Frequently Asked Questions - All FAQs

Please refer to document:
MDA/GL No. 2  - How to apply for establishment License under medical device act 2012 ( Act 737)

Please refer to document:
MDA/GL/004 - Application For Renewal Of Establishment License

All establishments, ie manufacturer, authorised representative (AR), importer and distributor must apply for establishment licence. However, only manufacturer and AR need to apply for medical device registration.

A distributor is a person or company appointed by an AR (for medical device manufactured in foreign country) or a manufacturer (for locally manufactured medical device) to further medical devices registered by the AR or the manufacturer into the Malaysian market. A distributor shall only distribute registered medical devices authorized and on behalf of the AR or the manufacturer. A distributor shall obtain an establishment license to conduct its activity.

A distributor is a person or company appointed by an AR (for medical device manufactured in foreign country) or a manufacturer (for locally manufactured medical device) to further medical devices registered by the AR or the manufacturer into the Malaysian market. A distributor shall only distribute registered medical devices authorized and on behalf of the AR or the manufacturer. A distributor shall obtain an establishment license to conduct its activity.

There is no issue if the name of the distributor differs with the name of the manufacturer. However, an AR cannot be the brand owner.

Various people or entities who are responsible for procurement, transportation, delivery, storage, device tracking, installation, commissioning, service, maintenance and calibration, need to be appropriately managed and regulated to ensure safety and performance of medical devices at the point of use. The level of risks associated with these activities may be of similar degree as those in the manufacturing environment and the lack of control over these activities may affect safety and performance of the devices. GDPMD specifies the requirements for a quality management system (QMS) to be established, implemented and maintained by an establishment in carrying out activities in medical device supply-chain to comply with medical device regulatory requirements as stipulated in Act 737 and its subsidiary legislations. GDPMD requires an establishment to demonstrate its ability to maintain quality, safety and performance of medical devices in compliance with the regulatory requirements throughout the supply-chain. The requirement for GDPMD is stipulated as the QMS requirement for those involved in medical device supply chain, namely the AR, importer and distributor as required para 11 of Third Schedule of MDR2012.

GDPMD is a requirement for establishment licensing of distributor. It is a type of QMS to ensure the safety

and performance throughout the medical device supply chain. The GDPMD will be assessed and certified by

the CAB. The certificate issued by the CAB shall be submitted as part of the requirements for establishment

license application.

Only certain non-confidential information on licensed establishments and registered medical devices will be made available for public access. Sections 67, 68 and 69 of Act 737 and Regulations 21 and 22 of MDR2012 give the provisions on how the Authority shall handle the information.

No, as long as they do not involve in any activities related to distribution. Tendering agent are strictly for the purpose of procurement with the government hospital

You may asked for the copy of establishment licensing certificate directly from your manufacturer/ Authorized representative (AR) / distributor. It is a requirement for Ministry of Health procurement division to ascertain that this products are from a licensed establishment and registered. MDA will not provide any letter for tendering agent. If they are still facing a problem, the tendering agent may call directly to MDA.

Requirement for CAB recognition must be from a local CAB in Malaysia that are registered under Section 10, Act 737.

For manufacturer, it is required to have ISO 13485, not GDPMD

Please write an official letter to MDA to notify us on this

Establishment can apply establishment license once they get provisional certificates. Establishment need to update MDA once they get full certificates.

If the distributor is not licensed, then, as AR, you are responsible to not appoint the establishment as your distributor.

If our Singapore office staff is handling everything in Singapore, is this acceptable? Answer If the medical device is place in Malaysia market, then it is subjected to Act in Malaysia. AR must have licensed and domicile in Malaysia

MDA will refer to legal manufacturer only.

Answer MDA will take action to the individual involve, not only the establishment under Malaysian act

No, you have to get the scope for implantable

Process output for establishment license for 2015 KPI – 21 working days with complete application

Yes, you still can do the placement in Malaysia market and the medical device are responsible by the Authorised Representative

AR license can be used to represent many different manufacturer and many products; However, only one (1) product must be represent by one (1) AR

Have to write to MDA and application will be open for changes. In future we will come out with system that will allow changes notification can be done anytime. Currently, write to us and MDA will facilitate for additional necessary changes. If changes of certificate, the latest certificate must be submitted to MDA. E.g. changes of manufacturing sites for GDPMD/ISO 13485, certificate must be submitted to MDA together with the application for amendment.  

The system is still on-going process of upgrading. So, it will be listed on the website once the system is ready.

Contract manufacturer only doing manufacturing for other brand owner but didn’t own the brand. Criteria for manufacturer: Brand owner; and Do manufacturing activities themselves or outsource to OEM

AELB licensed for Act 304 and for MDA, Act 737. For radiation apparatus such as x-ray, it is consider as medical device. Thus, the company need to have a licensed and registered the medical device under MDA.

