Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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MINISTRY OF HEALTH MALAYSIA  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
First Edition – 15th March  2017  
Portal: www.moh.gov.my  
Email: kkm@moh.gov.my  
 
 
 
 
  
 
Medical Device Authority  
Ministry of Health Malaysia   
GUIDELINE FOR REGISTRATION OF  
DRUG -MEDICAL DEVICE AND  
MEDICAL DEVICE -DRUG  
COMBINATION PRODUCTS  Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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 PREAMBLE  
 
 This present guideline serve s as a guidance for the submi ssion of registration 
application of drug -medical device/ medical device -drug combination products.  
 
 Drug -medical device/ medical device -drug combination products are regulated 
according to the classification whether as drug or medical device.  
 
 Combinatio n products regulated as drug by Drug Control Authority is in accordance 
with the requirements set forth in the Control of Drugs and Cosmetics Regulations 
1984 which is promulgated under Sale of Drug Act 1952  and any other relevant 
documents published by NP RA. 
 
 Combination products regulated as medical device by Medical Device Authority is in 
accordance with the requirements set forth in the Medical Device Act 2012 (Act 737) 
and its subsidiary legislations , and any other relevant documents published by MDA.  
 
 Any drug substances used as ancillary to medical device which is listed as a 
scheduled poison sha ll be regulated in accordance with  the Poison Act 1952 . 
 
 The written laws shall take precedence over this guidance document in any event of 
discrepancy.  
 
 The scope of this guideline includes information relating to dossier requirements and 
procedures for submission of combination products registration application.  
 
 Applicants shall familiarize with the contents of this guidance document and the 
governing legisl ations before they s ubmit registration applications.  
 
 The Authority  may request for information or specify conditions not described in this 
document that is deemed necessary to ensure the safety, quality, efficacy and 
performance of the combination product .  
 
 The Authority  reserves the right to amend any part of this guideline whenever it 
deems fit.  
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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  This guidance shall be fully enforced  on 1st July 2018  
 
 Any enquiry on registration of combination products may refer to the relevant agency:  
 
1. Secretary,  
Drug Control Authority,  
National Pharmaceutical Regulatory Agency , 
Ministry of Health Malaysia,  
Lot 36, Jalan  Universiti,  
46200  Petaling Jaya, Selangor.  
Tel : +603 -78835400     Fax : 03-7956 2924  
E-mail : helpdesk@npra. gov.my  
Portal :  http://npra.moh.gov.my/  
 
2. Chief Executive  
Medical Device Authority (MDA),  
Ministry of Health Malaysia,  
Level 5, Menara  Prisma,   
No. 26, Jalan  Persiaran  Perdana , 
Precint 3, 62675 Putrajaya.  
Tel : +603 -8892 2400    Fax : +603 -8892 2500  
E-mail : mdb@mdb.gov.my  
Portal :  http://www.mdb.gov.my  
 
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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 GLOSSARY  
Agency:  
Refers to National Pharmaceutical Regulatory Agency  (NPRA ) or Medical Device Authority 
(MDA)  
 
Ancillary Dossier:  
Dossier required by the secondary agency  
 
Drug -Medical D evice Combination Product (DMDCP):  
Primary mode of action is  based on pharmacological, immunological or metabolic action 
in/on the body where NPRA  is the primary ag ency of the combination product  
 
Medical D evice -Drug Combination Product  (MDDCP):  
Primary mode of action in or on  the human body is not based on pharmac ological, 
immunological or metabolic means, but that may be assisted in its intended function by such 
means  where  MDA  is the primary ag ency of the combination product  
 
Primary Agency:  
Agency with primary regulatory responsibility for a combination product which is determined 
by the primary mode of action of the product  
 
Primary Dossier:  
Dossier required by the primary agency  
 
Primary Mode of Action:  
Mode of action that provides the greatest contribution to the overall therapeutic effects of the 
combination  product  
 
Secondary Agency:  
Agency that regulate the other part(s) included in the combination product  
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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 ABBREVIATIONS AND ACRONYMS  
 
CAB  Conformity Assessment Body  
CDCR   Control of Drugs & Cosmetics Regulations 1984  
COA   Certificate of Analysis  
CSDT   Comm on Submission Dossier Template  
DCA   Drug Control Authority  
DRGD   Drug Registration Guidance Document  
GMP   Good Manufacturing Practice  
MDA   Medical Device Authority  
NPRA   National Pharmaceutical Regulatory Agency  
PSUR   Periodic Safety  Update  Report  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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 CONTENTS  
1.0 INTRODUCTION  
1.1  DEFINITION OF MEDICAL DEVICE  
1.2  DEFINITION OF DRUG  
1.3  DEFINITION OF COMBINATION PRODUCTS  
  
