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 Norlela - +603 - 8230 0342
- Encik Mohd Naquib - +603 - 8230 0209
Please be informed that our email sa [DOT] cm [AT] mdb [DOT] gov [DOT] my will permanantely closed on 1st May 2022.
For future correspondance please submit to sa [DOT] cm [AT] mda [DOT] gov [DOT] my .
Latest updates:
1. Please be informed that with effect from 1st July 2022, Issuance of Special Access Notification Letter for COVID-19 Test Kits (Professional Use) that have obtained the decision of Recommended for Use (RFU) are subject to the followings:
- An applicant who wishes to apply this notification is required to provide a proof of registration application that has been submitted via MeDC@St system.
- The Special Access Letter issued is valid until 28th February 2023 and multiple shipments are allowed for the importation / supply of the COVID-19 Test Kits to the permitted healthcare facility.
Note: Subsequent application is only required for addition of a new healthcare facility.
c. The applicant is required to submit the following requirements on the 15th of every month:
- A monthly report that contains information on Notification Special Access ID, Delivery Date and Quantity Delivered.
- A copy of Delivery Order (s).
2. Latest Policy on Registration of COVID-19 Test (Professional Use Kit and Self-Test)
3. Guideline for Registration of COVID-19 IVD Test Kits:
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 June 23rd, 2022
