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Special Access Medical Device

 

Please be informed that our email sa.cm@mdb.gov.my will permanantely closed on 1st May 2022.

For future correspondance please submit to sa.cm@mda.gov.my .

 

Latest updates:

1. Completed applications (new/resubmit/appeal/change notification/re-evaluation) received before 15th February 2022 will be discussed in the Expert IVD Evaluation Committee Meeting which is scheduled to be held on Thursday, 3rd March 2022.

2. Latest Policy on Registration of COVID-19 Test (Professional Use Kit and Self-Test)
https://portal.mda.gov.my/documents/ukk/1908-pengumuman-pendaftaran-kit-ujian-covid-19-revised/file.html

3. Guideline For Registration of COVID-19 IVD Test Kits
https://portal.mda.gov.my/documents/guideline-documents/1910-gl-registration-covid-19-ivd-test-kits-published/file.html

 

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 April 20th, 2022

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

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