2.0 REGISTRATION PROCESS  
2.1 DRUG -MEDICAL DEVICE COMBINATION PRODUCT REGISTRATION  
  PROCESS (NPRA  AS PRIMARY AGENCY)  
2.2  MEDICAL DEVICE -DRUG COMBINATION PRODUCT REGISTRATION  
PROCESS (MDA AS PRIMARY AGENCY)  
 
3.0 DOSSIER REQUIREMENT  
3.1 DOSSIER REQUIREMENT FOR DRUG -MEDICAL DEVICE COMBINATION  
  PRODUCT  
3.2      DOSSIER REQUIREMENT FOR MEDICAL DEVICE -DRUG COMBINATION    
           PRODUCT  
 
4.0 TIMEL INE F OR REGISTRATION OF COMBINATION PRODUCTS  
 
5.0 FEES FOR REGISTRATION OF COMBINATION PRODUCTS  
5.1 FEES IMPOSED BY NPRA  
5.2 FEES IMPOSED BY MDA  
5.3 FEES IMPOSED BY CAB  
 
6.0 CHANGES /VARIATION  TO PARTICULARS OF A REGISTERED COMBINATION  
       PRODUCT   
6.1  CHANGES/VARIATION TO PARTICULARS OF A REGISTERED  
  DRUG -MEDICAL DEVICE CO MBINATION PRODUCT  
6.2  CHANGES/VARIATION TO PARTICULARS OF A REGISTERED  
  MEDICAL DEVICE -DRUG COMBINATION PRODUCT  
 
 
 
 
 
 
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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 APPENDIX 1:  THE ILLUSTRATIVE TABLE OF DRUG -MEDICAL DEVICE/  
   MEDICAL DEVICE -DRUG COMBINATION PRODUCT  
APPENDIX 2:  ANCILLARY MEDICAL DEVICE DOSSIER REQUIREMENT FOR  
   DRUG -MEDICAL DEVICE COMBINATION PRODUCT  
APPENDIX 3:  ANCILLARY DRUG DOSSIER REQUIREMENT FOR MEDICAL  
   DEVICE -DRUG COMBINATION PRODUCT  
APPENDIX 4:  FORM FOR ENDORSEMENT LETTER OF ANCILLARY  
                                   COMPONENT FOR REGISTRATION OF COMBINATION  
                                   PRODUCTS  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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 1.0 INTRODUCTION  
 
1.1  DEFINITION OF MEDICAL DEVICE  
The term medical device includes:  
a. any instrument, apparatus, implement, machine, appliance, implant, in -vitro reagent 
or calibrator, software, material or other similar or related article intended by the  
manufacturer to be   used,  alone  or  in  combination,  for human  be ings  for  the  
purpose  of — 
i.   diagnosis, prevention, monitoring, treatment or  alleviation of disease;  
ii.   diagnosis, monitoring, treatment, alleviation of or c ompensation for  
an injury ; 
iii.   investigation, replacement or m odification, or support of the anatomy  
or of a physiological process ; 
iv. support or sustaining life; 
v.   control of conception;  
vi. disinfection of  medical device; or  
vii. providing information for medical or diagnostic purpose by means of 
in-vitro examination  of speci mens derived from the human  body,  
which  does not achieve its primary intended action in or on  the 
human body by pha rmacological, immunological or metabolic means, 
but that may be assisted  in its intended function by such means;  and 
b. any instrument, apparatus,  implement, machine, appliance, impla nt, in -vitro reagent 
or calibrato r, software, material or other similar or related article, to be used on the 
human body , which the Minister may, after taking  into co nsideration issues of public  
safety, public health or public risk, declare to be a medical  device by  order published 
in the Gazette  
 
1.2  DEFINITION OF DRUG  
Under the CDCR 1984, Regulation 2: “Product ” means:  
a. a drug1 in a dosage unit or otherwise, for use wholly or mainly by being administered 
to one or more human beings or animals for a medic inal purpose2; or  
b. a drug1 to be used as an ingredient of a preparation for a medicinal purpose2.  
 
Under Sales of Drug Act 1952, Section 2:  Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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 1. “drug ” includes any substance, product or article intended to be used or capable, or 
purported or claimed to be ca pable, of being used on humans or any animal, whether 
internally or externally, for a medicinal purpose.  
2. “medicinal purpose ” means any of the following purposes:  
a. alleviating, treating , curing or preventing a disease or a pathological condition 
or symptom s of a disease;  
b. diagnosing a disease or ascertaining the existence, degree or extent of a 
physiological or pathological condition;  
c. contraception;  
d. inducing anaesthesia;  
e. maintaining, modifying, preventing, restoring, or interfering with, the normal 
opera tion of a physiological function;  
f. controlling body weight;  
g. general maintenance or promotion of health or well  being  
 
1.3  DEFINITION OF COMBINATION PRODUCT  
The ter m combination product includes:  
i. A product comprised of two or more regulated components, i. e., drug/device, 
biological/device, or drug/device/biological, that are physically, chemically, or 
otherwise combined or mixed and produced as a single entity;  
ii. Two or more separate products packaged together in a single package or as a unit 
and comprised o f drug and device products, device and biological products.   
 
