• Laman Utama
  • Industri
  • Pengecualian
  • Peranti Perubatan Akses Khas

Special Access Medical Device

Latest updates:

1. All application received before 10th June 2021 will be discussed in the 8th Expert IVD Evaluation Committee Meeting which is scheduled to be held on Wednesday, 7th July 2021.

2. The 9th Expert IVD Evaluation Committee Meeting is tentatively scheduled for Friday, 6th August 2021 (cut-off date: 25th June 2021, 5:00pm.)

3. The 7th Expert IVD Evaluation Committee Meeting was held on Tuesday, 15th June 2021.
(Matters arising: Antigen Rapid Test Self-Test Kits)

4. 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.

5. Please use Route B for COVID-19 Test Kits Special Access Notification.

 

Additional Information on COVID-19 Test Kit Special Access Notification

 CN

 

Instant guide to Covid-19 Test Kit Special Access Notification

No.

New Application

1.     

*Special Access Form - Route B

*Remark : Information on Section B : Medical Practitioner Details  is not necessary

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

3.     

MDA will notify the applicant of the decision made by the MDA Expert IVD Evaluation Committee.

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.

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)

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

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

 

Subsequent Application

(Addition of Healthcare Facility/Test Kit)

1.     

Special Access Form - Route B

*Remark : Information on Section B is necessary

2.     

Supporting document: Purchase Order (PO)

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

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 May 19, 2021

Cetak

  Pihak Berkuasa Peranti Perubatan Malaysia,
Kementerian Kesihatan Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

Today 7153 Yesterday 6004 Week 27473 Month 98031 Jumlah Pengunjung: 1160537

  • Kemaskini Terakhir: 23 Jun 2021.
facebooktwitterinstagramyoutube
Copyright © 2021 Medical Device Authority
Ministry of Health Malaysia
Best view with Firefox 64 and above, minimum resolution 1366x768