Qualtech Consulting Corporation Pty Ltd
Qualtech Consulting Corporation offers expert regulatory consulting and clinical trial services for medical devices, specializing in market access and product registration across Asia and globally. With over 20 years of experience, they provide one-stop solutions for over 1,000 clients.
Founded in 2000, Qualtech Consulting Corporation is a leading regulatory consulting and clinical trial (CRO) company for medical devices. With over 20 years of experience and a global network, Qualtech specializes in helping medical device manufacturers gain market access, navigate product registration, and manage post-market activities. They offer comprehensive one-stop solutions, leveraging a cross-disciplinary team of professionals dedicated to integrity, diversity, and continuous learning. Qualtech has successfully assisted over 1,000 clients in achieving market access in various regions and has managed over 5,000 medical device licenses with precision. Their expertise includes Clinical Evaluation Report (CER) writing, crucial for entering markets like the EU and China. They are also adept at navigating specific regional regulations, such as updates from the Thai FDA and Malaysian MDA. With local representation in 12 markets worldwide, including China, Japan, Singapore, Malaysia, Philippines, Hong Kong, Indonesia, and Vietnam, Qualtech provides real-time services and support. They are committed to offering professional assistance without delay, assigning dedicated account managers backed by a strong tech center to ensure an efficient and enjoyable client journey. Their services encompass product registration, clinical services, and authorized representation, making them a trusted partner for medical device companies seeking to expand their business globally.
About
**Who they are**
Qualtech Consulting Corporation Pty Ltd, founded in 2000, is a regulatory consulting firm specializing in medical device services. They offer a comprehensive suite of solutions to help manufacturers navigate global market access and product registration.
**Expertise & scope**
* Regulatory consulting for medical devices
* Product registration services
* Clinical trial services (CRO)
* Local Authorized Representation
* Post-market activities
* Market access and product registration across Asia and globally
**Reputation / proof points**
* Over 20 years of experience in the medical device market.
* Assisted over 1,000 companies in entering Asian markets.
* First company to conduct and pass clinical inspection of GCP medical materials by the Taiwan Ministry of Health and Welfare.
* Passed multiple GCP inspections in China.
* Operates locally through subsidiaries in serviced countries.
* Offers one-stop solutions with dedicated account managers and a tech center.
Qualtech Consulting Corporation Pty Ltd, founded in 2000, is a regulatory consulting firm specializing in medical device services. They offer a comprehensive suite of solutions to help manufacturers navigate global market access and product registration.
**Expertise & scope**
* Regulatory consulting for medical devices
* Product registration services
* Clinical trial services (CRO)
* Local Authorized Representation
* Post-market activities
* Market access and product registration across Asia and globally
**Reputation / proof points**
* Over 20 years of experience in the medical device market.
* Assisted over 1,000 companies in entering Asian markets.
* First company to conduct and pass clinical inspection of GCP medical materials by the Taiwan Ministry of Health and Welfare.
* Passed multiple GCP inspections in China.
* Operates locally through subsidiaries in serviced countries.
* Offers one-stop solutions with dedicated account managers and a tech center.
Additional information
Qualtech emphasizes a customer-oriented approach, providing services without delay and assigning dedicated account managers backed by their tech center. Their extensive experience and international network aim to facilitate a smooth journey for clients seeking to expand their business worldwide. The company's professionals stay updated on new products and market regulations to deliver effective solutions.
Key Highlights
-
Founded in 2000, offering over 20 years of experience in medical device regulatory consulting.
Source
“Founded in 2000, Qualtech Consulting Corporation has been providing medical device manufacturers with high quality services”
-
Helped over 1,000 companies enter Asian markets.
Source
“We have over 20 years experience on medical device registration and helped more than 1,000 companies entering Asian markets.”
-
First company to pass clinical inspection of GCP medical materials by Taiwan Ministry of Health and Welfare.
Source
“We are the 1st company to carry out and pass the clinical inspection of GCP medical materials by the Taiwan Ministry of Health and Welfare.”
-
Operates locally through subsidiaries in serviced countries.
Source
“Qualtech Operates Locally through our Subsidiaries in Every Serviced Country.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers seeking market access in Asia and globally
- Companies requiring regulatory consulting and product registration support
- Businesses needing authorized representation and post-market services
How engagement typically works
- Dedicated account management
- One-stop solution provider
- Local subsidiary support
Typical deliverables
- Regulatory strategy and consulting reports
- Product registration documentation
- Clinical trial management
- Authorized representative services
- Post-market surveillance plans
Good to know
- Best when requiring specialized medical device regulatory expertise
- Best when targeting Asian markets or global expansion
HQ:
Taipei, Taiwan
Languages:
English, Korean, Japanese, Chinese
Timezones:
Australia/Sydney
Status:
listed
Services & Capabilities
AU TGA Sponsor Services
Jurisdictions:
AU
Countries:
AU
Industries:
Hospital equipment, Consumables, Medical devices
Portfolio:
26-100
Onboarding time:
3–21 days
Pricing model:
Custom pricing
Starting from:
AUD 8,000
Included services:
Annual ARTG charge reminders and continuity planning, Post-market vigilance support and incident reporting workflow, ARTG inclusion application preparation and submission, TGA device classification and grouping
Evidence Review:
Yes
Additional tga_sponsor_au Details
Supports Artg
true