Products that are excluded from the term combination products an d will be regulated 
separately:  
i. A drug, device, or biological product packaged separately that according to its 
investigational pl an or proposed labelling is intended for use only with an approved 
individually specified drug, device, or biological product where both are required to 
achieve the intended use, indication, or effect and where upon approval of the 
proposed product labelli ng of the approved product would need to be changed, e.g., 
to reflect a change in intended use, dosage form, strength, route of administration, or 
significant change in dose; or  
ii. Any investigational drug or device packaged separately that according to its 
proposed labelling is use only with another individually specified investigational drug, 
device, or cosmetic product where both are required to achie ve the intended use, 
indication  or effe ct. Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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 iii. Convenience pack products (example: first aid kit consist of medi cal device and non -
scheduled poison products)  
 
Appendix 1  shows an illustrative table of the example of Drug -Medical Device/Medical 
Device -Drug Combination Product classification  
Prior to registration, an applicant may apply classification application to  NPRA through 
product classification form (BPFK 300 -1) which is available at http://npra.moh.gov.my  
 
2.0  REGISTRATION PROCESS OF COMBINATION PRODUCTS  
The primary agency for registration of combination product is based on the primary mode of 
action/the pri ncipal mechanism of action by which the claimed effect or purpose of the 
product is achieved:  
i. Drug is based on pharmacological, immunological or metabolic action in/on 
the body;  shall be regulated by NPRA ; 
ii. Medical devices does not achieve its primary  mode  of action in or  on the 
human body by pharmacological, immunological or metabolic means, but that 
may be assisted in its intended function by such means;  shall be  regulated by 
MDA.  
 
Flow of registration process of combination products i s illustrated in Figure 2 . 
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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*Note : Applicant may submit application for endorsement letter and registration of combination product  concurrently to both 
secondary and primary agency. However, the approval of  combination product registration is subject to primary agency bas ed 
on the fulfilment of registration requirements, as well as the receipt of endorsement letter  from secondary agency.  
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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 2.1 DRUG -MEDICAL DEVICE COMBINATION  PRODUCT REGISTRATION  
 PROCESS  (NPRA  AS PRIMARY AGENCY)  
The registration process of Drug -Medical D evice combination product shall undergo  the 
following 3 stages : 
i. Stage 1 – Obtaining Certification from CAB  
ii. Stage 2 – Obtaining Endorsement from MDA  
iii. Stage 3 – Application For Registration to NPRA  
 
All the stages shall be  complete d, 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 . 
 
Stage 1: Obtaining Certification From CAB  
 
The ancillary dossier in which the ancillary medical device component falls unde r 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. CAB shall issue a  certificate and 
report  upon satisfactory review of ancil lary component  
 
Stage 2: Obtaining Endorsement from MDA  
 
Applicant shall sub mit the following documents to MDA  manually : 
i. Application form f or 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 fall s under Class A medical device is  not required 
to su bmit document as specified in (ii) and (iii) above . 
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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 MDA shall issue  an endorsement letter upon satisfactory review . 
 
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.moh.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 D evice 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 P roduct Registration List in NPRA  website.  
 
2.2  MEDICAL DEVICE -DRUG COMBINATION PRODUCT REGISTRATION  
PROCESS (MDA AS PRIMARY AGENCY)  
The registration process of Medical D evice-Drug combination product shall undergo the 
following 3 stages:  
i. Stage 1 - Obtaining Endorsement from NPRA  
ii. Stage 2 - Obtaining Cer tification from CAB  
iii. Stage 3 - Application for Registration to MDA  
 
 
 
 
 
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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Stage 1: Obtaining Endorsement from NPRA  
 
Applicant shall submit  the following documents to NPRA  manually : 
 
i. Application Form f or Endorsement Letter of Ancillary Component for Registra tion 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 . 
 
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 a ssessment.  
Class A medical device is exempted from Stage 2.  
 
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 w ith the guideline MDA/GL/MD -
01 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 reg ister the Medical Device -Drug c ombination product and 
issue a medical device r egistration certificate upon approva l. 
 
