We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Malaysian Authorities Grant Reprieve on Device Registration

Malaysian Authorities Grant Reprieve on Device Registration

July 17, 2015

Malaysia’s Medical Device Authority has extended the application deadline for medical device manufacturers to register their products in that country.

In an announcement posted to its website, the regulator says manufacturers have until June 30, 2016, to register their devices. The original deadline, which was set by the 2012 Medical Device Act, was June 30. With this new announcement, manufacturers that submit their applications within the year timeframe may continue to import, export and market their products, pending a positive determination from the authority.

Prior to the MDA’s announcement, manufacturers that failed to take advantage of fast-track registration by June 30 would have had their products blocked from importation (IDDM, March 27). This registration option was available for devices approved for marketing in the U.S., EU, Canada, Japan or Australia. Manufacturers would then have to identify a conformity assessment body by July 1, 2018, and obtain a conformity assessment by July 1, 2020.

“Many foreign device manufacturers have not yet taken advantage of the expedited registration offered during the transition period,” explains Ames Gross, president of Pacific Bridge Medical. “Since the new regulations are still evolving, obtaining accurate information on what needs to be done has not been easy. Although the registration process itself is not overly daunting, the numerous regulatory adjustments announced in the past year and the lack of clarification on some of the guidelines might have made it difficult for device companies to follow through with their application.”

Gross adds that international companies may not have felt the need to exhaust their resources to conduct a last-minute registration for Malaysia. Regulatory affairs professionals must register their products in multiple regions, and Malaysia is a smaller market. “When Singapore offered a similar expedited registration process during their transition to mandatory registration requirements for medical devices a few years ago, many companies failed to take advantage of the opportunity then as well,” he says.

To see the MDA announcement, visit www.fdanews.com/072015-malaysian-registration-extension.pdf. —Elizabeth Hollis

Regulatory Affairs

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • AstraZeneca

    AstraZeneca Withdraws Imfinzi’s Bladder Cancer Indication

  • CE mark

    Cue Health’s COVID-19 Test Receives CE Mark

  • Sanofi-Regeneron_Logos.png

    Sanofi’s and Regeneron’s Libtayo Wins FDA Approval for NSCLC

  • PerkinElmer logo

    PerkinElmer’s Rapid Point-of-Care COVID-19 Test Cleared in Europe

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing