Special Access Medical Device
- Guidance Document Special Access-Requirements For Ventilator During Emergency Situation
- Guidance Document Special Access-Notification-General Requirements (Document under revision)
- Disposal Of Medical Device For Special Access
- Notification Of Unregistered Medical Devices For Special Access Route B Form
- Flowchart Of Evaluation For Special Access Application For IVD Medical Devices During COVID-19 Emergency
- Supporting Documents for COVID-19 IVD Test Kits Special Access Notification
- “No Restriction Letter” ONLY valid for 6 Months (except for COVID-19 Test Kit). If you wish to continue to import and supply of the unregistered medical device , please submit a new notification.
- Officer Incharge :
- Puan Aidahwaty - +603 - 8230 0341
- Puan Norlela - +603 - 8230 0342
- Encik Mohd Naquib - +603 - 8230 0209
Latest updates:
1. Completed applications received before 4th August 2021 will be discussed in the 10th Expert IVD Evaluation Committee Meeting which is scheduled to be held on Thursday, 9th September 2021.
2. The 11th Expert IVD Evaluation Committee Meeting is tentatively scheduled for Wednesday, 6th October 2021 (cut-off date: 30th August 2021, 5:00pm.)
3. In order to prevent email deliverability issues due to platform migration of myGovUC email to a new platform, please submit Special Access Notification to sa.cm@mdb.gov.my.
4. Please use Route B for COVID-19 Test Kits Special Access Notification.
Additional Information on COVID-19 Test Kit Special Access Notification
Instant guide to Covid-19 Test Kit Special Access Notification
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No. |
New Application |
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1. |
*Special Access Form - Route B *Remark : Information on Section B : Medical Practitioner Details is not necessary |
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2. |
List of supporting documents: i. Copy of Legal Manufacturer’s QMS ISO 13485 Certificate ii. Pre-market Approval/Registration Certificate/Emergency Use Authorization iii. Instruction for Use (IFU) iv. Full Performance Report/Clinical Study Report provide by Legal Manufacturer v. Copy of Establishment Licence of Applicant (for company) vi. Letter of Authorization (LoA) from the Legal Manufacturer vii. Information on Batch Lot Number Remark: Only completed application will be tabled at The Expert Committee Meeting |
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3. |
MDA will notify the applicant of the decision made by the MDA Expert IVD Evaluation Committee. |
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4. |
For application which has obtained the decision of “Recommended for Evaluation”, a letter for the purposes of importation and evaluation by recognised local laboratory will be issued. The applicant will liaise with the respective laboratory for sending test kit to be evaluated. |
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5. |
For application which has obtained the decision of “Recommended to be Used”, the applicant is required to submit: i. Information on Section B : Medical Practitioner Details ii. Purchase Order (as an evidence that the unregistered test kit is requested by the Healthcare Practitioner) |
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6. |
After requirements set out in paragraph 5 have been fulfilled, invoice will be issued. *Remark: The Special Access Fees is for RM300.00 per healthcare facility |
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7. |
*Payment needs to be made by the applicant before issuance of Special Access Letter. *Remark: Payment can be made via Bank Draft or Telegraphic Transfer/Direct Bank Transfer |
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Subsequent Application (Addition of Healthcare Facility/Test Kit) |
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1. |
Special Access Form - Route B *Remark : Information on Section B is necessary |
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2. |
Supporting document: Purchase Order (PO) |
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3. |
After requirements set out in paragraph 1 and 2 have been fulfilled, invoice will be issued. *Remark: The Special Access Fees is for RM300.00 per healthcare facility |
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4. |
*Payment needs to be made by the applicant before issuance of Special Access Letter. *Remark: a. Payment can be made via Bank Draft or Telegraphic Transfer/Direct Bank Transfer. b. No payment is required for an extension of supply/import of the unregistered medical device to the existing healthcare facility (that has previously obtained a Special Access Letter). |
Last updated August 20, 2021
