What is Conformity Assessment?

Conformity assessment is a systematic and ongoing examination of evidence and procedures to ensure the safety, performance, benefit and risk of medical devices. It is also to ensure manufacturing compliance to essential principles of safety and performance (EPSP) and requirements of the Medical Device Act 2012 (Act 737). The classification of a medical device determines the conformity assessment procedures to be undertaken. Conformity assessment becomes more stringent as the risk of medical device increases Conformity Assessment (Product Verification) and Full conformity Assessment.

Elements of conformity assessment

For the purpose of medical device registration, the following conformity assessment elements shall be assessed by the CAB:

a) Quality management system (QMS) - Manufacturers shall be certified with ISO 13485.
Extend of QMS certification based on risk class

• Risk Class A and B.
  the quality management system for a Class A or Class B device shall be either a full quality management system or one without design and development control, the manufacturer shall choose the one that it believes to be most suitable.
  

• Risk Class C and D.

Establish and maintain a full QMS

b) A system for post-market surveillance;

1) For Class B, C and D medical device, CAB shall ensure PMS is established, maintained and implemented by the establishment.

2) The following processes shall be documented, maintained and implemented by the establishment:
a) complaint handling;
b) distribution records;
c) mandatory problem/adverse event reporting;
d) field corrective action; and
e) recall.
f) Technical documentation; and

• i) The technical documentation provides the evidence that the medical device meets the essential principles for safety and performance (EPSP). The manufacturer shall collect and examine evidences of conformity and compile these evidences in a technical documentation.
  
• ii) The manufacturer shall also establish a summary of the technical documentation in the form of a common submission dossier template (CSDT), which is to be held or submitted, as required depending on the class of the medical device.
  
• iii) CAB determines the adequacy of the documented evidence in support of the manufacturer’s declaration of conformity to the EPSP through a review of the CSDT and technical documentation.
  

• i. CAB shall refer to ISO 16142-1 and ISO 16142-22 for selection of standards in support of EPSP. CAB shall also identify relevant established standards applicable for the medical devices within the technical area(s) they are registered for. Use of established standards to demonstrate the compliance with EPSP shall be according to the following priority:

a) Malaysian Standards (MS) and/ or International Standards (i.e. ISO/IEC/ITU);

b) Recognised Countries Standards, i.e. US, EU, Canada, Australia and Japan; and

c) Industry Standards/ Company standards.

In the case the manufacturer opts to diverse from the above hierarchy, the manufacturer shall provide valid justification for its deviation.

d) A declaration of conformity.

• i) Medical Devices manufacturers shall attest that its medical device complies fully with all applicable Essential Principles for Safety and Performance and other requirements of Act 737 and the subsidiary regulations under it, documented in a written 'Declaration of Conformity' (DOC).
  
• ii) Guidance Document MDA/GD/0025 specifies requirements on Declaration of Conformity and shall be used for this purpose.
  
• iii) The CAB shall ensure that all elements are clearly stated and/or listed and the DoC has been signed by a person from the top management of the manufacturer or a person authorised to sign on his/her behalf.
  

a) Extend of QMS certification based on risk class

• 3) Risk Class A and B
  the quality management system for a Class A or Class B device shall be either a full quality management system or one without design and development control, the manufacturer shall choose the one that it believes to be most suitable.
  

• 4) Risk Class C and D
  Establish and maintain a full QMS

Section 5 (1) of Medical Device Act 2012 (Act 737) requires a medical device to be registered under the Act before it can be imported, exported or placed in the market. For that purpose, an application for the registration of a medical device must be made according to the requirement under Act 737 and in the manner determined by the Authority in Medical Device Regulation 2012.

Starting from 1 July 2013 when Act 737 comes into effect, all medical devices to be placed market are required to be registered under the Act. The application for medical device registration shall be made to the Authority through an online, web-based system called “Medical Device Centralized Online Application System (MeDC@St)".

The term “medical device” covers any product used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or handicap but excludes drugs.

The persons responsible for registering a medical device under Act 737 are—
(i) the manufacturer of medical device as defined in Section 2 of Act 737; and
(ii) in the case of a medical device manufactured in foreign country, the authorized representative of the foreign manufacturer, as defined in Section 2 of Act 737

• (1) It is applicable to all medical devices that have been subjected to conformity assessment and approved by any of the recognised foreign regulatory authorities or notified bodies with respective approval type as shown in Table 1, except for those which are exempted from registration in Malaysia.
  

