Asia Actual, LLC
Asia Actual provides expert medical device regulatory and market access consulting for Asian markets. They help manufacturers navigate complex registration processes and accelerate time to revenue.
Asia Actual specializes in assisting medical device manufacturers in gaining and maintaining access to dynamic Asian markets. With offices staffed by experienced, bilingual regulatory and market access professionals in major Asian capital cities, they offer comprehensive support for device registration, post-market vigilance, importing, and commercialization. Their services are designed to simplify the registration process and accelerate your time to revenue across various Asian countries, including Australia, China, India, Japan, Malaysia, Philippines, Singapore, and more. Asia Actual distinguishes itself through outstanding personnel, clear communication, and transparent operations, making them a premier option for market access solutions in the region. They offer tailored guidance on specific regulatory requirements, such as MAH responsibilities in Sri Lanka, fast-track pathways in the UK and Singapore, and navigating regulations in the Philippines and Malaysia. Contact Asia Actual for a free consultation to explore your market access options in Asia.
About
**Who they are**
Asia Actual, LLC is a U.S. Agent and representation service provider focused on assisting foreign medical device manufacturers with navigating the U.S. market and FDA regulations.
**Expertise & scope**
* Serves as a U.S. Agent to manage communication with the FDA for foreign manufacturers.
* Maintains a physical place of business in the U.S. as required by the FDA.
* Assists with FDA establishment registration and listing processes.
* Acts as an FDA Initial Importer, facilitating the marketing of Class I and Class II devices.
* Responsible for reporting adverse events, malfunctions, corrections, and removals to the FDA.
* Maintains MDR event files for each adverse event.
* Offers branded U.S. Establishment options, including a branded office, sales & marketing support, and a fully staffed office.
**Reputation / proof points**
* Offers a free 30-minute consultation to assess product position and U.S. market entry preparedness.
Asia Actual, LLC is a U.S. Agent and representation service provider focused on assisting foreign medical device manufacturers with navigating the U.S. market and FDA regulations.
**Expertise & scope**
* Serves as a U.S. Agent to manage communication with the FDA for foreign manufacturers.
* Maintains a physical place of business in the U.S. as required by the FDA.
* Assists with FDA establishment registration and listing processes.
* Acts as an FDA Initial Importer, facilitating the marketing of Class I and Class II devices.
* Responsible for reporting adverse events, malfunctions, corrections, and removals to the FDA.
* Maintains MDR event files for each adverse event.
* Offers branded U.S. Establishment options, including a branded office, sales & marketing support, and a fully staffed office.
**Reputation / proof points**
* Offers a free 30-minute consultation to assess product position and U.S. market entry preparedness.
Additional information
Asia Actual, LLC provides tiered U.S. Establishment options to enhance a foreign manufacturer's presence in the U.S. market. These options range from a basic branded office to a fully staffed operation, allowing companies to scale their U.S. footprint as needed. As an Initial Importer, they are subject to FDA inspections and play a crucial role in the post-market surveillance of devices, including the reporting of adverse events. Their services are designed to streamline the process for foreign entities seeking to sell medical devices in the United States.
Key Highlights
-
Asia Actual, LLC provides U.S. Agent and Representation Services for foreign medical device manufacturers.
Source
“Americas Actual US Agent Fee: $750 per year”
-
Offers tiered U.S. Establishment options: Branded Office, Sales & Marketing, and Fully Staffed Office.
Source
“Branded US Establishment Options; Level 1: Branded Office; Level 2: Sales & Marketing; Level 3: Fully Staffed Office”
-
Acts as an FDA Initial Importer, responsible for reporting adverse events and facilitating device marketing.
Source
“As Initial Importers, we are subject to FDA inspection and are responsible for reporting adverse events to both you and the FDA.”
Certifications & Trust Signals
-
Offers a free 30-minute consultation to assess U.S. market entry preparedness.
Source
“Please tell us more about your current situation and link to your product and we can provide you with a free 30 minute consultation.”
Buyer Snapshot
Best for
- Foreign medical device manufacturers seeking FDA U.S. Agent services.
- Companies needing assistance with FDA establishment registration and device listing.
- Businesses looking for an Initial Importer to facilitate U.S. market entry.
How engagement typically works
- Consultative approach with a free initial assessment.
- Provides tiered service levels for U.S. representation.
- Manages FDA communication and regulatory processes.
Typical deliverables
- FDA U.S. Agent designation.
- Establishment registration and listing management.
- Adverse event reporting and MDR file maintenance.
- Facilitation of device marketing within the U.S.
Good to know
- Best when engaging with foreign manufacturers of Class I and Class II medical devices.
- Requires a physical U.S. presence, not just a P.O. Box.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: $750 per year for US Agent services
Notes:
Pricing for other services like Sales & Marketing or Fully Staffed Office is not explicitly detailed as a yearly fee but other figures like $5,236 and $3,000 per year are mentioned in relation to pricing. Final fees depend on scope.
“Americas Actual US Agent Fee: $750 per year”
HQ:
Austin, US
Languages:
English
Timezones:
UTC-6, UTC-5
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Registration Support:
Yes
Product Type:
devices
Additional us_agent_fda Details
Product Types
Medical Devices (Class I, Class II)
Registration Support
Yes
Recall Support
Yes (via adverse event reporting)
Inspection Support
Yes
Emergency Contact24x7
No
Onboarding Steps
Initial consultation to assess product position and market entry preparedness.
