes.go.id/index.php?lg=ln02
  9. Thailand – Food and Drug Administration (FDA) – https://www.fda.moph.go.th/index.php/en/
  10. Vietnam – Ministry of Health (MOH) – https://moh.gov.vn/web/ministry-of-health
  11. Hong Kong – Medical Device Division (MDD) – https://www.mdd.gov.hk/en/home/index.html
  12. Philippines – Philippines Food and Drug Admistration (PFDA) – https://www.fda.gov.ph/
  13. Australia – Australian Therapeutics Goods Administration (TGA) – https://www.tga.gov.au/
  14. Russia – Russia’s Federal Service for Surveillance in Healthcare – https://roszdravnadzor.gov.ru/en

Come Grow With Us

Please contact us if you’d like to lean more about our medical device regulatory consulting services and support entering the Asian medical device market. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.

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