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Expert Medical Device Consulting and Market Access Solutions

Headquartered in Austin, Texas, Asia Actual has offices staffed by experienced, bilingual regulatory and commercial professionals in the major capital cities of Asia.

We distinguish ourselves with (1) outstanding personnel; (2) clear communication; and  (3) transparent operations.

Please contact us today for a free consultation to learn more about your market access options in Asia.

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US

HEADQUARTERS

515 Congress Avenue, Suite 2100
Austin, TX 78701

+1 512 898-9222

inquiry@asiaactual.com

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SOUTHEAST ASIA

HEADQUARTERS

116 Changi Road, #04-05
Singapore 419718

+65 8800-3197

Latest News.

CDSCO Issues Updates to IVD Classification List in India

The Central Drugs Standard Control Organisation (CDSCO) of India issued a notice (PDF) on October 25, 2023 classifying in-vitro diagnostic (IVD) medical devices under medical device rules. The updates to IVD classification in India include intended use, associated risk, and other parameters.
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Embracing Innovation and Collaboration: Highlights from the 15th CII Global MedTech Summit

On October 6, 2023, a team of enthusiastic members from the AAI (Artificial Intelligence and Innovation) group, including Ashoniya Puri, Sanjay Singh, and Rajat Budhori, had the honor of attending the prestigious 15th CII Global MedTech Summit. Hosted by the Confederation of Indian Industry (CII), one of India's largest industry bodies, this event brought together key players in the MedTech sector, both from India and abroad. The summit revolved around the central theme, "Paving the way for a USD 50 billion MedTech Industry by 2030," signifying a collective vision for the industry's future growth.
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Bangladesh LAUNCHES NEW MEDICAL DEVICE REGULATIONS

On September 18, 2023, The Directorate General of Drug Administration (DGDA) published the Drug and Cosmetics Act 2023 formalizing the regulatory requirements of medical and diagnostic devices in Bangladesh with immediate effect.  A translated version of the document is available on Asia Actual’s website here.  All medical devices now require a Marketing Authorization Certificate to clear Customs and be sold on the market in Bangladesh.
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