Tag Archive for: License Holder

Vietnam Clearing Backlog of Medical Device Registration Applications

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Survey of the Vietnam Ministry of Health (MoH) database on May 9, 2024, showed a significant rise in Class C/D medical device processing.

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Vietnam Allows Amendments to Registration Applications Under Review

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On August 16th, 2024, Vietnam MoH introduced new guidance allowing amendments to registration applications under review, enabling document updates during the process.

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Vietnam MoH Audits License Holders for Compliance

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Asia Actual Vietnam completed an MoH audit, covering key compliance areas including licensing, documentation, and operational procedures.

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Asia Actual is the Best Medical Device Consulting Company in Asia

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Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”

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THAILAND: TIPS FOR IMPORTING MEDICAL DEVICES IN A COMPLEX MARKET

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Importing medical devices into Thailand is more difficult than in other countries in the region. It is important to work with an importer with staff experienced with medical device imports to avoid customs clearance delays and added costs.

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THAILAND ELEVATES REGULATORY STATUS OF BREAST IMPLANTS

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With Regulation B.E. 2562 (revision from regulation B.E. 2540), the Thai FDA increased the regulatory status of breast implants from Notified to Licensed (Class 4)

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HONG KONG ADVANCES TOWARDS MANDATORY MEDICAL DEVICE REGISTRATION

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Hong Kong’s Department of Health officially changed the name of the Medical Device Control Office (MDCO) to the Medical Device Division (MDD) at the end of 2019.

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INDIA OFFICIALLY REQUIRES REGISTRATION OF ALL NON-NOTIFIED DEVICES

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On February 11th, 2020 the Ministry of Health and Family Welfare published the Medical Device Rules, 2020 as an amendment to the Medical Device Rules

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4 Product Development Decisions that Impact Sales Performance in Asia

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US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.

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THAILAND NOTIFIES ALCOHOL-BASED STERILIZATION PRODUCTS

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The Thai FDA increased the regulatory status of alcohol-based sterilization devices from General to Class 2 Notified.

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