 
 
 
 
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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3.0  DOSSIER REQUIREMENT FOR COMBINATION PRODUCT  
The following dossier shall be submitted by the applicant for the purpose of regist ering 
combination product:  
 
Table 1: Dossier Requi rement for Combination Product  
 Dossier Requirement for 
Drug Component  Dossier Requirement for 
Medical Device Component  
Drug -Medical Device 
Combination Product  Refer to DRGD,  Appendix 2:  
Requirements for Product 
Registration  Refer to Appendix 2 :  
Ancillary Medical Devic e 
Dossier Requirement for 
Drug -Medical Device 
Combination Product  
Medical Device -Drug 
Combination Product  Refer to Appendix 3:   
Ancillary Drug Dossier 
Requirement for Medical 
Device -Drug Com bination 
Product  
 Refer to MDA/GD -04: 
Common Submission 
Dossier Template First 
Edition March 2014  
 
 
 
 
 
 
 
 
 
 
 
 
 
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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 4.0 TIMELINE FOR REGISTRATION OF COMBINATION   
         PRODUCTS  
The following table  specifies  the duration (counted in working days  upon recei pt of complete 
application ) that a re required to perform product/ ancillary dossier evaluation by each 
respective agency. Due to the nature of combination product which requires evaluation effort 
from both the Primary Agency and Secondary Agency, applicants  are kindly advised to be 
vigilant on the overall timeframe required for combination product registration.  
 
Stage  Drug -Medical Device 
Combination Product  Medical Device -Drug Combination 
Product  
Stage 1   
 
Refer to CAB Evaluation Timeline  Evaluation timelin e by NPRA : 
Category  Duration  
New Chemical 
Entity  245 
Biologic 
Component  245 
Generics 
(Scheduled Poison)  90 
Generics  (Non -
Scheduled Poison)  90 
 
Stage 2  Evaluation timeline by MDA:  
Class  of 
Medical 
Device  Duration  
A 15 
B 30 
C 90 
D 110 
 Refer to CA B Evaluation Timeline  
Stage 3   
Evaluation timeline by NPRA : 
Category  Duration  
New Drug Products  245 
Biologics  245 
Generics (Scheduled 
Poison)  210 
Generics (Non -
Scheduled Poison)  210 
 Evaluation timeline by MDA:  
Class  of 
Medical 
Device  Duration  
A 30 
B 60 
C 180 
D 220 
 
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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 5.0 FEES FOR REGISTRATION OF COMBINATION PRODUCTS  
Every application for registration shall be accompanied with a fee imposed by the respective 
agencies as spe cified in the table in Section 5.1 and 5 .2.  
 
Any payment made shall NOT  be REFUNDABLE  once the application has been submitted 
and payment confirmed.  
 
Applications without the correct fees will not be processed.  
 
5.1 FEES IMPOSED BY NPRA  
Under the CDCR 1984, Regulation 8(3): The Authority may charge any applicant such costs 
as it may incur for the purpose of carrying out any evaluation or investigation prior to the 
registration of any product.  
 
No. Category of 
Product  * Processing 
Fees  Analysis Fees  Total Fees  
Drug -Medical Device Combination Product  
1. Pharmaceutical  
a. New Drug  
Products  
b. Biologics  RM 1,000.00  Single active ingredient :  
RM 3,000.00  RM 4,000.00  
Two or more active ingredients :  
RM 4,000.00    RM 5,000.00  
2. Pharmaceutical  
a. Generic 
(Scheduled 
Poison)  
b. Generic (Non -
Scheduled 
Poison)  
 RM 1,000.00  Single active ingre dient :  
RM 1,200.00  RM 2,200.00  
Two or more active ingredients:  
RM 2,000.00    RM 3,000.00  
* As stipulated in the CDCR 1984, Regulation 8.  
 
 
 
 
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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 Fees imposed for medical device -drug combination product:  
Category of ancillary drug component  Processing F ees 
1. New Chemica l Entity  
2. Biologic Component  
3. Generics (Scheduled Poison)  
4. Generics(Non -Scheduled Poison)   
 
RM 1,000.00  
 
 
5.2 FEES IMPOSED BY MDA  
Application shall be accompanied with fees as specified to Fifth Schedule of M edical Device 
Regulation 2012.  
Medical Device -Drug  
Combination Product  
(RM) Drug -Medical Device  
Combination Product  
(RM) 
Application Fee  Registration Fee  Administration  Fee 
750 5000 100 
 
 
5.3 FEES IMPOSED BY CAB  
Refer Circular Letter of Medical Device Authority No.2 Year 2014 . 
 
 
 
 
 
 
 
 
 
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 6.0 CHANGES/VARIATION TO PARTICULARS OF A REGISTERED   
        COMBINATION PRODUCT  
 
6.1 CHANGES/VARIATION TO PARTICULARS OF A REGISTERED DRUG - 
MEDICAL DEVICE COMBINATION PRODUCT  
Application for changes to particular s of drug component for a registere d Drug-Medical 
Device  combination product  shall be required  to comply to Section 5.2 : Amendments To 
Particulars Of A Registered Product of DRGD . 
 
Application for changes to particular s of ancillary medical device component for a registered 
drug-medical de vice combination product shall be submitted to MDA for endorsement letter.  
The endorsement letter shall then be req uired to be sent to NPRA  for notification.  
 
