Malaysia’s Medical Device Authority (MDA) has released draft guidance on medical device grouping classification rules. The draft guidelines are open for comment by stakeholders until 28 February 2022. The purpose of the document is to provide guidance on determining the appropriate grouping for medical devices during the medical device registration application.
This draft guidance applies to all products that fall within the definition of medical device that has been specified in the “Guidance Document: Definition of Medical Device” (MDA/GD/0006). The groupings are categorized as:
- SINGLE
- FAMILY
- SYSTEM
- SET.
The first edition of this guidance document, MDA/GD/0005 October 2013, included In-Vitro Diagnostics, however, this second edition excludes In-vitro Diagnostics as these are now covered in separate specific guidance (MDA/GD/0054) on the grouping of IVDs. See here for our article on In-Vitro Diagnostic Medical Device Product Grouping.
This draft second edition introduces three additional Special Groupings as follows:
- In-Vitro Fertilisation Medical Devices
- Hearing Aids
- Dental Medical Devices.
Special Grouping for In-vitro Fertilisation (IVF)
IVF media products may be grouped into one of four IVF media grouping categories and therefore submitted in one application for registration if they satisfy the criteria below:
- a) from the same product owner
- b) compatible when used together and intended to be used for an IVF procedure
For more information see Table 1 in the draft guidance for IVF Media Grouping Categories.
Specific Grouping for Hearing Aids
This grouping applies to hearing aids from the same manufacturer that have a Class B risk-based classification. The medical devices must have the same design, sound amplification and communication technologies. The grouping does not include implantable hearing aid devices.
Specific Grouping for Dental Medical Devices
A grouping of “dental medical devices” is possible when each individual device in the grouping:
- is from the same manufacturer
- is of the same risk classification and
- the intended purpose is the same.
For more information see Table 2 in the draft guidance on Medical Device Guidance Documents for information related to Dental Medical Device Grouping.
Other minor changes introduced in this draft second edition of the guidance include the definition and decision flow chart for grouping “Single, Set, Family, System”. In particular, the List of Permissable Variants for grouping as a “Family’ has been changed and updated.
How to submit comments
Comments can be submitted to the MDA through the BK_BDKS_054 Feedback Form Comments on Medical Device Grouping which is to be sent to anissuhaila@mda.gov.my. The deadline for comments is 28 February 2022.
For more information
Click here for the draft guidance on Medical Device Product Grouping
If you have any queries regarding medical device grouping, please contact your Regulatory Affairs Specialist at Andaman Medical or click the button below.
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