Debel Co. Ltd. Thailand

THAILAND'S

BOUTIQUE

INTERNATIONAL TRADE &

MEDICAL BUSINESS

CONSULTANTS

Serving Foreign Manufacturers and Companies To Ensure Successful Market Expansion of Medical Devices and Healthcare Products in Thailand

OUR

SERVICES

BUSINESS STRATEGY & MARKET RESEARCH

Our firm helps you assess the viability of your product in the Thai market.

We provide you with market research, due diligence and the most up-to-date resources to help you see the potential risks, challenges and opportunities of importing your medical devices and products to Thailand.

MARKET ENTRY SERVICES

We leverage our network of businesses and channels to help you gain market access. These services include and are no limited to:

- Distribution Strategy

- Distributors Search & Assessment

- Distribution Contract Negotiation

- Local Management of Distributors

- Liaison with hospitals, clinics and key personnel

CLINICAL

EVALUATIONS

In many occasions, the Thai FDA may request clinical data or local clinical trials for product approval. Debel will refer you to reputable partnering labs and research organizations

FDA REGISTRATION & COMPLIANCE

Thailand has a complex framework of laws and regulations for medical devices that are unlike anywhere else in the world. We prepare the necessary documentation to complete your submission and handle the entire process until your product is approved to help you save time, avoid resubmission of paperwork and fees. Our services cover the following:

- Pre-Market Approval

- Gap Assessment

- Post-Marketing Control & Vigilance

- Quality Compliance & Audits

- Main Documents for Import License

- Product Labelling Requirements

- Report Adverse Events

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LOCAL AUTHORIZED REPRESENTATION

Debel can help you set up your company's local office in Thailand. We can also serve as your local agent. We provide the following services:

- Locally represent your company

- Register your products for THai FDA approval

- Correspond with the Thai Ministry of Public Health and FDA Division on your behalf

- Keep your company updated of any new regulations or changes

- Handle import procedures with FDA inspectors and customs officers

- Handle and track complaints

- File any changes to your product, new labelling or packaging

- Report adverse events

SUPPLY CHAIN & SOURCING

Debel can match you with reputable Thai businesses and suppliers, while help to identify and manage supply chain risks. We assist our clients in sourcing quality products, from providing supplier due diligence reports to negotiating prices and finalzing purchasing agreements.

WHY CHOOSE US?

Debel offers reliable services with guaranteed results and personalized service. We work with reputable clients from around the world, working closely with each individual client to understand the nature, challenges and demands of their business. As a Thai-based firm, we leverage our knowledge of the Thai industries and regulations to ensure market penetration success and growth for our clients. We’d be pleased to apply our experiences, solutions and results on your behalf and start to gain your trust.

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