6.2 CHANGES/VARIATION TO PARTICULARS OF A REGISTERED MEDICAL   
         DEVICE -DRUG COMBINATION P RODUCT  
Application for changes to particular s of medical device component for a registered medical 
device -drug combination product  shall be required  to comply to the Guidance Document of 
Change Notification to Registered Medical Device . 
 
Application for ch anges to particular s of ancillary drug component for a registered medical 
device -drug combination product shall be  submitted to NPRA  for endorsement letter. The  
endorsement letter shall then be required to be sent to MDA for notification.  
 
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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 APPENDIX 1:  THE ILLUSTRATIV E TABLE OF DRUG -MEDICAL  
    DEVICE/ MEDICAL DEVICE -DRUG COMBINATION   
    PRODUCT  
 
Table 1      : Example of Drug -Medical Device Combination Product  
    Classification  
 
NO PRODUCT  INTENDED PURPOSE/ 
INDICATION AND MODE OF 
ACTION (MOA)  CATEG ORY CUSTODIAN 
AGENCY  
1. Drug -Eluting Beads  
(Produced from 
biocompatible polyvinyl 
alcohol hydrogel  
modified with 
sulphonate groups  in 
phosphate buffered 
saline.)  
 It is an embolic agent which is 
intended to be loaded with a 
chemotherapy agent, eg. 
doxorub icin for the purpose of 
treatment of malignant hyper  
vascularized tumour(s) by 
embolisation of vessels and 
occlusion of blood flow supplying 
malignant hyper  vascularized 
tumour(s) and as a secondary 
action, delivers/elutes a local, 
controlled, sustained do se of the 
chemotherapy agent directly to the 
tumour(s).  If the beads are sold 
separately from the 
drug, it will be 
classified as 
MEDICAL DEVICE  
 
If the beads and drug 
are packaged and 
sold together, it will be 
classified as Drug -
Medical  Device 
combination product 
regulated as DRUG  MDA  
 
 
 
 
NPRA  
2. Drug - Delivery 
Products Regulated 
as Drug Products  
(eg. insulin prefilled 
pen/ syringes, asthma 
inhalers, intrauterine 
contraceptives whose 
primary purpose is to 
release progestogens)  To administer pharmacologica lly 
active substance  Drug -Medical  Device 
combination product 
regulated as DRUG  
 
NOTE:  
The device 
component will be 
regulated on a case to 
case basis.  NPRA  
 
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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 Table 2     :  Example Of Medical De vice-Drug Combination Product  
                      Classifica tion  
 
NO PRODUCT  INTENDED PURPOSE/ 
INDICATION AND MODE OF 
ACTION (MOA)  CATEGORY  CUSTODIAN 
AGENCY  
1. Soft tissue filler/ 
Dermal filler  To correct cutaneous contour 
deformities of the skin (e.g., 
moderate to severe facial wrinkles 
and folds such as nasol abial folds, 
scars), particularly in cases of 
aging or degenerative lesions.  
 MEDICAL DEVICE  
(If it incorporates an 
ancillary local 
anaesthetic  eg. 
lidocaine, it will be 
classified as a 
Medical  Device -Drug 
combination product 
regulated as 
MEDICAL  DEVICE)   
MDA  
2. Synthetic fluid tissue 
reconstructive 
material  As a submucosal implant in the 
urinary tract for urinary 
incontinence or vesicoureteral 
reflux.  
 
It may also be injected into the 
vocal cords to treat the effects of 
paralysis, atrophy, or scarring. 
After application, this device 
cannot be reused.  
 MEDICAL DEVICE  
(If it incorporates an 
ancillary 
pharmacologically 
active substance eg. 
local anaesthetic such 
as lidocaine, it will be 
classified as a 
Medical  Device -Drug 
combination product 
regulated as 
MED ICAL  DEVICE)  
3. Dental Products   
 i. Root canal 
filling 
incorporating 
antibiotic  To seal the canal and disinfect the 
dentinal walls by diffusing through 
dentine. The antibiotic provides 
ancillary actions as bactericidal 
antibiotic and anti -inflammatory Medical  Device -Drug 
combination product 
regulated as 
MEDICAL DEVICE  MDA  Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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 NO PRODUCT  INTENDED PURPOSE/ 
INDICATION AND MODE OF 
ACTION (MOA)  CATEGORY  CUSTODIAN 
AGENCY  
 agent to assist in reducing pain 
and in maintaining a bacteria -free 
environment within the root canal.  
4. General Purpose 
Surgical or Barrier 
Drapes  
(A sterile protective 
covering made of 
natural or synthetic 
materials, or both.)  To isolate a site of surgical  incision 
or a surgical  field from 
contamination (e.g., microbial, 
substance) in various clinical 
settings (e.g., in an operating room 
or catheterization laboratory). The 
device may also be used to protect 
a patient from heat/flame during a 
surgical  procedure. This is a 
reusable or single use device.  
 MEDICAL DEVICE  
(If it incorporates an 
ancillary 
pharmacologically 
active substance, it 
will be classified as 
Medical  Device -Drug 
combin ation product 
regulated as 
MEDICAL DEVICE)  MDA  
5. Drug -Eluting Stents 
(DES)  For use in angioplasty or coronary 
stenting procedures.  Medical  Device -Drug 
combination product 
regulated as 
MEDICAL DEVICE  MDA  
6. Drug -Eluting Beads  
(Produced from 
biocompatible  polyvinyl 
alcohol hydrogel  
modified with 
sulphonate groups  in 
phosphate buffered 
saline.)  
 It is an embolic agent which is 
intended to be loaded with a 
chemotherapy agent, eg. 
doxorubicin for the purpose of 
treatment of malignant hyper  
vascularised  tumour (s) by 
embolisation of vessels and 
occlusion of blood flow supplying 
malignant hyper  vascularized 
tumour(s) and as a secondary 
action, delivers/elutes a local, 
controlled, sustained dose of the If the beads are  sold 
separately from the 
drug, it will be 
classified as 
MEDICAL DEVICE  
 
