GUIDELINE FOR REGISTRATION OF DRUG-MEDICAL DEVICE AND MEDICAL DEVICE-DRUG COMBINATION PRODUCTS

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1.1. Product Classification

Before submission of application for a product registration, applicants may submit for product classification if unsure of the product category.

i. Product Classification Guideline

ii. Product Classification Form  : Ms Word  |  PDF 

 

1.2. Payment Mode

Online payment option available for applicants:

i. Payment Using Personal/Current Account - B2C

ii. Payment Using Corporate Account - B2B

ii. Payment Using Credit Card

 

1.3. Product Category: 

1.3.1 DRUG-MEDICAL DEVICE COMBINATION (NPRA AS PRIMARY AGENCY)

The registration process of Drug-Medical Device combination product shall undergo the following 3 stages:

i. Stage 1 – Obtaining Certification from CAB

The ancillary dossier in which the ancillary medical device component falls under Class B, C and D against the Classification of Medical Device found in First Schedule Medical Device Regulation 2012 shall be prepared in the format as specified in Appendix 2 and shall be submitted to CAB. Ancillary component that falls under Class A is exempted from this preliminary Stage 1 process. Evaluation on ancillary component shall be done by CAB. Ancillary component that falls under Class A is exempted from this preliminary Stage 1 process. Evaluation on ancillary component shall be done by CAB. CAB shall issue a certificate and report upon satisfactory review of ancillary component.

ii. Stage 2 – Obtaining Endorsement from MDA

Applicant shall submit the following documents to MDA manually:

i. Application form for Endorsement Letter of Ancillary Component for Registration of Combination Products (Appendix 4: Form for Endorsement Letter of Ancillary Component for Registration of Combination Products)

ii. Ancillary Dossier (Appendix 2: Ancillary Medical Device Dossier Requirement for Drug- Medical Device Combination Product)

iii. Certificate and report issued by CAB Ancillary medical device component that falls under Class A medical device is not required to submit document as specified in (ii) and (iii) above.

MDA shall issue an endorsement letter upon satisfactory review. 

iii. Stage 3 – Application For Registration to NPRA

For the purpose of registration of Drug-Medical Device combination products, applicant shall submit an application for registration with the following documents to NPRA via the online QUEST system at http://npra.gov.my:

i. Certificate and report issued by CAB (not applicable for Class A medical device)

ii. Endorsement letter issued by MDA

iii. Data on drug in accordance to DRGD Section B: Product Registration Process

Recommendations from the evaluation on Drug-Medical Device combination product shall be presented to the Drug Evaluation Committee followed by the meeting of DCA for approval/rejection.

The Drug-Medical Device combination product shall be registered after the approval by the DCA.

Applicant shall refer to the product registration approval notification sent by the Authority or the Approved Product Registration List in NPRA website. 

All the stages shall be completed, with the exception of Class A medical device (refer MDA GD-04: The rules of classification for general medical devices); in which it is exempted from Stage 1.

 

1.3.2 MEDICAL DEVICE-DRUG COMBINATION PRODUCT REGISTRATION PROCESS (MDA AS PRIMARY 

         AGENCY)

The registration process of Medical Device-Drug combination product shall undergo the following 3 stages:

i. Stage 1 - Obtaining Endorsement from NPRA

Applicant shall submit the following documents to NPRA manually:

i. Application Form for Endorsement Letter of Ancillary Component for Registration of Combination Products (Appendix 4: Form for Endorsement Letter of Ancillary Component for Registration of Combination Products)

ii. Ancillary Dossier (Appendix 3: Ancillary Drug Dossier Requirement for Medical Device-Drug Combination Product) NPRA shall issue an endorsement letter upon satisfactory evaluation.

ii. Stage 2 - Obtaining Certification from CAB

Applicant shall submit the primary dossier to CAB to undergo conformity assessment. CAB shall issue certificate and report upon satisfactory conformity assessment. Class A medical device is exempted from Stage 2.

iii. Stage 3 - Application for Registration to MDA

For the purpose of registering a medical device-drug combination, applicant shall submit an application to MDA via the MeDC@St system in accordance with the guideline MDA/GL/MD01 on How to Apply for Medical Device Registration under Medical Device Act 2012 (Act 737) with the following documents:

i. Endorsement letter issued by NPRA

ii. Certificate and report issued by CAB

Medical Device Authority shall register the Medical Device-Drug combination product and issue a medical device registration certificate upon approval.

 

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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