It can be treated as one and it can be combine in the certification of ISO 13485- during certification process CAB have to access all the plants and covered under 1 certificate

Refer to Act 737; Assessment procedure must be carried out by a registered CAB.

Need to have the establishment license. To comply with the requirement you have to get the GDPMD certificate. As a distributor, you need a letter of authorization from the AR or Manufacturer. U also have to keep the distribution record and you will be the first point of complaint and after that you have to pass it to the AR. AR can have many distributor around Malaysia. As a distributor no need to apply product registration. MDA will know what types of product that distributor sell under AR.

AR, distributor and importer must be certified on GDPMD

The different between retailer and distributor, the AR must appoint you as the distributor whereas for retailer like a pharmacy outlet didn’t need the authorization from AR. Distributor need authorization letter and have a lot of stock. The concept we have in our law is the manufacture can appoint distributor. Whoever appointed, it is a distributor and after distributor is no more. Once distributor distribute to other company that is not distributor

A part of distributor responsibilities, it must make sure that reseller/retailer is operating with the requirement of the law. For example, they can ask you to certify for GDPMD but not a purpose of obtaining the licence. Distributor must make sure that product safe until it reach to consumer. If anything wrong to the product, the distributor will take the responsibilities. If distributor cannot control the reseller, then the reseller can obtain GDPMD because they will be audited and to ensure the product in a good condition.

The product already sold to the user, so the user keeps their stock in the central store; there are not distributor responsibilities anymore. The second level and third level are not covered by the Law.

Definitely one brand for one AR, in future the system will able to know it and alert MDA. At these moment, custom department will know, you have to show a letter to prove that you an AR. We will give a licence and list of products. If you cannot show a letter, custom will hold your goods. If somebody else break the law, they declare that goods not a medical device, you should inform us, then our enforcement will come

You need to tell us if affect your GDPMD certificate or not, for example previously you are distributing condom, catheter and glove. Suddenly IVD reagent, the requirement for IVD reagent storage and glove will be different so you need to tell us the new GDPMD cover the new product. You have to get confirmation from CAB. CAB will give you report and you need to submit a letter to MDA. Then we will put it in the system your new role.

COVID Self-test kit can only be sold by registered pharmacies and healthcare facilities.

Retailers must be authorized to sell the registered OTHER medical devices by the distributor, and only home use devices can be sold to the general public through retailers.

Manufacturer can also be distributor of its own medical device. ISO 13485 is sufficient if it is for the medical device it manufactures.

Distribution is an important activity in the integrated supply-chain of medical device. The activities carrying out by the establishment shall be in accordance with GDPMD throughout the supply-chain of medical device. A retailer that warehouses medical devices need to be under the purview of the distributor and the GDPMD of the distributor will require all storage facilities to be audited.

All registered medical device shall comply with labelling requirements as per MDA/GD/0026. The registered medical device shall be labelled with Malaysian medical device
registration number.

Medical device registration number shall be available on the outer box/external packaging. A search can also be made via Medical Device Authority Register (MDAR) mdar.mda.gov.my

We wish to inform that we have received applications from several organisations to become registered conformity assessment body (CAB) under the Medical Device Act 2012 (Act 737). Currently we are in the midst of evaluating these applications.

However, in the meantime, we notice that some companies are offering training on regulatory requirements of Act 737 including GDPMD. We would like to emphasise that any regulatory training under Act 737 is part of MDA Training Programme. We have never given any authority to anyone or any company to conduct such training and we shall not be liable for any inaccuracies or misinterpretations of the contents of the training conducted by parties other than MDA.

List of Registered Conformity Assessment Body (CAB)

Any regulatory training under Act 737 is part of MDA Training Programme. MDA has not authorize any party to conduct such training and MDA shall not be liable for any inaccuracies or misinterpretations of the contents of the training conducted by any party other than MDA.

List of Registered Conformity Assessment Body (CAB)

Please click link below to check list of registered Conformity Assessment Body (CAB): 

https://mda.gov.my/industry/conformity-assessment-body-cab/status.html

Applicants may begin to register now or within 6 months of the SA/CA approval letter's expiration date.

• Electronic IFU (e-IFU) is eligible for devices that are limited to those intended for use by professional users only. 
• Users should always have the choice to obtain the content of the eIFU in paper form on request, without undue delay or within the time period specified in the risk assessment, and at no additional cost.
• For information downloadable from the internet, the internet web address shall be clearly printed on the physical label of the device and displayed in such a manner that highlights to the user its purpose. The manufacturer /AR shall ensure that the electronic label is identical with the printed IFU approved in the product registration.
• Manufacturers shall conduct and document a risk analysis for implementation of electronic IFUs and maintain records of this analysis. Specific points to address include:

1. 1. Does the intended user have the required level of experience and the means to use the electronic IFU (e.g. a computer with internet access at or near the device’s point of use, CD/DVD Drive or a compatible web-browser)?
   2. Are there back-up methods for accessing the electronic/hard-copy IFU?
   3. Are there processes in place to ensure ongoing security of electronic IFU?

