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Asia Reg Roundup: Vietnam Decree, Malaysia Labels And More

 
• By Ashley Yeo

Medtech companies selling into the Vietnam market need to start preparing for major regulatory changes that will be introduced in 2017 via a new decree. That is the advice of Asia Regulatory Professional Association (ARPA) secretary Jack Wong and ARQon consultant May Ng, who spoke to Medtech Insight on a range of regional Asian regulatory issues for this September update.

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[Editors' note: This is the first of what is planned to be a regularly occurring feature spotlighting important developments in Asia with the help of local regulatory experts.]

Vietnam’s Decree on Management of Medical Devices (No. 36/2016/ND-CP) is coming soon – probably sooner than expected for the unprepared. The decree, issued on May 15, 2016, took effect on...

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Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

India-UK Free Trade Agreement Sets Stage For Medtech Growth, But Industry Demands Safeguards

 
• By Shubham Singh

Announced after three years of negotiation, the FTA eliminates tariffs on 99% of Indian product types, covering nearly all trade value, and reduces tariffs on 90% of UK products. Although not yet formally signed, the deal is being positioned by the Indian government as “transformative,” with an estimated economic impact of $6.4bn for the UK alone by 2040.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

More from Geography

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

Health Literacy Issues Cost Major Economies $303B Per Year, Recent Study Shows

 
• By David Ridley

By addressing disparities in health literacy, particularly in the areas of oral care, bone health, nutrition and air pollution, the consumer health industry can “save lives and billions in healthcare costs, boosting productivity and increasing GDP,” says a new report from Haleon and Economist Impact.