Medical Device Change Requirements - Malaysia Registered Products

M

medi12

#1
Hi all,

Does somebody know how device changes (minor and major) to registered medical devices must be handled in Malaysia? Is a new registration/approval necessary? Maybe there exists a similar guidances as the "Deciding when to submit a 510k for a change to an existing device" guidance of the FDA but I was not able to find it.

Best Regards.
 
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Murni Ahmad

Involved In Discussions
#2
Hi all,

Does somebody know how device changes (minor and major) to registered medical devices must be handled in Malaysia? Is a new registration/approval necessary? Maybe there exists a similar guidances as the "Deciding when to submit a 510k for a change to an existing device" guidance of the FDA but I was not able to find it.

Best Regards.
Hi there,

To my knowledge the "Change notification" guidance is yet to be published officially and still in draft. I was advised that any changes should be absorbed in during the submission in [email protected] if your product is still under evaluation.

As for registered product, i have no experience but i do have the draft guidance which i downloaded previously when MDA open this for public comment, as attached.

Regards,
Murni
 

Attachments

Mallappa

Involved In Discussions
#3
Hi Murni Ahmed,

Do the domestic manufacturers need CFS for the registration of medical devices with MDA in Malaysia?

As per my knowledge, Export permit or Certificate of Free Sale (CFS) is the certificate required by the importing country to certify that the products are already sold in the country of origin or eligible for export.

  • CFS is not required for domestic manufacturers for the registration of medical devices manufactured in Malaysia.
  • In case of OBL, CFS from exporting country may be required for the registration of medical devices which are manufactured outside Malaysia.

Regards,
Mallappa
 

Jen

Starting to get Involved
#4
Hi Murni Ahmed,

Do the domestic manufacturers need CFS for the registration of medical devices with MDA in Malaysia?

As per my knowledge, Export permit or Certificate of Free Sale (CFS) is the certificate required by the importing country to certify that the products are already sold in the country of origin or eligible for export.

  • CFS is not required for domestic manufacturers for the registration of medical devices manufactured in Malaysia.
  • In case of OBL, CFS from exporting country may be required for the registration of medical devices which are manufactured outside Malaysia.

Regards,
Mallappa
I don't think MDA requires any CFS for medical device registration.
 

Murni Ahmad

Involved In Discussions
#5
Hi Murni Ahmed,

Do the domestic manufacturers need CFS for the registration of medical devices with MDA in Malaysia?

As per my knowledge, Export permit or Certificate of Free Sale (CFS) is the certificate required by the importing country to certify that the products are already sold in the country of origin or eligible for export.

  • CFS is not required for domestic manufacturers for the registration of medical devices manufactured in Malaysia.
  • In case of OBL, CFS from exporting country may be required for the registration of medical devices which are manufactured outside Malaysia.

Regards,
Mallappa
Hi There,

Sorry for this late reply.
No, CFS is not a mandatory requirement for registration of medical device in Malaysia,
that being said, for imported devices.
CFS needed for export (out of Malaysia) - if required by the importing country - which usually in the case of the local manufacturer exporting out.

CFS however, usually asked by CAB or MDA officer, for the marketing history - a part of CSDT. But in very rare case.
At all time the approval from GHTF country are mandatory - for verification rout = simpler
Without GHTF country approval - need to do full evaluation route = longer
 
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