• Manufacturers shall have defined procedures and processes for the establishment and revisions to electronic documents.
• Paper-form IFU is required and additional electronic IFU is optional for home use devices. 

Note: Any changes to the electronic label shall comply with the specified requirements in Guidance on Change Notification for Registered Medical Devices (MDA/GD/0020).

• E-IFU is eligible for medical device intended for use by professional users only. 
• Paper-form IFU is required and additional electronic IFU is optional for home use devices. 

It is not part of labelling.

AR information and registration number shall be on the packaging where the information can be accessed at the point of receiving by the customers/users.

• Overlabelling using stickers is allowed, as long as there is no over labeling on the lot/batch or serial number, date of manufacturing and date of expiry.

It is allowed to have other regulatory approval information in the labelling.

-AR details
 -Registration number

• For new products registered, labelling include AR details and Registration number do not require change notification. The labelling with this information shall also submitted during Re-registration.

Product manual is recommended to be in printed form. However, electronic form is allowed to be provided subject to the following conditions

• Manufacturers shall conduct and document a risk analysis for implementation of electronic manuals and maintain records of this analysis. Specific points to address include:

1. 1. Does the intended user have the required level of experience and the means to use the electronic  (e.g. a computer with internet access at or near the device’s point of use, CD/DVD Drive or a compatible web-browser)?
   2. Are there back-up methods for accessing the electronic/hard-copy manuals?
   3. Are there processes in place to ensure ongoing security of electronic manuals?

• Manufacturers shall have defined procedures and processes for the establishment and revisions to electronic documents.

• The manufacturing date is not necessary to be included in all labelling. However, the labelling shall consist of at least one of the information below (refer to guidance document labelling clause 4.8 b.):-

1. 1. An indication of batch code/lot number/serial number; 
   2. Expiry date;
   3. Shelf life; or
   4. Manufacturing date

• The new AR need to relabel with new AR details in the labelling of stocks taken from old AR before placing them in the market.

• The products needs to comply with labelling requirements of the importing countries.

• All the information in the labelling need to be translated into Bahasa Malaysia for home use device except for brand name, proper nouns and words that are the same in both languages.

• If the accessory is supplied separately, a separate labelling shall be provided

• Manufacturing date: Day, Month and year, if only the manufacturing date is provided in the labelling. If other information such as lot/batch or serial number or expiry date has been provided, the manufacturer may decide to write the manufacturing date either in full (dd/mm/yyyy) or month and year (mm/yyyy)
• Expiry date: at least as the year and month 

• Additional labelling on Medical Device Registration Number, AR information, and Bahasa Malaysia translation does not require approval from the manufacturer.

1. Berkaitan pernyataan "KEMENTERIAN KESIHATAN MALAYSIA", adakah pernyataan ini dibenarkan pada label produk jika kami menyalurkan produk ini ke hospital-hospital swasta, farmasi swasta dan lain-lain institusi selain hospital-hospital awam?. Adakah penggunaan pernyataan tersebut merupakan suatu endorsement dan larangan dalam akta peranti perubatan?

 2. Adakah penggunaan singkatan 'KKM' dibenarkan pada label produk jika ia disalurkan pada sektor swasta?adakah singkatan ini merupakan satu endorsement?

 3. Berkaitan isu endorsement apakah contoh-contoh endorsement yang dibenarkan dan tidak dibenarkan?

• Kegunaan nama KKM atau MDA sudah melambangkan “endorsement” dan penggunaanya tidak dibenarkan.
• Untuk pembekalan kepada KKM jika ada arahan untuk pembekalan, adalah dibenarkan untuk menggunakan perkataan “Kementerian Kesihatan Malaysia”.

• Halal logo is not a requirement for medical device labelling. You may chose not to put it in. However if you label your product with a halal logo, you will need Halal certification first from JAKIM.

• Yes. The enforcement will start from 5th August 2021. Sufficient transition of 5 years was given based on circular 4/2016 and 5/2018.

No

• The original labelling together with registration number shall comply with labelling requirements.

• Yes, however, the labelling requirement need to follow the labelling requirement of the country of import.

• No

• Yes

• The establishment is given transition period of 6 months after medical device registration to include medical device registration number in its labelling.

• All labelling information has to be supplied with the medical device. If several medical devices are supplied in a box to a specific customer such as a healthcare facility for its consumption, the labelling may only be provided with the box. However, if for example, the medical devices are supplied in a box and supplied to a healthcare facility or a pharmacy so that it is to be sold or given to individual patient or customer, then labelling shall be provided with the individual medical device.