If the beads and drug 
are packaged and 
sold together, it will be 
classified as       
Drug -Medical D evice  
MDA  
 
 
 
 
NPRA  Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
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 NO PRODUCT  INTENDED PURPOSE/ 
INDICATION AND MODE OF 
ACTION (MOA)  CATEGORY  CUSTODIAN 
AGENCY  
chemotherapy agent directly to the 
tumour(s).  combination product 
regulated as DRUG  
7. General -body orifice  
lubricant  
incorporating an  
ancillary local  
anaesthetic  
(e.g.lidocaine)  Lubricant intended to facilitate 
entry of a diagnostic or therapeutic 
device into a body orifice by 
reducing friction between the 
device and the body;  
Lubricant during catherisation, 
probing, endoscopy , changing 
fistula catheters,  intubation,  and 
prevention of iatrogenic injuries to 
the rectum and colon.  Medical Device -Drug  
combination  product 
regulated  as 
MEDICAL  DEVICE  
 
 MDA  
8. Enteral Feeding Kit 
(containing Iodine Pack 
drug)  A colle ction of sterile devices that 
includes tubing and other materials 
intended to administer nutrient 
liquids directly into the stomach, 
duodenum, or jejunum of a patient 
by means of gravity or an enteral 
pump.  Medical  Device -Drug 
combination product 
regulate d as 
MEDICAL DEVICE  MDA  
 
*Note : Table  1 and Table 2 are examples of combination product classification. These examples are non -exhaustive.  
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
24 
 APPENDIX 2: ANCILLARY MED ICAL DEVICE DOSSIER    
              REQUIREMENT FOR DRUG -MEDICAL DEVICE  
              COMBINATION PRODUCT  
The following classification for the ancillary medical device component based on the risk 
classification of medical device shall be required fo r the submission of the dossier : 
a. Class B  
b. Class C  
c. Class D  
 
Refer to MDA/GD -04 The Rule of Clas sification for General Medical Device . 
Table 3: General Requirements for Ancillary Medical Device Dossier  
Part Section  Level Of Risk Classification Of 
Ancillary Medical Device Component  
  Class B  
(Low -
Moderate 
Risk)  Class C  
(High -
Moderate 
Risk)  Class D  
(High Risk)  
 
1 Executive Summary  √ √ √ 
 a) An overview which covers an 
introductory descriptive information on  the 
medical device, the  intended uses and 
indications for use of the  medical device, 
novel features and a synopsis of the 
content of the CSDT;   √ √ √ 
 b)Commercial marketing history which 
covers the list of countries where  the 
medical device is marketed and the dates 
of introduction into those  countries  √ √ √ 
 c)Intended uses and indications in its label  √ √ √ 
 d)List of regulatory approval  or marketing 
clearance obtained including  the 
registration status, intended use and √ √ √ Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
25 
 indications of the medical device in other 
countries; copies of certificates or approval 
letters from each country and declaration 
on labelling, packaging and instruction s  
for use  
 e)status of any pending applications for 
regulatory approval or marketing  
clearance  X X √ 
 f) important safety and performance 
related information,  which shall  include :     
 (i)  summary of reportable adverse events 
and field corrective action s;  √ √ √ 
 (ii)  a description of the medical device if 
the medical device contains animal or 
human cells, tissues and/or derivatives 
thereof, rendered non -viable cells, tissues 
and/or derivatives of microbial or 
recombinant origin and/or irradiating 
comp onents, ionising or non -ionising (if 
applicable)  √ √ √ 
2 Relevant essential principles and rule used 
to demonstrate conformity * √ √ √ 
 
*note :  The Essential Principles And Rule Used To Demonstrate Conformity shall be prepared in a form of a checklist tha t is 
in accordance with Schedule 1, Appendix 1 of Medical Device Regulation 2012. Example of Essential Principles 
Conformity Checklist can be found in Schedule 2, Table 1 of Medical Device Regulation 2012)  
 
