QT ANALYSIS: Quality Management System Requirements for Foreign Manufacturers

QT ANALYSIS: Quality Management System Requirements for Foreign Manufacturers – December 2022/January 2023

2022-12-27

Medical Device QMS is a structured plan of action covering all features of design, manufacturing flow, supply chain, risk management, customer service, troubleshooting, clinical analysis, storage, distribution, and labelling. A well implemented QMS will assist the company in lowering costs, improving performance, reducing waste, and providing a structured training baseline for new and current employees.

Standards like ISO 9001 and ISO 13485 are well acknowledged QMS guidelines for a company that is partially or fully involved in the medical device business. And in most cases foreign manufacturers are recognized by having a QMS certificate of compliance with these standards, issued either by their local government or an accredited certification body.

This certificate gives a lot of beneficial representation such as attesting to the status of the company or manufacturer regarding the competence and reliability of the personnel and facilities. Moreover, this certificate is one of the key regulatory requirements on registering a product such as Medical Devices not only locally but also globally.

Hence, in the following we are discussing the QMS requirements for foreign medical device manufacturers in different countries.

QMS Requirements for Foreign Medical Device Manufacturers in the ASEAN Countries

Most of the ASEAN countries who founded their medical device regulation on the recommendations of the International Medical Device Regulatory Forum (IMDRF) based their QMS compliance for foreign manufacturers with the ISO 13485.

The ISO 13485:2016 standard is divided into eight sections, the first three of which are the scope, normative references, and terms/definitions. While the succeeding sections are the specific QMS requirements. The following information are the key requirements for foreign manufacturers on demonstrating the implementation of QMS on their company with respect to ISO 13485.

KEY REQUIREMENTS OF ISO 13485

Company Overview

Process Design

(Quality Manual)

Product Documentation

(Medical Device File)

Internal Audit

(Control of Documents and Records)

(1) A documented statement of a quality policy and quality objectives covering:

(a) Management Responsibilities

(b) Human Resources

(2) Documents and records to ensure the effective planning, operation, and control of the company processes.

(3) Other applicable regulatory documentations

The company should have a quality manual that includes the following:

(a) Scope of the QMS, details and justification of any exclusion.

(b) Documented procedures of QMS and its interaction between processes

The content of the file(s) should have the following, but is not limited to:

(a) General description of the medical device, intended use/purpose, and labelling, including instructions for use

(b) Product specification

(d) Procedures for measuring and monitoring

(e) Procedures for installation and servicing (if applicable)

A well written procedure or protocol to control the documents and records of the company for:

(a) Review and approve documents/records for adequacy prior to issue

(b) Ensure that the current revision status of and changes to documents/records are identified and remain legible and readily identifiable

(d) Prevent the unintended use of obsolete documents/records

The company must ensure that any changes to the available documents/records are reviewed and approved either by the head of approving committee or another designated member of the company that has access to the documented information.

The following are the ASEAN countries that made ISO 13485 certification a mandatory requirement for foreign manufacturers for the means to demonstrate conformity of medical device QMS and have included some country-specific requirements.