Yes. Refer definition below for home use medical device.

• A home use medical device is a medical device labelled for use in any environment outside a professional healthcare facility and intended for use by healthcare professionals and/or lay persons. This includes but is not limited to outdoor environments, office environments, schools, vehicles, emergency shelters, and independent living retirement homes.

Note 1: Lay person includes patient (care recipient), caregiver (includes non-healthcare professionals), or family member that directly uses the device or provides assistance in using the device.

Note 2: A home use medical device requires adequate labelling for the user and may require training for the user by a healthcare professional in order to be used safely and effectively.

Yes. Refer definition below for home use medical device.

• A home use medical device is a medical device labelled for use in any environment outside a professional healthcare facility and intended for use by healthcare professionals and/or lay persons. This includes but is not limited to outdoor environments, office environments, schools, vehicles, emergency shelters, and independent living retirement homes.
• Note 1: Lay person includes patient (care recipient), caregiver (includes non-healthcare professionals), or family member that directly uses the device or provides assistance in using the device.
• Note 2: A home use medical device requires adequate labelling for the user and may require training for the user by a healthcare professional in order to be used safely and effectively.

• These information shall be available on the outer box/external packaging. The manufacturer /AR may decide whether or not to include these information again in the IFU.

• The labelling is part of activity by the manufacturer. For AR that does additional labelling to comply requirements of MDA/GD/0026 shall get approval for labelling from manufacturer.

Face masks are regulated as medical devices if there are claims or descriptions by the manufacturer that makes the mask or respirator a medical device as defined in Section 2 of Act 737. Generally, face masks fall within this definition are intended for prevention of the transmission of disease (including uses related to COVID-19) and for medical purpose such as for surgical, clinical or use in other health services. The details information can be referred through guidance document on medical face masks and respirator- MDA/GD/0033.

The glove is classified as medical device if the intended can fit the definition of medical device in accordance with Section 2 of Act 737.  Usually these are labelled as “surgical” or “examination” gloves.

It is in accordance with the intended use by the manufacturer and can fit the definition of medical device as stipulated in Section 2 of Act 737.

The COVID-19 rapid test kit (self-test)) is used as a self-administered screening test. It does not
replace the reverse-transcription polymerase chain reaction (RT-PCR) for COVID-19
real-time diagnostic function, but it does have the advantage of determining patient
status immediately and conveniently

A self-test is a rapid antigen test that you can carry out yourself at home while professional for use kit is in point of care settings for both symptomatic and asymptomatic people. This can help healthcare professionals identify a SARS-CoV-2 infection in people

Conditional approval application is to be submitted via email at:
using the Form A

All licensed establishments with IVD scope in GDPMD may apply

Applicant is required to submit completed copies of the following documentation:

a) Letter of Authorization from Foreign Manufacturer with list of devices;
b) Valid quality management system (ISO 13485) certificate;
c) Analytical performance report (analytical sensitivity, analytical specificity,
interference and/or other analytical tests);
d) Raw data of clinical performance full report (clinical sensitivity, clinical specificity,
method comparison- performance validation (cross table), and layman usability);
e) Medical device labelling, IFU & product brochure, text hyperlink or QR Code link
to audiovisual demonstration;
f) Disposal procedure (e.g. by providing disposable bag with disinfectant for the
disposal of the test kit, and any other instructions for disposal);
g) Methods of reporting self-test Covid-19 test result. (Positive, Negative and
inconclusive); and
h) Declaration of Conformity (refer guidance document MDA/GD/0025).

1)Submission of complete Application Form A and application fee (Bank Draft rm150)
2)The Secretariat receiving the application will send an acknowledgement to the applicant
3)Screening of Application and for incomplete applications it will be returned to the applicant for more information/documentation.
4)The application will be evaluated
a) Applications that do not meet the requirements will be rejected.
b) Applications that meet the requirements will be moved to the Expert Committee (Jawatankuasa Pakar Penilaian Akses Khas Covid-19 IVD Test Kit) Meeting.
5)Assessment by Covid-19 Expert Committee
6)Notification of Asessment Result by MDA via email
7)Evaluation of Test Kits at Testing Facilities
8)Testing facilities submit Evaluation Report to MDA
9)Decision (Endorsement by Expert Committee)
10)The applicant will be notified of the decision through email.
11)Issuance of Payment Invoice for Conditional Approval Fee (RM 1000) by MDA
12)Submission of Bank draft
13)Issuance of Conditional Approval Letter for Covid-19 RTK (self-test)?