Table 1: Recognised foreign regulatory authorities and notified bodies and the respective approval types eligible for conformity assessment by way of verification process

• (2) Medical devices which have not obtained any approval by regulatory authorities or notified bodies listed in Table 1 is required to undergo full conformity assessment by any registered CAB in accordance with the requirements stipulated in Section 7(1)(a) of Act 737.

B. Legal Basis

• (3) Section 7(1)(a) of Act 737 prescribes that upon receipt of an application made under Section 6 of the Act, MDA being satisfied that the medical device has been subjected to the conformity assessment procedures to be carried out by the CAB, MDA may register the medical device for a prescribed period.
• (4) Section 10(1) of Act 737 prescribes that a CAB shall be a body registered under this Act to carry out conformity assessment of a medical device to be registered.
• (5) For the purpose of product registration, it is further required that all medical devices shall be subjected to conformity assessment to demonstrate its conformity to the requirements as specified in Third Schedule of Medical Device Regulation (MOR) 2012.

C. Eligibility of CABs to conduct verification process

• (6) Section 10 of Act 737 prescribes that conformity assessment of medical device shall be carried out by CAB. Hence, it is pertinent that the CABs shall carry out the conformity assessment with due diligence and adhering to all the regulatory requirements as stipulated in Act 737 and its subsidiary legislations. The CABs shall be independent and impartial with regards to the performance of its conformity assessment duties as stipulated in Section 10(3)(a) of Act 737 and paragraphs 9(2) and 9(7) of Fourth Schedule of MOR 2012
• (7) The following criteria shall apply for the eligibility of CABs for performing conformity assessment of a medical device by way of verification process-
  (i) For medical devices which have been subjected to conformity assessment by recognised foreign regulatory authorities in Table 1, the verification process of the said medical device may be carried out by any CABs registered under Act 737;
  (ii) Where a medical device has its conformity assessment already carried out by a recognised foreign notified body in Table 1, then the subsidiary of the foreign notified body registered as CAB under Act 737 shall not be allowed to do verification on the same medical device. However, it may be carried out by any other CABs registered under Act 737;
  (iii) Where a medical device has its conformity assessment already carried out by any other regulatory authorities recognised by MDA from time to time, then the criteria in (ii) shall apply; and
  (iv) The CABs which are eligible to conduct verification process shall have been registered with at least one scope under Medical Device Technical Area (Appendix 1 of Fourth Schedule MOR 2012). Example: A CAB with registered scope of MD 0203 may conduct verification process on a medical device under any Medical Device Technical Areas.

D. Conformity assessment elements and parameters to be verified by CAB

• (8) The parameters to be verified by CAB in its verification process shall comprise of the conformity assessment elements as stipulated in Third Schedule of MOR 2012 as follows-
• (i) Conformity assessment of quality management system;
• (ii) Conformity assessment of post market surveillance system;
• (iii) Conformity assessment of technical documentation; and
• (iv) Conformity assessment of declaration of conformity.

• (9) The extent of verification activities will depend on the class of the medical device.

E. Verification steps for Class A (active, sterile or with measuring function) medical device

• (10) Verification steps and parameters to be verified by CAB for Class A (active, sterile or with measuring function) medical device are described in Figure A and Table 2 respectively.

Figure A: Verification steps for Class A (active, sterile or measuring function) medical

Table 2: Verification steps and parameters to be verified for Class A (active, sterile or measuring function) medical device

Table 2. Conformity assessment on Class A medical devices

F. Verification steps for a Class B, C or D medical device

• (11) Verification steps and parameters to be verified by CAB for a Class B, C or D medical device are described in Figure Band Table 3 respectively.

Figure 8: Verification steps for a Class B, C or D medical device

Table 3. Conformity assessment on Class B medical devices

Table 4. Conformity assessment on Class C and D medical devices

G. Medical device registration:

What are the steps and criteria for medical device registration?

