Newsletter

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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INDONESIA: Registration of prospective providers in Electronic Catalog (E-Cat) for medical device and household-health product through the negotiation method – December, 2019

INDONESIA: Registration of prospective providers in Electronic Catalog (E-Cat) for medical device and household-health product through the negotiation method – December, 2019

  • 2020-02-21 06:56:04

In Indonesia, E-Katalog become the most popular platform for the public hospital or government related institution to find required medical device equipment. In October, Government invite Medical Device Company to submit an offering of Medical Devices and Household Health Supplies products to be included in E-Katalog.

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INDONESIA: Medical device amendment criteria in Indonesia - December, 2019

INDONESIA: Medical device amendment criteria in Indonesia - December, 2019

  • 2020-02-21 06:54:34

Changing some information after device approved can be done through amendment which has shorter timeline for approval. However, not all of the changes in the device can apply for amendment. Indonesia Ministry of Health elaborate specific criteria for the type of changes that can be reported as amendment to MoH.

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