You have to submit Clinical Performance Report:
• Clinical Sensitivity
• Clinical Specificity
• Method Comparison- Performance Validation (Cross table)
-The clinical performance of the Covid-19 RTK (self-test) by patient self-testing, and professional testing after supervised self-collection or professional collection.
-Cross table for the method comparison of Covid-19 RTK (self-test) against RT-PCR
• Layman usability

Laymen study is used to review and demonstrate the easy use of the COVID-19 Ag Rapid Saliva Test Device for self-testing. The aim is to check whether the test, including the instructions for use, is easy to understand and in use and whether it can be recommended for personal use

The application being rejected if full performance report/Clinical study report does not meet performance criteria.

RTK is faster and less intrusive than a Polymerase Chain Reaction (PCR) test. This makes it easy for the public to use to test themselves if needed. In general, RTK have a sensitivity (ability of a test to identify patients with the disease) of about 80% for cases with higher viral loads and a specificity (ability of a test to identify patients without the disease) range of 97-100%. As the sensitivity and specificity of RTKs are lower as compared to PCR tests, if you test RTK-positive or invalid twice, you will need to follow up with a confirmatory PCR test at clinic. You should not repeat the RTK. Even if you do test RTK-negative in the repeated test, it may be a false negative result and hence you need to go for a confirmatory PCR test.

Yes, as long as it received conditional approval

The COVID-19 RTK (self-test) kit granted conditional approval shall only be sold
by registered Pharmacies and healthcare institutions registered with Cawangan
Kawalan Amalan Perubatan Swasta (CKAPS).

Online sales are only allowed for registered pharmacies and health institutions and
by abiding with the manufacturer’s instructions relating to storage and delivery
conditions.

The COVID-19 RTK (self-test) kit granted conditional approval shall only be sold
by registered Pharmacies and healthcare institutions registered with Cawangan
Kawalan Amalan Perubatan Swasta (CKAPS)

MDA will issue a Conditional Approval Letter for Covid-19 RTK (self-test).

MDA regulates medical device advertisement through the Medical Device (Advertising) Regulations 2019 and Code of Advertisement (CoA) - MDA/GD/0032

Yes. Restriction for professional use medical device which is not to be sold to the general public.

The approved advertisement must have approval number

Yes, but must have authorization from the manufacturer or AR.

Advertisements for the general public to be posted, displayed or broadcasted shall include MDA advertisement approval number.

Any query or feedback can be submitted to MDA Feedback Management System (FEMES) - WEB https://femes.mda.gov.my

• RT – PCR
• POCT molecular
• RTK Ag test kits/Ag Assay/ Self-test kits
• RTK Ab / Ab Assay
• Neutralizing Ab Assay

Apply through Medcast 2.0 and follow the steps for registering COVID-19 test kits according to the MDA/GL/07 Guideline for Registration of COVID-19 Test Kits

Evaluation Timeline:

Please refer to guideline MDA/GL/07 Guideline for Registration of COVID-19 IVD Test Kits for further information on the main documents for registration, such as the CSDT, EPSP, DOC, Safety and Performance reports, Labeling/IFU/Brochure, and other related documents.

No. All COVID-19 test kits will be reviewed based on the criteria set forth by MDA with the help of expert committee.

• The manufacturer's performance report failed to meet the requirements.
• There is insufficient information in the Performance data.
• The manufacturer used insufficient sample size for positive and negative tests.
• The test result did not meet the MDA's minimum cut-off for sensitivity and specificity, which had been conducted at a local testing facility.

Yes, applicants may re-apply in Medcast 2.0 for the same lot number / batch number, with a new performance report.

Applicants may begin to register now or within 6 months of the SA/CA approval letter's expiration date.

No, MDA will send an evaluation letter for the test kit. Any report submitted to the testing facility by the applicant without MDA's Evaluation letter will be rejected.

Please contact MDA (registration unit) for more information about the test's technology and principles. Make an appointment to meet with the IVD registration officers if necessary, you refer the directory in MDA’s portal to contact them. (Staff Directory)

If there is a new lot number, change notification application is required to be submitted by the applicant under:

Category 2

5.5.2 Changes in design or specifications of a registered medical device

(c) All changes in specifications (including shelf life and stability) of a registered medical device.

Evaluation letter will be provided via email for evaluation of the new lot number in testing facilities.

Professional test kits:

Performance report for the new lots should be provided. For professional test kit, new lot number will be evaluated by the manufacturer and the report of performance shall be notified to MDA.

Self-test kits:

For every new lot number, Lot to lot Evaluation is required.

It is not compulsory for the Covid-19 test kit to have obtained reference country approval. However, Approval from 5 reference countries should be stated in the CSDT under Executive Summary (Commercial Marketing History) and the related approvals should be uploaded as annexes.

The establishment should identify their scenario and provide the appropriate documentation before submitting the application.

Refer Table 3 Documents/Information required to be submitted in MDA/GL/07

Yes, all Conditional Approval and Special Access application submitted by 31^st January 2022 and currently undergoing evaluation will be processed till the end.