• Determine whether the product is a medical device

The determination of the product will be based on the definition of “medical device” in as specified in Section 2 of Act 737 and further elaborated in the Guidance Document on Definition of Medical Device (MDA/GD-01).

• Appropriately classify the medical device

The classification of medical device should be done according to the rules of medical device classification as specified in First Schedule of Medical Device Regulation 2012 and further elaborated in the Guidance Document on The rules of Classification for general medical devices (MDA/GD-04).

• Appropriately group the medical device

The grouping of medical device should be done according to the rules of medical device grouping as specified in Second ScheduleofMedical Device Regulation 2012 and further elaborated in the Guidance Document on Grouping of Medical Device.

• Conduct conformity assessment and collect evidence of conformity

(i) the evidence of conformity has to be collected to demonstrate compliance to applicable Essential Principles of Safety and Performance of Medical Device as specified in Appendix 1 of Third Schedule of Medical Device Regulation 2012 and further elaborated in the Guidance

Document on Essential Principles of Safety and Performance of Medical Device (MDA/GD-02);

(ii) the evidence of conformity has to be compiled according to the Common Submission Dossier Template (CSDT) as specified in Appendix 2 of Third Schedule of Medical Device Regulation 2012 and further elaborated in the Guidance Document on Common Submission Dossier Template (MDA/GD- 03);

(iii) the Declaration of Conformity according to the template in Appendix 1A of Third Schedule of Medical Device Regulation 2012 has to be duly prepared, signed and

stamped.

• Appoint CAB to conduct conformity assessment

According to 3rd Schedule of Medical Device Regulation 2012

(i) the evidence of conformity has to be verified or validated by the registered CAB;

(ii) the CAB has to issue certificate of conformity and the report upon completion of the conformity assessment.

• Apply to register medical device using MeDC@St

(i) Application for registration of medical device may be made after the criteria are met and the information and supporting documents to support the criteria are available;

(ii) Application for medical device registration shall be made via MeDC@St;

(iii) Applicant must create an account before making application via MeDC@St.

After the account have been created in the MedC@st system, the form need to be filled in and it consist of 8 parts as stated below:

(i) General information;

(ii) Information of manufacturer;

(iii) Grouping of medicaldevice;

(iv) Common Submission Dossier Template (CSDT);

(v) Supporting documents forCSDT;

(vi) Post-market vigilance history;

(vii) Declaration of Conformity

(viii) Attestation for medical device registration application

How to complete the form:

• 1. Is the medical device for export only


• 2. Is the medical device contains any active ingredient, poison or drug?


• 3. Type of medical device


• 4. Class of medical device


• 5. Classification rules


• 6. Medical device category


• 7. Medical device name


• 8. Description of medical device


• 9. Information on the product formulation (applicable for medical device contains the active ingredient/poison/drug)


• 10. Intended use of the medical device


• 11. HS code

Please provide the HS Code for the medical device, if applicable. HS Code is Harmonized Tariff Nomenclature & Coding System which was created for international use by

the Custom Department to classify commodities when they are being declared at the custom frontiers by exporters and importers. For reference of HS Codes, you may search from

Search Tariff function at JKDM HS

– Explorer Website at http://tariff.customs.gov.my.

– Download Checklist for medical device conformity assessment by CAB

For more info, please visit http://www.customs.gov.my.

• 12. GMDN code


• 13. Premarket clearance


• 14. Conformity assessment done by CAB


• 15. Information of Manufacturer


• 16. Grouping of Medical Device


• 17. Medical device grouping

• a) Please select the grouping that is applicable to your device. The grouping should be done in accordance with the Rules of Grouping as specified in the Second Schedule of the Medical Device Regulation 2012 and further elaborated in the Guidance Document on Grouping of Medical Device.


• b) Same manufacturer. Please specify whether or not constituent-components or medical devices that are grouped together are manufactured by the same manufacturer.


• c) List of Constituent-components medical devices. Please list the constituent-components or medical devices that are grouped together in fields provided. You may list all in a template provided in the link for batch uploading.


• d) Common Submission Dossier Template (CSDT)


• e) Post-Market vigilance history


• f) Declaration of Conformity

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• Contact for more details:
  Email: fleming@cciglobe.com, reecheeteo@cciglobe.com
  Tel：+(603) 5131 6160