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.
 
Elsmar Forum Sponsor

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As for registered product, i have no experience but i do have the draft guidance which i downloaded previously when MDA open this for public comment, as attached.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.
 
Thread starter Similar threads Forum Replies Date
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
P Change on Medical Device Classifications - Dental Crowns Other Medical Device Regulations World-Wide 2
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
L Managing design projects: New Medical Device Project or Change Design and Development of Products and Processes 1
R How long to wait for Notified Body Response - Potentially significant change to a medical device CE Marking (Conformité Européene) / CB Scheme 6
S Medical Device - Change / Variations to a Medical Device EU Medical Device Regulations 4
R SaMD - Software as a Medical Device - Software change control form ISO 13485:2016 - Medical Device Quality Management Systems 3
T Change to Country of Origin on Medical Device Labeling Other Medical Device Regulations World-Wide 0
J South Korea, MFDS - Medical Device Change Management Other Medical Device Regulations World-Wide 5
J Class 1 Medical Device ECR (Engineering Change Request) Changes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
TheMightyWife Address Change - Medical Device Packaging Labelling Requirements EU Medical Device Regulations 7
C Vietnam - Authorized Medical Device Representative Change Other Medical Device Regulations World-Wide 10
M New Medical Device Accessory with New Function - Is this a major change? Other Medical Device Regulations World-Wide 3
H Change of a medical device sterilization dose - New 510(k) necessary? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Medical Device Website Change Control ISO 13485:2016 - Medical Device Quality Management Systems 3
MDD_QNA Medical Device PCB component change IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
JoCam Validation of a change to a CE Marked Medical Device EU Medical Device Regulations 4
S Change of Medical Device Company Registered Address - Implications Quality Manager and Management Related Issues 3
M Making a change to an approved Medical Device Other US Medical Device Regulations 9
H FDA/PMA/Medical Device/Before submission/Manufacturing facility change US Food and Drug Administration (FDA) 1
B Class II and Class III Medical Device Amendment for Change in Location? Canada Medical Device Regulations 2
T Class II Medical Device with Software - Change to Computer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
G Validity for Thailand Medical Device License and can change Distributor thereafter? Other Medical Device Regulations World-Wide 3
D Change in Medical Device Shipping Box - Transport Test Required? Other Medical Device Related Standards 1
G How do I change the Medical Device Product Code in FDA site? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
A Medical Device DHF (Design History File) - One per Design Change? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
J Class IIa Medical Device - Can I over label to change an address? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Change Medical Device Class from Class II to Class I 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
M Class I Medical Device - 1st notification and change notification EU Medical Device Regulations 4
D Regulations for Relabeling of Medical Device for Address Change ISO 13485:2016 - Medical Device Quality Management Systems 1
R EU Medical Device Change Decision Tree (when to notify the NB) EU Medical Device Regulations 4
S Medical Device Subcontractor Significant Change EU Medical Device Regulations 9
E Address change on Medical Device labeling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K Change Circuit Board to CE marked product on CE Marked Medical Device EU Medical Device Regulations 2
C When to submit a 510(k) for a change to an exisiting medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 29
M Change from Automotive to Medical Device Industry Career and Occupation Discussions 3
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
S Philippines CMDL (Certificate of Medical Device Listing) Elsmar Cove Forum ToS and Forum Policies 0
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
D Medical Device Accessories Other Medical Device Regulations World-Wide 1
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
7 Iraq Medical Device Chemical Regulations Other Medical Device Regulations World-Wide 0
J UCLA extension Medical Device Engineering Program Training - Internal, External, Online and Distance Learning 0
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 2
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5

Similar threads

Top Bottom