Template of Declaration of Conformity - Health Sciences 的符合性声明模板健康科学

1、Form no. DOC-v1/11DECLARATION OF CONFORMITYTo be printed on Company Letterhead of Product OwnerName 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 Perfo

2、rmance as laid out in the Health Products (Medical Devices) Regulations.Medical Device(s): Manufacturing Site: Risk Classification: e.g. Class B, rule 6 / Class A, rule 1Quality Management System Certificate:For Class B, Class C and Class D medical devices, declaration of conformity to either of the

3、 following QMS standards is mandatory:-ISO 13485US FDA Quality System RegulationsJapan MHLW Ordinance 169For Class A medical devices that are not manufactured under either of the abovementioned QMS standards, certification obtained for alternative QMS standards (e.g. ISO 9001) shall be listed in thi

4、s section, if applicable.For Class A medical devices that do not hold the following QMS certifications:-ISO 13485US FDA Quality System RegulationsJapan MHLW Ordinance 169 an attestation that a quality management system has been established shall be submitted in place of supporting documents required

5、 for the abovementioned QMS standards. The attestation shall be made by the Product Owner. The template for the attestation (Form No. QMS-A-V1/11) has been provided below.Standards Applied: This declaration of conformity is valid from Authorised Signatory:_ _Name, Position DateForm no. QMS-A-v1/11QU

6、ALITY MANAGEMENT SYSTEMS ATTESTATION TEMPLATETo be printed on Company Letterhead of Product OwnerMedical Device BranchHealth Products Regulation GroupHealth Sciences AuthorityDateDear Sir/Madam,Subject: Quality Management Systems AttestationWe attest that the manufacturer(s) of the medical devices l

7、isted below has/have established and is/are maintaining, with proper and adequate documentation, a Quality Management System (QMS) to ensure that the medical devices consistently meet the requirements for safety, quality and efficacy in the design, development, production and distribution of these m

8、edical devices. The quality manual(s) for the QMS is/are maintained by the manufacturer(s) and we will obtain copies of such manual(s) for the Authority on request by the Authority.We understand that this attestation will expire three (3) years from the above-stated date. We will submit a new attestation to the Authority upon the expiry of this attestation or earlier in the event that the validity or accuracy of this attestation is affected or altered in any way.Medical Device(s): List containing product names of