Yes, the COVID-19 test kit will be registered in Medcast 2.0 system, a registration certificate and registration number will be issued and the validity is 5 years.

Yes, multiple AR is allowed for the registration of COVID-19 test kit on Medcast 2.0. The establishment should provide Letter of Authorization (LoA) from the manufacturer.

No. New brand requires new registration application. New proprietary name or brand shall be applied separately.

Any Adverse Event in regards to the test kit should be reported to PMSV unit.

Answer:

COVID-19 test kits are classified as Rule 3 Class C.

Rationale:

e) in determining infectious disease status or immune status, and where there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation for the patient.

Professional and self-test kits should be registered separately.

They are different in terms of conditions of use; application should be submitted based on different requirements.

Sample of test kits shall be submitted for evaluation to MDA upon Evaluation Officer’s request.

In Medcast 2.0 for IVD applications, in section 7.0 CONFORMITY ASSESSMENT, the following should be uploaded:

• QMS/GDPMD certification
• SA and CA letter obtained (Scenario a)

• Reverse transcription polymerase chain reaction (RT – PCR)
• Rapid Test Kit Antigen (RTK Ag) /Antigen Assay
• Rapid Test Kit Antibody (RTK Ab) / Antibody Assay

Evaluation Timeline: 60 working days

Apply through Medcast 2.0 and follow the steps for registering Monkeypox test kits according to the MDA/GL/09 GUIDELINE FOR REGISTRATION OF ORTHOPOXVIRUS (MONKEYPOX) IVD TEST KITS.

Please refer to guideline MDA/GL/09 GUIDELINE FOR REGISTRATION OF ORTHOPOXVIRUS (MONKEYPOX) IVD TEST KITS for further information on the main documents for registration, such as the CSDT, EPSP, DOC, Safety and Performance reports, Labelling/IFU/Brochure, and other related documents.

Yes. It is necessary to appoint CAB to conduct conformity assessment.

• Medical devices that have been approved by regulatory authorities or notified bodies recognized by Medical Device Authority (MDA) is required to conduct conformity assessment by way of verification by any registered CAB.
• Medical devices which have not obtained any approval by regulatory authorities or notified bodies recognized by Medical Device Authority (MDA) is required to undergo full conformity assessment by any registered CAB

• The manufacturer's performance report failed to meet the requirements.
• There is insufficient information in the Performance data.
• The manufacturer used insufficient sample size for positive and negative tests.
• Clinical Studies does not meet requirements as per ISO 20916: 2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice.

Yes, applicants may re-apply in Medcast 2.0 for the same lot number / batch number, with a new performance report.

It is not compulsory for the Monkeypox test kit to have obtained reference country approval. However, Approval from 5 reference countries should be stated in the CSDT under Executive Summary (Commercial Marketing History) and the related approvals should be uploaded as annexes.

Refer Table 2 Documents/Information required to be submitted in MDA/GL/09

Yes, the Monkeypox test kit will be registered in Medcast 2.0 system, a registration certificate and registration number will be issued and the validity is 5 years.

Monkeypox test kits are classified as Rule 3 Class C.

Rationale:

e) in determining infectious disease status or immune status, and where there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation for the patient.

A Conformity Assessment Body (CAB) is an independent organization registered by the Medical Device Authority (MDA) of Malaysia to assess, audit, and verify the conformity of medical devices and establishments with the applicable regulatory requirements outlined in the Medical Device Act 2012 (Act 737) and its associated regulations.

CABs play a critical role in the regulatory framework for medical devices. Their main tasks include: (1) Conformity Assessment: CABs evaluate the technical documentation, design, manufacturing processes, and performance characteristics of medical devices to ensure compliance with the relevant standards and regulations. (2) Audits and Assessments: CABs may conduct audits and assessments of medical device manufacturers, authorized representatives, importers, and distributors to verify that they adhere to quality management systems (ISO 13485 and Good Distribution Practice of Medical Devices, GDPMD) based on specific regulatory requirements. (3) Testing and Evaluation: CABs may perform testing and analysis of medical devices to assess their safety, performance, and effectiveness. (4) Certification and Issuance of Conformity Assessment Certificates: Based on successful assessment, CABs issue Conformity Assessment Certificates, indicating that a medical device meets the required standards and regulations.

CABs offer a range of services to medical device manufacturers, authorized representatives, importers, and distributors, including: (1) Technical File Review: Reviewing technical documentation submitted by manufacturers and/or authorized representative to demonstrate conformity with regulatory requirements. (2) Quality System Audits: Auditing manufacturing and/or establishment facilities to assess compliance with quality management system standards. Testing and Analysis: Performing tests to evaluate the safety, performance, and reliability of medical devices. (3) Certification: Issuing certificates indicating that a medical device conforms to the relevant standards and regulations. (4) Assessments: Conducting assessments of manufacturing and/or establishment facilities through surveillance visits to ensure ongoing compliance.

