1. INTRODUCTION
1. INTRODUCTION
1.1. Purpose
1.1. Purpose This document provides guidance to assist a product owner in the preparation of a Declaration of Conformity (DOC) to Singapore’s regulatory requirements.
1.2. Background
1.2. Background One element of a global regulatory model for medical devices is that the product owner attests that its medical device complies fully with all applicable Essential Principles for Safety and Performance and draws up a written DOC.
1.3. Scope
1.3. Scope This document is applicable to all medical devices that are to be supplied in Singapore.
1.4. Definition
1.4. Definition Nil. MEDICAL DEVICE GUIDANCE NOVEMBER 2022 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 5 of 8
2. COMPONENTS OF A DECLARATION OF CONFORMITY
2. COMPONENTS OF A DECLARATION OF CONFORMITY The DOC (see Annex 1) shall be in English and should contain the following information:- • an attestation that each medical device that is subject to the declaration complies with the applicable Essential Principles for Safety and Performance, and has been classified according to the device classification rules; • information sufficient to identify the device/s to which the DOC applies; • the risk class allocated to the device/s after following the guidance found in Principles of Medical Device Classification; • the date from which the DOC is valid; • the name and address of the product owner; • quality management standards; • medical device standards (product standards 1 ); • the name, position and signature of the responsible person who has been authorised to complete the DOC upon the product owner’s behalf. R1.3 ► The Essential Principles for Safety and Performance of medical devices is applicable for all medical devices, is in accordance with the Health Products (Medical Devices) Regulations 2010 and laid out in GN-16 Guidance on Essential Principles for Safety and Performance of Medical Devices. ◄ 1 Standards may include international (e.g. ISO, IEC), regional (e.g. CEN) and national (e.g. SS, ASTM, BS) standards. MEDICAL DEVICE GUIDANCE NOVEMBER 2022 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 6 of 8
3. WHO IS RESPONSIBLE FOR PREPARING THE DECLARATION OF
3. WHO IS RESPONSIBLE FOR PREPARING THE DECLARATION OF CONFORMITY The product owner of the medical device or a person authorised by the product owner is responsible for preparing and signing the DOC. The hardcopy of the DOC should be signed and dated. The signed and dated hardcopy should be scanned for submission as part of product registration. The original signed copy of the DOC should be made available to the Authority upon request. MEDICAL DEVICE GUIDANCE NOVEMBER 2022 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 7 of 8
Annex 1 — Annex 1
ANNEX 1 DECLARATION OF CONFORMITY [To be printed on Company Letterhead of Product Owner] Name and Address of Product Owner: We hereby declare that the below mentioned devices have been classified according to the classification rules and conform to the Essential Principles for Safety and Performance as laid out in the Health Products (Medical Devices) Regulations. Manufacturing Site: R1.1 ►< Physical manufacturing site(s) including sterilisation site(s) > ◄ Medical Device(s): < e.g. product name and model number> Risk Classification: e.g. Class B, rule R1.1 ►< Risk Classification of medical device(s) according to the classification rule, and the rule(s) used to determine the classification> ◄ Quality Management System Certificate: < Certification Body and Certificate Number, issue date, expiry date> For Class B, Class C and Class D medical devices, declaration of conformity to either of the following QMS standards is mandatory: • ISO 13485 • US FDA Quality System Regulations • Japan MHLW Ordinance 169 Standards Applied: < International standards; OR Regional Standard; OR See Attached Schedule for multiple standards > MEDICAL DEVICE GUIDANCE NOVEMBER 2022 HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 8 of 8 This declaration of conformity is valid from <Day Month Year> Authorised Signatory: ___________________________ _____________________ Name, Position Date Contact Information: Medical Devices Cluster Health Products Regulation Group Health Sciences Authority 11 Biopolis Way, #11-03 Helios Singapore 138667 www.hsa.gov.sg