Country	Additional Country-Specific Requirements / Reference Regulation
Indonesia	The document needed to be submitted to ID MoH is the certificate of compliance with ISO 13485 • In Indonesia, the name of the manufacturer + address shall be consistent with Certificate of Free Sale (one of the requirements for Indonesia registration • For Class A medical devices, a valid ISO 9001 issued by an accredited certification body is still recognized and acceptable.
Thailand	Scenario 1: In case the product is a medical device in the origin country, the accepted QMS are ISO 13485 or GMP in medical device. Scenario 2: In case the product is not a medical device in the origin country, for Class A, the accepted QMS is ISO 9001. • In Thailand, the QMS certificate can be submitted as a soft copy. • The QMS certificate shall be valid and has a related scope to the registered product.
Vietnam	Vietnam requires an ISO-13485-compliant QMS for foreign medical device manufacturers as per the Government promulgated Decree prescribing medical device management. No.: 98/2021/ND-CP
Malaysia	Malaysia requires an ISO-13485-compliant QMS for foreign medical device manufacturers according to the Medical Device Act 2012, The Medical Device (Duties and Obligations of Establishments) Regulations 2019 and Act 737
Philippines	The Philippines requires an ISO-13485-compliant QMS for foreign medical device manufacturers as stated in the legal requirements under Administrative Order (A.O) No. 2018-002. In case the manufacturer is unable to provide the ISO 13485 certificate, GMP certificate is acceptable if it complies with any foreign standard that may be recognized by the Philippine Department of Health (DOH)
Singapore	Singapore acknowledged ISO 13485 Certificate issued by EU NB / Conformity to US FDA Quality System Regulation or Japan MHLW Ordinance 169. For Class A Medical Devices Dealers a Declaration of Conformity (DoC) to QMS is acceptable. The DoC shall be in English and should contain the following information: (a) 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. (b) information sufficient to identify the device/s to which the DOC applies. (c) the risk class allocated to the device/s after following the guidance found in Principles of Medical Device Classification. (d) the date from which the DOC is valid. (e) the name and address of the product owner. (f) quality management standards. (g) medical device standards (product standards). (h) the name, position and signature of the responsible person who has been authorized to complete the DOC upon the product owner’s behalf.

QMS Requirements for Foreign Manufacturers in Other Countries that Adopted ISO 13485: 2016

In addition to ASEAN, several other nations have embraced ISO 13485 on developing their own national QMS regulations including their country-specific requirements for businesses engaged in the medical device industry.