CABs are registered by the Medical Device Authority (MDA) based on their competence, expertise, and compliance with relevant standards. The registration process involves a thorough assessment of the CAB's technical capabilities and its quality management systems.

No, while CABs play a crucial role in conformity assessment, manufacturers of Class A medical devices also have the option to self-declare the conformity of their medical devices. However, classes of B, C, and D medical devices require assessment by a CAB.

Manufacturers, authorized representatives, importers, and distributors should consider factors such as the CAB's expertise in the relevant medical device category, its valid registration status under the Act 737, and geographic coverage when selecting a CAB for assessment and certification services.

Yes, some CABs may have the capability to operate internationally and provide assessment services beyond Malaysia's borders. This is especially relevant for manufacturers seeking to distribute their medical devices in multiple countries. But to distribute medical devices on the Malaysian market, the conformity assessments must be performed by Conformity Assessment Bodies (CABs) registered under the Act 737.

The frequency of engagement with CABs depends on factors such as the type of medical device, its risk classification, and regulatory changes. Manufacturers, authorized representatives, importers, and distributor may need to engage with CABs during initial assessment, for ongoing compliance, and for recertification.

CABs may be involved in post-market surveillance activities by conducting periodic audits, assessments, and tests on medical devices that are already on the market to ensure continued compliance with regulations and standards.

The Act empowers the Medical Device Authority (MDA) to establish and maintain a register of registered CABs. This registration process includes evaluating the CAB's competence, independence, and compliance with relevant standards.

CABs can be categorized into different types based on the scope of their services. These may include conformity assessment on quality management system (ISO 13485 and Good Distribution Practice of Medical Devices, GDPMD), conformity assessment on technical documentation, or conformity assessment by way of verification.

You can verify the legitimacy of a CAB by checking the official register maintained by the Medical Device Authority (MDA). This register will provide a list of registered CABs that are authorized to perform conformity assessments under the Act 737. Link to registry: https://mda.gov.my/industry/conformity-assessment-body-cab/status.html

CABs are often required to obtain accreditation voluntarily from relevant accreditation bodies. Accreditation ensures that the CAB meets specific technical competence and operational criteria. Accredited CABs demonstrate their capability to provide reliable and accurate conformity assessment services.

While manufacturers, authorized representatives, importers, or distributors have some flexibility in choosing a CAB, it's essential to consider the CAB's specific registered scopes so that assessment to your medical device can be fulfilled.

Yes, CABs typically charge fees for their services, including assessment, testing, certification, and assessments. These fees may vary based on the complexity of the device, the scope of assessment, and other factors.

Yes, a CAB has the authority to revoke a Conformity Assessment Certificate if it becomes evident that the medical device no longer meets the required regulatory standards. This can happen due to changes in the device's design, manufacturing processes, or other relevant factors.

While it is possible to switch CABs, it's important to consider the implications of such a decision. Switching CABs mid-process may cause delays and additional costs. Manufacturers, authorized representatives, importers, or distributors should communicate their intentions clearly and ensure a smooth transition.

Yes, MDA has outlined the essential information that should be included in a Conformity Assessment Certificate. This includes details about the manufacturer, authorized representative, importer, or distributor, the device, the CAB, and references to the relevant regulations and standards.

CABs can provide guidance and support to manufacturers, authorized representatives, importers, or distributors regarding the preparation of technical documentation. However, manufacturers, authorized representatives, importers, or distributors are ultimately responsible for ensuring that the documentation accurately demonstrates conformity to regulatory requirements.

CABs themselves are subject to periodic audits and assessments by MDA to ensure their ongoing competence and compliance with registration requirements. This helps maintain the integrity of the Conformity Assessment Bodies (CABs).

Yes, individuals working within CABs, especially in roles related to assessments, testing, and quality management, are often required to possess relevant qualifications, training, and expertise in medical devices, quality systems, and regulatory compliance.

Yes, manufacturers, authorized representatives, importers, or distributors have the right to challenge decisions made by CABs if they believe the assessment was incorrect or unfair. The process for challenging such decisions should be outlined with relevant facts.

CABs primarily focus on the technical and quality aspects of medical devices. The evaluation of clinical data often falls under the purview of other regulatory authorities, such as ethics committees and regulatory agencies.

The Act may include provisions to prevent conflicts of interest within CABs, ensuring that their assessments remain impartial and unbiased. CABs are mandatorily required to maintain their independence and act in the interest of public health and safety.

While some CABs may offer consulting services, there is a potential conflict of interest if the same organization both assesses and consults on regulatory compliance. It's generally advisable for CABs to maintain a clear separation between their assessment and consulting functions.

CABs must always stay informed about updates to regulations and standards relevant to medical devices. This can be achieved through continuous training, participation in industry forums, and collaboration with regulatory authorities. Attending CAB Proficiency Trainings sanctioned by MDA is mandatory and all personnel of CABs must sit an examination and pass it to maintain their proficiency. The passing mark is set 80% and above by MDA.

If a CAB fails to meet its obligations, violates regulations, or compromises the integrity of the assessment process, MDA can take enforcement actions, including suspension or revocation of the CAB's registration.

A CAB can operate as an independent entity, but it must meet the necessary requirements for designation and demonstrate its competence and ability to carry out conformity assessments effectively.

Manufacturers can raise their concerns or complaints with MDA overseeing CABs. This may involve reporting issues related to assessment quality, professionalism, or any conflicts of interest.

CABs may offer expedited assessment services for certain urgent cases. However, these cases are typically evaluated on a case-by-case basis, and the priority is still given to ensuring the safety and efficacy of the medical device.

Yes, remote assessments may be possible in certain situations, particularly when on-site visits are not feasible or deceases outbreak. CABs should have procedures in place to ensure the effectiveness and accuracy of remote assessments and must obtain approval from MDA to proceed.

Adverse events or incidents related to medical devices are typically reported to MDA, and in some cases, to the CAB responsible for the assessment. CABs may play a role in post-market surveillance by assisting in the investigation of such events.

CABs may offer guidance and support to manufacturers, authorized representatives, importers, or distributors to help them prepare for regulatory requirements, particularly by providing insights into the type of assessments and documentation that may be reviewed by MDA during inspections. But there is a potential conflict of interest if the same CAB assesses and assists on regulatory compliance. It's generally advisable for CABs to maintain a clear separation between their assessment and assisting functions.

While manufacturers, authorized representatives, importers, or distributors may have the right to challenge an assessment's results, requesting a re-assessment by a different CAB may not be a common practice. It's advisable to follow the established appeal or dispute resolution process.

CABs may operate within no boundary in geographic regions in Malaysia, depending on their registration and capabilities. However, they must adhere to registration conditions to operate as a CAB.

While CABs primarily assess devices, some may also be involved in certifying personnel, such as medical device auditors or assessors, to ensure they possess the necessary competence, but MDA will not be liable of misinformation disseminated to their personnel on any regulatory requirements.

CABs are required to have confidentiality measures in place to protect sensitive information provided by manufacturers, authorized representatives, importers, or distributors during the assessment process. Confidentiality Declaration is required to be signed by personnel yearly basis by MDA.

Expedited assessment timelines may be offered by CABs in some cases, but this should not compromise the thoroughness and accuracy of the assessment process. MDA will not be liable on the additional fee to be imposed for such service.

Yes, CABs are generally required to maintain records of their assessment activities, including documentation related to their evaluation, testing, certification decisions, and communication with manufacturers, authorized representatives, importers, or distributors.

CABs may require manufacturers to inform them about any significant changes to the medical device's design, intended use, or manufacturing processes. Depending on the nature of the changes, a re-assessment or notification to MDA is necessary.

CABs may provide general guidance on labeling and packaging requirements, but manufacturers, authorized representatives, importers, or distributors are ultimately responsible for ensuring compliance with the specific labeling regulations outlined in the Medical Device Regulations 2012.

CABs may use various methods to verify technical documentation, including review, testing, and verification of data. Manufacturers are expected to provide accurate and complete documentation.

Yes, CABs may assess software components and digital health applications integrated into medical devices to ensure their safety, performance, and compliance with relevant standards.

No. CABs should not offer pre-assessment or consulting services to help manufacturers, authorized representatives, importers, or distributors understand the potential gaps and requirements for compliance before the formal assessment process begins.

Yes, manufacturers, authorized representatives, importers, or distributors typically have the right to appeal decisions made by CABs. The appeal process should be in lined with the MDA guidelines.

Yes, some CABs may provide training sessions or workshops to manufacturers to help them better understand the regulatory requirements and the assessment process, but MDA will not be liable of misinformation disseminated to manufacturers, authorized representatives, importers, or distributors.

CABs may assess the quality management system and processes of both the manufacturer and the third-party manufacturer (OEM or contract manufacturer) to ensure compliance with regulatory requirements.

Yes, CABs may collaborate with other international CABs for assessments that involve devices distributed across multiple countries, especially in cases where mutual recognition agreements exist. But final conformity assessment certificate and report must be issued by registered CABs under the Act 737.

CABs are subject to regular monitoring and assessment by MDA to ensure they maintain their competence and compliance with their registration scopes.

Yes. CABs may provide manufacturers with a general overview of the assessment process and requirements, but the specific requirements will depend on the type and classification of the medical device.