Ancillary Medical Device components that have be en approved by recognized countries as 
specified in Circular Letter No. 2 Year 2014 are allowed to undergo Conformity Assessment 
by way of Verification prescribed in the Circular Letter.  Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
26 
 APPENDIX 3: ANCILLARY DRUG DOSSIER REQUIREMENT FOR  
          MEDICA L DEVICE -DRUG COMBINATION PRODUCT  
 
Part I: General Information  
No. Section A: Combination Product Particulars  
1. Combination Product Name  
2. Name & Strength of Active Substance and Excipient  
3. Dosage Form  
4. Product Description  
5. Pharmacodynamics  
6. Pharmacokinetics  
7. Indication  
8. Recommended Dose  
9. Route of Administration/Mode of Delivery  
10. Contraindication  
11. Warning and Precautions  
12. Interaction with Other Medicaments (If Applicable)  
13. Pregnancy and Lactation (If Applicable)  
14. Side Effects (If Applicable)  
15. Symptoms and Treatment of Overdose (If Applicable)  
16. Storage Condition (If Applicable)  
17. Shelf Life (If Applicable)  
18. Declaration of human/ animal origin (If Applicable)  
No. Section B:  Drug Product Formula  
1. Batch Manufacturing Formula  
No. Section C: Mock -up Label  
1. General Labelling Requirement “Controlled Medicine/ Ubat  Terkawal”  
(for Scheduled poison only unless exempted)  
2. Specific labelling requirement as stated in DRGD (if applicable)  Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
27 
  
PART II: Q UALITY  OF DRUG COMPONENT  
1. Information on Development Studies  
2.     Manufacturing Process and Process Controls  
3.     Control of Excipients (if applicable)  
 a. Specifications of Excipient  
 b. Justification of Specifications (if applicable)  
4. Control of Drug Substances  
 a) Nomenclature, Structure of Drug Substance, General Properties  
 b) Manufacturer Name and Address  
 c) Description of Manufacturing Process and Process Controls (only for biologic 
component)  
 d) Controls of Materials (only for biologic component)  
 e) Controls of Critical Steps and Intermediates (only for biologic component)  
 f) Process Validation and/or Evaluation (only for biologic component)  
 g) Manufacturing Process Development (only for biologic component)  
 h) Elucidation of Structure and Characteristi cs(only for biologic component)  
 i) Impurities (only for biologic component)  
 j) Specifications  
 k) Batch Analysis (only for biologic component)  
 l) Certificate of Analysis for TWO batches  
 m) Justification of Specifications (only for biologic component)  
 n) Referenc e Standards or Materials (only for biologic component)  
 o) Container Closure System (only for biologic component)  
 p) Stability (only for biologic component)  
PART III: NON CLINICAL DOCUMENT  
(Applicable only to New Chemical Entity and Biologic Component)  
 Section A: Table of Contents  
No. Section B: Nonclinical Overview  
1. Overview of the Nonclinical Testing Strategy  
2. Pharmacology  
3. Pharmacokinetics  Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
28 
 4. Toxicology  
5. Other Non-Clinical  Study  
6. Integrated Overview & Conclusions  
7. List of Literature Citations  
No. Section C: Nonclinical Written and Tabulated Summaries  
No. Section D: Nonclinical Study Reports  
No. Section E: List of Key Literature References  
PART IV: CLINICAL DOCUMENT  
(Applicable only to category New Chemical Entity and Biologic Component)  
No. Section A: Table of Contents  
No. Section B: Clinical Overview  
1. Product Development Rationale  
2. Overview of Biopharmaceutics  
3. Overview of Clinical Pharmacology  
4. Overview of Efficacy  
5. Overview of Safety  
6. Benefits & Risks Co nclusions  
No. Section C: Clinical Summary  
1. Summary of Biopharmaceuticals Studies and Associated Analytical Methods  
2. Summary of Clinical Pharmacology Studies  
3. Summary of Clinical Efficacy  
4. Summary of Clinical Safety  
5. Synopses of Individual S tudies  
No. Section D: Tabular Listing of all Clinical Studies  
No. Section E: Clinical Study Reports  
 
 
 
 
 
 
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
29 
 
 
 
 
 
 
 
APPLICATION  FORM  FOR  ENDORSEMENT  LETTER  OF ANCILLARY  COMPONENT   
FOR  THE REGI STRATION  OF COMBINATION  PRODUCT  
CHECKLIST FOR  SUBMISSION  
 
DOCUMENTS  COMBINATION PRODUCT   Please tick if the 
document is 
attached  DRUG - 
MEDICAL DEVICE  MEDICAL DEVICE -
DRUG  
Ancillary  Medical  Device  Dossier   
 
(Appendix  2 of Guideline  For 
Registration  of Drug -Medical  Device  
and Medical  Device -Drug  
Combination  Prod ucts)   
 
