Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Asia Reg Roundup: Vietnam's Medtech Filers Under More Deadline Pressures

Executive Summary

Stakeholders aired concern in Vietnam this summer about the amount of time available for companies to meet the new national device regulatory system's July 1 deadline for class A, lowest-risk, medical device applications. There are now worries over whether the next deadline, December 31, will be met for the higher-risk category devices, according to local experts Jack Wong and May Ng in this regional update that also includes updates from Malaysia, Bangladesh and Hong Kong.

You may also be interested in...



Singapore’s Priority-Review Scheme Goes Live

Only marketing applications submitted on or after Aug. 22 will be considered for Singapore’s new priority-review scheme for medical devices.

Asia Reg Roundup: Vietnam On Track Launching New System, Plus Updates From Bangladesh, Hong Kong

All eyes are on Vietnam, which is on the threshold of a new regulatory system for medical devices. But the smaller regional markets like Bangladesh and Hong Kong are giving medtechs much to think about too, as Asia Regulatory Professional Association (ARPA) secretary Jack Wong and ARQon consultant May Ng observe in this latest Asian regulatory roundup.

Malaysia's New Medtech Regulatory System Imminent - And No More Extension This Time

Malaysia's conformity assessment-based system for medical devices will finally come into effect at midnight on June 30 2016. That is less than two weeks away, and 'there will be no extension,' says Sasikala Devi Thangavelu, director of the policy, code and standard division of the Malaysian Medical Device Authority1.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT121683

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel