DRAFT OF MEDICAL DEVICE GUIDANCE DOCUMENT

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November 2015 First Edition DRAFT OF MEDICAL DEVICE GUIDANCE DOCUMENT MEDICAL DEVICE CONFORMITY ASSESSMENT PROCEDURE BY WAY OF VERIFICATION PROCESS FOR

1 November 2015 First Edition DRAFT OF MEDICAL DEVICE GUIDANCE DOCUMENT MEDICAL DEVICE CONFORMITY ASSESSMENT PROCEDURE BY WAY OF VERIFICATION PROCESS FOR MEDICAL DEVICES THAT HAVE BEEN APPROVED BY RECOGNISED FOREIGN REGULATORY AUTHORITIES OR NOTIFIED BODIES Medical Device Authority MINISTRY OF HEALTH MALAYSIA

2 Content Page Preface. iii 1 Introduction 1 2 Purpose 1 3 Scope and application 1 4 Term and definitions Requirement for verification process Eligibility criteria of medical device for verification process Eligibility and liability of CABs..3 6 Verification process Verification steps for Class A (active, sterile or with measuring function) medical device Verification steps for a Class B, C or D medical device Verification steps for a Class B, C or D medical device.5 7 Report and certificate Report of conformity Certificate of conformity 7 Annex A Conformity assessment report template Annex B Certificate of conformity template ii

3 Preface This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it. This Guidance Document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following- a) Medical Device Act 2012 (Act 737); and b) Medical Device Regulations 2012; Irrespective of the requirements of this Guidance Document, MDA has the right to request for information or material, or define conditions not specifically described in this document that is deemed necessary for the purpose of regulatory control. MDA has put much effort to ensure the accuracy and completeness of this guidance document. In the event of any contradiction between the contents of this document and any written law, the latter should take precedence. MDA reserves the right to amend any part of the guidance document from time to time. CONTACT INFORMATION For further information, please contact: MEDICAL DEVICE AUTHORITY Ministry of Health Malaysia Level 5, Menara Prisma No. 26, Jalan Persiaran Perdana Precint 3, Putrajaya MALAYSIA Fax: (03) Website: iii

4 MEDICAL DEVICE CONFORMITY ASSESSMENT PROCEDURE BY WAY OF VERIFICATION PROCESS FOR MEDICAL DEVICES THAT HAVE BEEN APPROVED BY RECOGNISED FOREIGN REGULATORY AUTHORITIES OR NOTIFIED BODIES 1 Introduction Conformity assessment is a process of evaluation and evidence generated and procedures undertaken by the manufacturer, under the requirements established by the Medical Device Authority (MDA) to determine that a medical device is safe and performs as intended by the manufacturer. Manufacturer or authorized representative (AR) is required to collect evidence of conformity of its medical device and shall appoint a conformity assessment body (CAB) to asses conformity of the medical device to the requirements of Medical Device Act 2012 (Act 737) and its subsidiary legislations. Conformity assessment procedure for medical device that has been approved by foreign regulatory authority or notified body recognised by MDA may be done through a procedure called verification process. Verification process is a conformity assessment procedure by way of verifying the evidence of conformity of medical device that has been approved by foreign regulatory authority or notified body recognised by MDA. In verification process, the manufacturer or AR shall appoint a registered CAB to verify the evidence of conformity of the medical device. 2 Purpose This guidance document is intended to provide guidance to manufacturer, AR and CAB in Malaysia for conformity assessment procedure by way of verification process for the evidence of conformity of medical device that has been approved by foreign regulatory authority or notified body recognised by MDA. It identifies the requirements, eligibility of CAB to perform the verification process and the manner in which MDA approves the conformity assessment certificate and report issued by CAB after the verification process has been completed. It also provides the manufacturer, AR and CAB with the indicative man-hour for the process of verification provided by the manufacturer or AR of the medical device. 3 Scope and application This guidance document prescribes requirements for conformity assessment through verification process for medical devices that have been approved by regulatory authorities or notified bodies recognised by MDA. It is applicable to all medical devices except for those which are exempted from registration. 4 Term and definitions For the purposes of this document, the terms and definitions in ACT 737, the regulations under it apply. 1

5 5 Requirements for verification process 5.1 Recognised foreign regulatory authorities and notified bodies and the respective approval types a) Verification process is applicable to medical devices that have been approved by regulatory authorities or notified bodies recognised by MDA except for medical devices which are exempted from registration under section 5 of Act 737. Recognised regulatory authorities and notified bodies and the respective approval types which are eligible for verification process are shown in Table 1. Table 1: Recognised foreign regulatory authorities and notified bodies and the respective approval types eligible for conformity assessment by way of verification process Recognised foreign regulatory authority or notified body Therapeutic Goods Administration (TGA) Australia (ii) Health Canada, Canada (iii) Notified bodies listed in New Approach Notified and Designated Organisations (NANDO) database of European Union (EU) (iv) Ministry of Health, Labour and Welfare (MHLW) Japan (v) Food and Drug Administration (FDA), United States of America (USA) (vi) Other foreign regulatory authorities or notified bodies TGA licence Approval Type Health Canada medical device licence For general medical device: Annex II Section 3 or Annex V of MDD (for Class IIA) Annex II Section 3 or Annex III coupled with Annex V of MDD (for Class IIB) Annex II Section 3 and 4 of MDD (for Class III) Annex II Section 3 and 4 of AIMDD (for active implantable medical device) For IVD medical device: Annex IV (Including Section 4 and 6) of IVDD (for List A IVD) Annex IV (excluding Section 4 and 6) or Annex V coupled with Annex VII of IVDD (for List B and selftesting IVD) MHLW licence US FDA 510(k) clearance letter [510(k) exempted products do not qualify for abridged evaluation route]; or US FDA pre-market approval (PMA) letter To be determined by MDA from time to time b) Medical devices which have not obtained approval by regulatory authorities or notified bodies listed in Table 1 is required to undergo full conformity assessment by 2

6 any registered CAB in accordance with the requirements stipulated in Section 7(1)(a) of Act Eligibility and liability of CABs to conduct verification process a) Act 737 has delegated conformity assessment duties to CABs who are registered under Section 10 of Act 737. Hence, it is pertinent that the CABs to carry out the responsibility with due diligence without compromising on the various regulatory requirements as stipulated in the Act 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 Medical Device Regulations (MDR) b) The following criteria shall apply for the eligibility of CABs for performing conformity assessment of a medical device by way of verification process Where a medical device has its conformity assessment already done by a recognised foreign notified body, 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 done by any other CABs; (ii) For medical devices which have been subjected to conformity assessment by recognised foreign regulatory authorities, the verification process of the said medical device may be done by any CABs; (iii) Where a medical device has its conformity assessment already done by a recognised foreign notified body, and at the same time has been subjected to one or more conformity assessment by other recognised foreign regulatory authorities, then the criteria in sub clause shall similarly apply; (iv) Where a medical device has its conformity assessment already done by any other regulatory authorities recognised by MDA from time to time, then the criteria in shall apply; and (v) The CABs eligible to conduct verification process shall have been registered with at least one scope under Medical Device Technical Area and does not necessarily cover the Medical Device Technical Area being assessed. Example: A CAB with registered scope of MD 0203 may conduct verification process on a medical device under any Medical Device Technical Areas. 5.3 Conformity assessment elements and parameters to be verified by CAB a) The parameters to be verified by CAB in its verification process shall comprise of the conformity assessment elements as stipulated in Third Schedule of MDR2012 as follows Conformity assessment of quality management system (QMS); (ii) Conformity assessment of post market surveillance system (PMS); (iii) Conformity assessment of technical documentation; and (iv) Conformity assessment of declaration of conformity (DoC). b) The extent of verification activities will depend on the classification of the medical device. The conformity assessment elements and the parameters to be verified for each element are shown in Table 2. 3

Table 2: The conformity assessment elements and the parameters to be verified Conformity assessment element 1) Conformity assessment of QMS 2) Conformity assessment of PMS (for Class B, C and D) 3)

7 Table 2: The conformity assessment elements and the parameters to be verified Conformity assessment element 1) Conformity assessment of QMS 2) Conformity assessment of PMS (for Class B, C and D) 3) Conformity assessment of technical documentation 4) Declaration of conformity (DoC) Parameters to be verified Authenticity of the manufacturer s ISO certificate issued by foreign recognised notified body (listed in NANDO database) or regulatory authority granting the certificate or other equivalent QMS recognized by MDA; (ii) Scope of certification; and (iii) Validity of certificate. List of any ongoing PMS issue globally; (ii) List of incidents for the past 3 years (if applicable); and (iii) Date of last audit. Authenticity and validity of CE mark certificate and/or evidence of approval by recognised foreign regulatory authority; (ii) Adequacy of labelling of the medical device; (iii) Common Submission Dossier Template (CSDT). Adequacy of the declaration of conformity including supporting documents according to MDA/GD/ Verification Process 6.1 Verification steps for Class A (active, sterile or with measuring function) medical device 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 3 respectively. Figure A: Verification steps for Class A medical device 4

Table 3: Verification steps and parameters to be verified for Class A medical device Step Parameters to be verified 1) Medical device information Must be a medical device, based on intended use as

8 Table 3: Verification steps and parameters to be verified for Class A medical device Step Parameters to be verified 1) Medical device information Must be a medical device, based on intended use as described in technical documentation; (ii) Correct classification and application of risk classification rule. 2) QMS Authenticity of the manufacturer s ISO certificate issued by foreign recognised notified body or regulatory authority granting the certificate or other equivalent QMS recognised by MDA; 3) Technical documentation (ii) Scope of QMS of the manufacturer: either a full QMS or one without design and development control (the most suitable); (iii) All certificates submitted shall be within validity period. Claims on labels and labelling consistent with information on intended use provided in step 1; (ii) Aspects of manufacture concerned with: - securing and maintaining sterile conditions, eg sterilization report stating that packaging material and expiry date achievable with method of sterilization employed; - conformity with metrological requirements, eg calibration certificate; - conformity with active medical device requirements, eg IEC test report; (iii) Bahasa Malaysia requirement for non-professional use in labelling. 4) DoC DoC prepared according to MDA/GD/ Verification steps for a Class B, C or D medical device Verification steps and parameters to be verified by CAB for a Class B, C or D medical device are described in Figure B and Table 4 respectively. Figure B: Verification steps for a Class B, C or D medical device 5

9 Table 4: Verification steps and parameters to be verified for a Class B, C or D medical device Step Parameters to be verified 1) Medical device information Must be a medical device, based on intended use as described in technical documentation; (ii) Correct classification and application of risk classification rule. 2) QMS Authenticity of the manufacturer s ISO certificate issued by foreign recognised notified body or regulatory authority granting the certificate or other equivalent QMS recognized by MDA; (ii) Scope of QMS of the manufacturer of medical device: for Class B, either a full QMS or the one without design and development control (the most suitable); for Class C or D, full QMS; compliance with applicable standards (horizontal & vertical), eg IEC for active medical device; (iii) All certificates submitted shall be within validity period; (iv) Designation of notified body is still valid. 3) PMS Is there is any ongoing PMS issue globally? If yes, list the incidents; 4) Technical documentation (ii) List of incidents that have been resolved for the past 3 years (if applicable); (iii) Date of last audit. Authenticity and validity of CE mark certificate and/or evidence of approval by recognised foreign regulatory authority; (ii) CSDT; (iii) Adequacy of labelling of the medical device. 5) DoC Is DoC prepared according to MDA/GD/ Recommended man-hours and issuance of certificates by CAB The recommended man-hours for a CAB to perform the verification process, including report writing and issuance of certificates for all classes of medical devices is 2 hours per application. 7 Report and certificate Upon completion of the verification process, and if the CAB is satisfied that all the requirements have been fulfilled, CAB shall issue the report and certificate of conformity by way of verification to the manufacturer and AR of the medical device. 6

10 7.1 Report of conformity The report of conformity by way of verification shall contain the following: Details of CAB that include the name, address and registration number of the CAB and the name of the technical personnel conducting the verification process; (ii) Details of AR or manufacturer applying for verification process that include the name, address, establishment license number and contact number of the AR or manufacturer; (iii) Details of medical device that include name, classification and manufacturer of the medical device; (iv) Verification review result against Table 2; and (v) The report shall be signed by technical personnel of the CAB. (vi) The CAB may use report template as shown in Annex A. 7.2 Certificate of conformity a) The elements of certificate of conformity by way of verification shall be as per the template in Annex B. b) The certificate shall be valid for 5 years. 7

11 Annex A (Normative) Conformity Assessment Report Template CAB Letterhead Conformity Assessment Report (by way of verification on evidence of conformity) Details of CAB Name of CAB Address CAB Registration No. Details of establishment applying for verification process Manufacturer/AR Name: Manufacturer/AR adress: Establishment license No: Details of medical device Name of medical device Classification and classification rules Manufacturer of medical device Verification Review items Review result Remarks Evidence examined Result (comply/no) Conformity assessment of quality management system Authenticity of the manufacturer s ISO certificate issued by foreign recognised notified body or regulatory authority granting the certificate or other equivalent QMS recognised by the authority; (ii) Scope of certification; and (iii) Validity of certificate. Conformity assessment of post-market surveillance system 8

12 List of any ongoing post market surveillance (PMS) issue globally ; (ii) List of incidents for the past 3 years(if applicable); and (iii) Date of last audit Conformity assessment of technical documentation Authenticity and validity of CE mark certificate and/or evidence of approval by recognised foreign regulatory authority; and (ii) Adequacy of labelling of the medical device; and (iii) Common Submission Dossier Template (CSDT) Declaration of conformity(doc) Adequacy of the declaration of conformity including supporting documents according to MDA/GD/0025. Review Conclusion Conclusion and Recommendation Name and signature of technical personnel : Name and signature of certification manager : Date: 9

13 Annex B (Normative) Certificate of Conformity Template < CAB Name & Logo> Certificate of Conformity (by way of verification on evidence of conformity) This is to certify that : < Name of client> < Address of client> Holds certificate No: < Certificate No> Scope: On the basis of our verification on evidence of conformity of medical device approved by recognised foreign regulatory authorities and/or notified bodies for the medical device below. < list of medical device, class and manufacturer > For and on behalf of < Name of CAB> Signed by: <Certification Manager> Effective Date: Expiry Date: CAB Registration No: 9

14 MEDICAL DEVICE AUTHORITY MINISTRY OF HEALTH, MALAYSIA Contact Information: Medical Device Authority Ministry of Health Malaysia Level 5, Menara Prisma No. 26, Jalan Persiaran Perdana Precint 3, Putrajaya MALAYSIA T: (03) F: (03) Website:

Central Drugs Standard Control Organization

Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India Central Drugs Standard Control Organization (Medical Devices