Countries	Country-Specific Requirements / Reference Regulation
Hong Kong	All the requirements will follow ISO 13485 or YY/T 0287 requirements. However, in HK, the name of the manufacturer + address shall be consistent with those stipulated in the marketing approval certificate(s) of GHTF countries (IVD and general medical devices) + China NMPA (only allowed for general medical devices) • The document needed to be submitted to HK MDD is only an ISO 13485 or YY/T 0287 depending on the medical devices to be registered (IVD or general medical devices)
Japan	In order to bring the standards for medical device QMS into compliance with the worldwide standard ISO13485:2003, MHLW MO169 was first formed in 2004. The ordinance has undergone numerous revisions since it was first established. • Class 1 medical devices are exempted from the requirements of design and development. • The retention period of obsolete documents required by the ordinance • Clinical evaluations and/or evaluation of performance of the medical devices are required to be implemented as part of design and development validation, in the case that the medical device is designated by 23-2-5.3 or 23-2-9.4 of PMD Act
Australia	Australia formally recognizes ISO 13485, as a standard for medical device manufacturers quality management system. Including the following adoption. • A scheduled program of the management review in accordance with ISO 13485:2016-Clauses 5.6 should be demonstrated by the manufacturer. • The purchasing requirements should be described and fulfilled for suppliers identified by the manufacturer in accordance with ISO 13485:2016-Clause 7.4.1, 7.4.2 and 7.4.3 • The manufacturer must maintain the supporting procedures and records of supplier evaluations which are made by the manufacturer or recognized third party. This also includes any agreement between the manufacturer and supplier with pre-defined responsibilities and authorities. • For QMS Quality Manual procedures should be demonstrated ISO 13485-Clause 4.2.2 • For Medical Device Documentation: (1) Validation processes for production and service provision (ISO 13485- Clause 7.5.6) (2) Post-market monitoring system (ISO 13485- Clause 8.2.1) (3) Advisory notices and the notification (ISO 13485-Clauses 7.2.3 and 8.5.1) • For Internal Documentation Audit, A scheduled program of the internal in accordance with ISO 13485:2016-Clauses 8.2.4 should be demonstrated by the manufacturer. Further QMS related and applicable certificates/conformity are also acceptable as long as they adhere to foreign standards and are approved by regulatory body that TGA recognizes such as the following: Certificate of compliance that follows EU MDR (Annex IX QMS), QMS Certificate from Japan Ministry of Health, Labor and Welfare (MHLW) MSAP Certificate from Health Canada (MDR SOR/98-282M) MSAP Certificate from US FDA Premarket Approval (PMA) Current registration as a Class B, C and D medical device with Singapore HSA
EU Region	Compliance with EN ISO 13485:2016 provides presumption of conformity with the basic QMS requirements for CE marking under the Annex IX Chapter 1 of the Regulation (EU) 2017/745. Upon compliance the manufacturer needs to make sure that the following documentation are well prepared for the QMS Assessment as described below. QMS Assessment Requirements: • Application for Assessment i. Manufacturer Information ii. Device information iii. QMS Documentation (procedures, descriptions, and obligation) iv. Documentation on PMS, Clinical Evaluation • Implementation of QMS i. Manufacturer's quality objectives. ii. Company structure (roles, methods of operation, 3^rd party verification) iii. Procedures and techniques for monitoring, verifying, and validating the design of the devices and corresponding documentation. iv. Verification and quality assurance techniques at the manufacturing stage including sterilization, appropriate test, and trials. • Audit Notified bodies shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer in question applies the approved QMS and PMS plan. • Surveillance assessment applicable to class IIa, class IIb and class III devices: The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations arising from the approved quality management system
USA	The US Food & Drug Administration (FDA) has issued a proposed rule to harmonize US Quality System Regulations (21CFR820) with ISO 13485 and to make Certificate of compliance with ISO 13485 mandatory. The content of the quality management system documentation shall be the following 21 CFR 820: • Management Responsibility • Quality Audit and Personnel • The date the facility site(s) will be ready for inspection • Outline the structure of the quality manual or quality system documentation • Quality policy and objectives • Organizational structure and responsibilities or authority • References to basic quality system procedures The manufacturer shall establish a medical device file for each type or series of medical devices as evidence that their manufacturer complies with the provisions of the Act and these Regulations: • Establishment registration • Medical Device Listing • FDA approval/clearance (or IDE) • Quality System Regulation Labeling Requirements • Medical Device Reporting (MDR) The manufacturer shall control the documents used for the quality management system. • Corrective and Preventive Action • Complaint Handling • Production and Process Controls (including Purchasing Controls) • Process Validation • Equipment and Facility Controls • Document, Records & Change Controls. • Warning Letter Data and Resources Key differences between 21 CFR 820 and ISO 13485: • Documentation requirements: 21 CFR 820 is higher • Customer satisfaction and continuous improvement: ISO 13485 is higher • Complaint and reporting system
Taiwan	Taiwan established their QMS requirements in accordance with ISO 13485 standards as well. All the QMS key requirements mentioned above also apply to the Taiwan QMS regulations. • In addition, the following documents are also required. • 1. Manufacturing flowchart • 2. Plant layout diagram • 3. Production area information • 4. Major manufacturing equipment and inspection instruments.
China	China acknowledges ISO 13485 certification to meet the most recent standards for quality management systems, including the evolving regulatory standards and technological demands. A recognized third-party entity must conduct an audit in order to get this certification. The key requirements that are sought after by auditors include the following • Proof or evidence of quality assurance procedures • Systems for managing and reducing risk • Product traceability for those utilized in manufacturing • Documentation that the quality system is self-maintained and measure to promote internal improvement Moreover, for those companies or organizations that engage in medical device production activities within the territory of the People's Republic of China, a local Chinese GMP is required following the recent published regulation "Promulgated by Order No. 53 of the State Administration for Market Regulation” on March 10, 2022, including the following key topics • QMS principles • Organization and personnel • Plan, facilities, and equipment • Document and record control • Development and Design • Purchasing • Production • Quality Control • Contract manufacturing • Authenticity and traceability of product