√  
(not required for 
ancillary medical 
device Class A)  X  
Ancillary Drug Dossier  
 
(Appendix  3 of Guideline  For 
Registration  of Drug -Medical  Device  
and Medical  Device -Drug  
Combination  Products ) X √  
Report and Certificate of Medical 
Device Safety and Perf ormance 
Assessment (CAB)  √ X  
Product catalogue  √ X  
For ancillary medical device 
Class A with measuring function 
and calibration and metrology 
report shall be provided.  √ X  
For ancillary medical device 
Class A supplied sterile, 
validation report shal l be 
provided.  √ X  
 
 
 
 
 
 
 
 Appendix 4  
KEMENTERIAN KESIHATAN MALAYSIA  
Ministry of Health Malaysia  
Portal: www.moh.gov.my  
Email: kkm@moh.gov.my                                                                                                Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
30 
  
 
The form and supporting documents can be sent either via email  (in PDF format ) or post to:  
 
For Ancillary  
Medical Device Components  For Ancillary  
Drug Components  
Chief Ex ecutive,  
Medical Device Authority,  
Level 5, Menara P risma,  
Persiaran  Perdana, Presint 3,  
62675 Putrajaya.  
 
E-mail: mdb@mdb.gov.my   
Secretary,  
Drug Control Authority,  
National Pharmaceutical Regulatory 
Agency,  
Lot 36, Jalan  Universiti,  
46200 Petaling Jaya, Selangor.  
 
E-mail: helpdesk@npra.gov.my  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
31 
 Please complete  all information requested . All fields  are mandatory  unless  stated  otherwise . 
1. *APPLICANT DETAILS  
Name of Applicant:  
NRIC No. / Passpor t: Designation:  
Name & Address of Company:  
 
 
 
ROC No.:   
City:  State:  
Telephone No.:  Fax No.:  
Email Address:  
Role of Applicant:   
 
 Product Registration Holder  
 Manufacturer  
Establishment License N o.: 
 Authorized Representative  
Establishment Li cense N o.: 
 Others ( please specify ): 
*Note: The application for obtaining endorsement letter and combination product registration must be  
submitted by the same applicant  
2. COMBINATION PRODUCT DETAILS  
Please provide product packaging label, product catalo gue and product insert  
 Drug -Medical Device  
 Medical Device -Drug  
Product Name:  
 
 Manufacturer’s Name:  
Brand/Model:  
Product Description:  
 
 
Intended Use/Indication:  
 
 
 
 
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
32 
 3.   ANCILLARY MEDICAL DEVICE DETAILS  
(Only applicable to Drug -Medical Device  Combination Product)  
Name of Medical Device:   
Medical Device Grouping :  
Medical Device 
Description:   
Brand/Model:   
Intended use of the device:   
Manufacturer's  Name :  
Class  : 
(According  to Guidance  
Document  GD-04: The Rules  of 
Classification  For General  
Medical  Devices)   
Grouping  List : (Not Applicable to single medical device ) 
 
No. Name of device, accessories, 
constituent -components, or articles 
as per product label:  Model  Device Description  
  
 
   
  
 
   
  
 
   
  
 
   
 
Note: If more than one (1) single medic al device, please fill out in a separate sheet.  
 
4.   ANCILLARY  COMPONENT  DETAILS   
 Please provide details of the ancillary component according to the following:  
 
-       Ancillary Medical Device Dossier (refer Appendix 2 of Guideline For Registration of Drug - 
         Medical Device and Medical Device -Drug Combination Products ) 
-       Ancillary Drug Dossier (refer Appendix 3 of Guideline For Registration of Drug -Medic al Device  
         and Medical Device -Drug Combination Products )  
 Guideline For Registration Of Drug -Medical Device And Medical Device -Drug Combination Products  
 
33 
  
5.   ATTESTATION & DECLARATION  
 
I, <Name of applicant >, ID < NRIC No. / Passport >, on behalf of < Name of company>  
the product holder/manufacturer/authorize representative  of this ancil lary component,  
hereby declare that :  
 
 
(tick where applicable)  
        Drug -Medical Device : 
i.  This/these ancillary medical device(s) component is/are according to the definition 
of medical device set out in Section 2, Medical Device Act 2012 (Act 737) .  
ii. The device(s) conform(s) to all relevant essential principles for safety and performance, set 
out in the Appendix 1 of Third Schedule of the MDR 2012.  
 
        Medical Device -Drug :  
i. This ancillary drug component is according to the definition of d rug set out in 
Control of Drugs and Cosmetics Regulations 1984 which is promulgated under 
Sales  of Drugs Act1952.  
 
 
 
I hereby attest that the information and attac hment provided on this form are  accurate, correct, 
complete and current to this date.  
 
 
 
 
Signature:  
 
 
Applicant’s Name:  
Designation :   
Date :  
Company stamp :