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 MALAYSIA: Revisions introduced to the circular letter about control of orphaned, obsolete and discontinued medical device healthcare and related facilities - February, 2020

MALAYSIA: Revisions introduced to the circular letter about control of orphaned, obsolete and discontinued medical device healthcare and related facilities - February, 2020

  • 2020-02-21 07:22:04

Earlier in January 2020, MDA had released a revised Circular Letter No. 2 Year 2018, on the control of orphaned, obsolete and discontinued medical device healthcare and related facilities. There have been some revisions introduced to the definition of types of medical devices covered in this circular letter.

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 MALAYSIA: Revisions introduced to guidance document on import and/or supply of unregistered medical devices for the purpose of demonstration for marketing or education - February, 2020

MALAYSIA: Revisions introduced to guidance document on import and/or supply of unregistered medical devices for the purpose of demonstration for marketing or education - February, 2020

  • 2020-02-21 07:21:24

MDA has introduced new revisions to the Guidance Document on Import And/or Supply of Unregistered Medical Devices for The Purpose of Demonstration for Marketing or Education. All stakeholders are advised to take of these changes while making an application for the Notification of Medical Device for Demonstration purposes, to ensure a smooth process.

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Whole new services in Malaysia!

Whole new services in Malaysia!

  • 2020-02-15 08:22:55

In order to provide customers with more complete medical device regulatory services in the Asian region, Qualtech establishs service presence in Malaysia.

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MALAYSIA: Revision introduced to the circular letter on post-market responsibilities for manufacturer and authorized representative - December, 2019

MALAYSIA: Revision introduced to the circular letter on post-market responsibilities for manufacturer and authorized representative - December, 2019

  • 2020-02-21 06:59:18

MDA has introduced a revision to the Circular Letter No 1 of Year 2019: Post-Market Responsibilities for Manufacturer and Authorized Representative. This Ciruclar Letter essentially discusses all the duties and obligations which fall upon local manufacturers and local authorized representatives, after placing devices on the market.

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