conformity assessment procedures for medical devices approved by recognized countries

Conformity Assessment Procedures for Medical Devices Approved by Recognized Countries

There is new guidance that is effective immediately from the Medical Device Authority (MDA) in Malaysia. It released Appendix 1,5th Revision of Circular Letter of the Medical Device Authority 2 Year 2014 (Appendix 1-Revision 4). This appendix describes the process for conducting conformity assessment by way of verification of the evidence for medical devices that have been approved by regulatory authorities or notified bodies recognized by the Medical Device Authority (MDA). This appendix has been revised from its 4th Revision and the changes and main topics covered in this appendix are:

  • Table 1, Recognized foreign regulatory authorities and notified bodies and the respective approval types eligible for conformity assessment by way of the verification process.
  • Annex A, Conformity Assessment Report Template: Improvement on Common Submission Dossier Template (CSDT) elaboration under 3) Conformity Assessment of Technical Documentation.

First, is a re-addition of approval type issued by European Union (EU) Notified Bodies are including the EC Certification (CE Marking) against EU Medical Device Regulations and EU IVD Regulations or medical devices which listed in European Database on Medical Devices (EUDAMED), a Databank on Medical Devices which came into force since May 2011 and was created to strengthen market surveillance and transparency with regards to medical devices placed on the European market. It explains the rules and procedures you need to follow to make sure your business meets all the requirements of the directive.

The MDA lists the annexes that are applicable for general medical devices and in-vitro diagnostic medical devices so that the applicant is clear about which Annex will be applied to the category and classification of the device included for the registration submission.

Second, improvement on Common Submission Dossier Template (CSDT) elaboration under 3) Conformity Assessment of Technical Documentation. These changes will affect all local Conformity Assessment Bodies who registered with MDA. They are required to follow the conformity assessment report as stipulated in Annex A from the 5th Revision of Circular Letter of the Medical Device Authority No. 2 Year 2014.

Click here for the IMPROVEMENT OF MEDICAL DEVICE AUTHORITY CIRCULAR NO. 2/2014 (REVISION 5):

https://portal.mda.gov.my/announcement/932-penambahbaikan-surat-pekeliling-pihak-berkuasa-peranti-perubatan-bil-2-2014-semakan-5-penilaian-pematuhan-bagi-peranti-perubatan-yang-telah-diluluskan-pihak-berkuasa-negara-lain-yang-diiktiraf.html  If you have any questions about the news published by MDA, or our services for medical device registration and representation in Malaysia, please contact us at contact@andamanmed.com

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