Andaman Medical Pte Ltd of Singapore at MEDICA 2021 in Düsseldorf -- MEDICA - World Forum for Medicine
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Andaman Medical Pte Ltd

Tampines Junction Business Center Level 09-02, 300 Tampines Avenue 5, 529653 Singapore
Singapore

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Hall map

MEDICA 2021 hall map (Hall 10): stand D54

Fairground map

MEDICA 2021 fairground map: Hall 10

Contact

Victoria Caldy

Marketing and Business Development Director

Shouzheng Tan

Inside Sales Specialist

Mourad Kholti

CEO

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Our range of products

Product categories

  • 07  Medical services and publications
  • 07.10  Consulting services for health organisations
  • 07  Medical services and publications
  • 07.17  Other medical services and publications

Other medical services and publications

Our products

Product category: Consulting services for health organisations

Medical Device and IVD registration

We undertake initial product registrations on your behalf whether standard, abridged, or via special access routes. We also undertake license transfers, change notifications and renewals. And provide ongoing regulatory support and regulatory intelligence to inform your business strategies.

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Product category: Consulting services for health organisations

Local Authorized Representation

We act as your Local Authorized Representative handling all questions and queries from the local regulatory competent authorities. We undertake all reporting including Post-Marketing Surveillance such as complaints, FSCAs and product recalls, and we monitor legal updates to ensure you’re informed of any changes that affect your products.

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Product category: Consulting services for health organisations

Importation and Master Distribution

In Indonesia, the Philippines, Thailand and Vietnam we also act as your legal importer. We handle all invoicing, customs clearance and ensure delivery of the product to your in-country distributor(s). We maintain all importation and distribution records as required by law and provide appropriate warehousing if required.

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Product category: Consulting services for health organisations

Quality Management - GDPMD(S)

We can assist you and your distributors to set up a Quality Management System namely the GDPMD (Good Distribution Practice for Medical Devices) which is a legal requirement in certain countries in Southeast Asia and is increasingly becoming the standard throughout the region. 

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About us

Company portrait

Andaman Medical is a regulatory affairs and market access consultancy specializing in the registration, authorized representation, importation and master distribution of medical devices and in-vitro diagnostics (IVDs) in Southeast Asia.

As the in-country representative, we prepare, submit and manage device registrations giving our clients independence and flexibility over their market access and distribution strategy. And we ensure medical devices obtain customs clearance and are distributed to the end customer.

We provide our clients with the ongoing regulatory intelligence and insight on how to navigate the complex regulatory arena particularly at this time of increased post-market surveillance (PMS) and constantly updated compliance requirements.

We also design, implement and audit Quality Management Systems for Good Distribution Practice for Medical Devices that is mandatory in some ASEAN countries.

Founded in 2013, we decided to focus exclusively on medical devices Southeast Asia and have grown over the last seven years to open seven offices in Singapore, Malaysia, Indonesia, Philippines, Vietnam, Thailand and Vietnam (Ho Chi Minh City and Hanoi offices), registering, maintaining and importing 1000+ medical devices of all classes and all therapeutic areas from ophthalmics to orthopedics, from cardiovascular to CNS, from diabetes to diagnostics and much, much more. We work with 100s of companies from startups to SMEs to Blue Chips assisting them to grow their businesses swiftly.

Company data

Sales volume 1-9 Mio US $
Number of employees 20-49
Foundation 2013
Area of business Medical services and publications