Sixmurs Perdana PT

Sixmurs Perdana PT Contact information, map and directions, contact form, opening hours, services, ratings, photos, videos and announcements from Sixmurs Perdana PT, Medical and health, Cakung.

Sixmurs Group of company, aims to help clients to focus and excel in their core businesses by providing essential services such as consulting, license holding, trading, importation, logistic, manufacturing etc.

Can labeling your device as "Research-Use-Only" help you enter Indonesia faster?Many medical device brands ask this when...
21/07/2025

Can labeling your device as "Research-Use-Only" help you enter Indonesia faster?
Many medical device brands ask this when planning early market entry. But RUO is not a shortcut. It is a strategic tool, and using it the wrong way can put your brand at risk.

In this post, we explain:
✔️ What RUO really means
✔️ When it can help and when it cannot
✔️ How to stay compliant while building early presence

If you are planning to enter Indonesia in 2025 or preparing your product for licensing, this is essential reading.

👉 Learn how to navigate RUO and full licensing paths the right way.
Join our expert webinar on July 30. Event details in the last slide.

GUIDELINE FOR RE-REGISTRATION OF REGISTERED MEDICAL DEVICESeptember 2022 Second EditionTo provide information and explan...
21/10/2022

GUIDELINE FOR RE-REGISTRATION OF REGISTERED MEDICAL DEVICE
September 2022 Second Edition

To provide information and explanation to the establishment on how to submit re-registration of registered medical device application under Act 737 and MDR 2012.
These are some of the information that have been updated in the 2nd edition of Medical Device 2022 updates and there are many more, some of the updates are as below:
• Re-registration Stages of Registered Medical Device
Stage 1: Application for conformity assessment conducted by Conformity Assessment Body (CAB)
Stage 2: Application for re-registration of medical device via MeDC@St.
• Re-registration Requirement and Process Flow
• Payment Information
• Fee Information
For more information and guidance, you may approach a Regulatory Affairs Specialist at Sixmurs Malaysia to guide you accordingly. Don’t hesitate to contact us at info@sixmurs.com or www.my.sixmurs.com.

Address

Cakung

Opening Hours

Monday 08:00 - 17:00
Tuesday 08:00 - 17:00
Wednesday 08:00 - 17:00
Thursday 08:00 - 17:00
Friday 08:00 - 17:00

Telephone

+628119635222

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