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 US Agent and Representation services provider for foreign medical device manufacturers seeking to enter the US market. They offer a physical US presence and manage critical regulatory communications and processes with the FDA.
**Expertise & scope**
* Serves as the FDA US Agent, maintaining a US place of business (not a PO Box) and ensuring availability during normal business hours for FDA communication and inspections.
* Manages FDA establishment registration and listing processes for foreign manufacturers.
* Acts as an FDA Initial Importer, facilitating the marketing of Class I and Class II devices from export to the point of final sale in the US.
* Responsible for reporting adverse events (under 21 CFR 803 Medical Device Reporting regulations), specific malfunctions, Corrections and Removals, and Medical Device Tracking.
* Maintains an MDR event file for each adverse event.
* Offers different levels of US establishment presence, from a branded office to a fully staffed office.
**Reputation / proof points**
* Offers a branded US office option for enhanced market presence.
Asia Actual, LLC is a US Agent and Representation services provider for foreign medical device manufacturers seeking to enter the US market. They offer a physical US presence and manage critical regulatory communications and processes with the FDA.
**Expertise & scope**
* Serves as the FDA US Agent, maintaining a US place of business (not a PO Box) and ensuring availability during normal business hours for FDA communication and inspections.
* Manages FDA establishment registration and listing processes for foreign manufacturers.
* Acts as an FDA Initial Importer, facilitating the marketing of Class I and Class II devices from export to the point of final sale in the US.
* Responsible for reporting adverse events (under 21 CFR 803 Medical Device Reporting regulations), specific malfunctions, Corrections and Removals, and Medical Device Tracking.
* Maintains an MDR event file for each adverse event.
* Offers different levels of US establishment presence, from a branded office to a fully staffed office.
**Reputation / proof points**
* Offers a branded US office option for enhanced market presence.
Additional information
Asia Actual, LLC provides a physical US office to fulfill the FDA's requirement for foreign manufacturers to appoint a US Agent. This presence is crucial for managing communications with the FDA, including answering inquiries about imported devices and facilitating scheduled inspections. Beyond the basic US Agent role, they also act as an Initial Importer, which involves managing the supply chain to the final point of sale and reporting adverse events. This dual role can streamline market entry by providing a single point of contact for both regulatory representation and initial import responsibilities. They offer tiered US establishment options to suit different market entry strategies.
Key Highlights
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Acts as FDA US Agent, maintaining a physical US place of business for communication and inspections.
Source
“Asia Actual will maintain a place of business in the US (PO boxes not permitted) and remain available to answer the phone during normal business hours.”
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Serves as an FDA Initial Importer, facilitating device marketing and managing adverse event reporting.
Source
“As Initial Importers, we are subject to FDA inspection and are responsible for reporting adverse events to both you and the FDA.”
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Manages FDA establishment registration and listing processes for foreign clients.
Source
“Asia Actual will manage the payment, registration and listing process on behalf of clients for US Agent services.”
Certifications & Trust Signals
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Offers various branded US establishment options, including a branded office.
Source
“Branded US Establishment Options; Level 1: Branded Office”
Buyer Snapshot
Best for
- Foreign medical device manufacturers needing an FDA US Agent.
- Companies requiring an Initial Importer for US market entry.
- Manufacturers seeking a physical US presence for regulatory compliance.
How engagement typically works
- Provides a physical US office for regulatory representation.
- Manages FDA communications and reporting.
- Facilitates device marketing and initial import.
Typical deliverables
- FDA US Agent services
- Establishment registration and listing
- Initial Importer services
- Adverse event reporting
- US office presence
Good to know
- Best when requiring a physical US address for FDA registration.
- Best when needing a partner to manage adverse event reporting.
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 range.
“Americas Actual US Agent Fee: $750 per year”
HQ:
Austin, US
Languages:
English
Timezones:
UTC-6, UTC-5
Claim status:
Listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Registration Support:
Yes
Product Type:
devices
Recall Support:
Yes
Inspection Support:
Yes
Emergency Contact24x7:
No
Additional us_agent_fda Details
Product Types
medical devices
Registration Support
Yes
Recall Support
Yes
Inspection Support
Yes
Emergency Contact24x7
No
Onboarding Steps
The first step involves understanding the product's position and assessing preparedness for US market entry, followed by a free consultation.
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