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Medical Devices Conformity Assessment

Why Need Medical Devices Conformity Assessment?

 

Section 10 of Medical Device Act ( Act 737 ) requires a medical device to undergo conformity assessment by a registered CAB prior to its registration. However, many medical devices have undergone conformity assessment and approved in countries recognized by Medical Device Authority (MDA).

 

MDA Circular Letter No 2/2014 sets the policy relating to conformity assessment for medical devices approved by countries recognized by MDA. The policy simplifies the process of conformity assessment and accelerate medical device registration under Act 737.

 

All medical devices manufactured, imported or distributed in Malaysia shall be subjected to conformity assessment as stipulated as per above requirements.

 

Medical devices which have not been obtained with any approvals by regulatory authorities or notified bodies listed in Table 1 are required to undergo full conformity assessment by any registered CAB in accordance with the requirements as stipulated in Section 7(1)(a) of Act 737.

 

The Certification Process

 

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Frequently Asked Questions

Suitable for which organization ?
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Any organization, large or small, regardless of its field of activity or products and services it provides, can get Medical Devices Conformity Assessment certified.
If my organization already being certified by others certification body , can we transfer to KIWACERT ?
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Yes of course, we can transfer & continue your certification with NO GAP in your certificate validity. Also , we won't charge you extra on the transfer registration.
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Kiwa International Certifications(M) Sdn Bhd

2A, Jalan Astana 1D, Bandar Bukit Raja, 41050 Klang, Selangor

+603-3884 7813

info@kiwacert.com

Accredited to ISO/IC 17021:2015

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ACB QMS 28

ACB OSH 17

ACB EMS 20

ACB GMP 06

ACB FSMS 13

ACB HACCP 08

ACB MDMS 05

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2022 © Kiwa International Certifications (M) Sdn Bhd. ALL Rights Reserved.

Kiwa International Certifications(M) Sdn Bhd

2A, Jalan Astana 1D, Bandar Bukit Raja, 41050 Klang, Selangor

+603-3884 7813

info@kiwacert.com

Accredited to ISO/IC 17021:2015

A Simple Image
A Simple Image

ACB QMS 28

ACB OSH 17

ACB EMS 20

ACB GMP 06

ACB FSMS 13

ACB HACCP 08

ACB MDMS 05

A Simple Image
A Simple Image
2022 © Kiwa International Certifications (M) Sdn Bhd. ALL Rights Reserved.