Medical Regulatory Affairs

An International Handbook for Medical Devices and Healthcare Products

Jack Wong, Raymond Tong, Jack Wong, Raymond K. Y. Tong, Raymond Tong, Jack Wong, Raymond K. Y. Tong

• Publisher: Jenny Stanford Publishing
• Year: 2022
• Print ISBN: 9789814877862
• eBook ISBN: 9781000440539
• Edition: 3
• Topic: Medicine
• Subtopic: Biotechnology in Medicine

This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.

Chapter 1 How to Train University Students in Regulatory Affairs to Face the Medical Devices Market Growth after the COVID-19 Impact

Raymond K. Y. Tong

Department of Biomedical Engineering, The Chinese University of Hong Kong, Shatin, Hong Kong

[email protected]

This chapter focuses on how to design a regulatory course to train university students in regulatory affairs.

1.1 Introduction

Medical device regulation comes with new framework, new principal and supportive responsibilities in Asian and European countries. The COVID-19 pandemic has created the largest disruption of healthcare and education systems in history. The demand of medical devices for vaccination, diagnosis, treatment and telehealth purposes has surged. The Medical Devices Market Size was valued at US$ 483,285.8 million in 2019 and is projected to reach US$ 767,684.9 million by 2027 [1]. The compound annual growth rate (CAGR) is estimated to be 6.1% from 2020 to 2027. Asian markets have significant growth. The market in China reached US$ 78.81 billion in 2018, at a rate of 22% from 2017. The Indian medical device market reached US$ 6 billion in 2017 and is projected to reach US$ 50 billion by 2025 [1]. The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for European Medicines Agency and for national competent authorities in the assessment of certain categories of products. The course should be suitable for students who are studying biomedical engineering, biomedical science, healthcare, or medical device engineering. These students should have some experience in a health- or engineering-related field and should wish to start working in the growing field of regulatory affairs. The course in regulatory affairs aims to give both factual and practical knowledge of what is regulatory requirement and how to handle future regulatory tasks. On completion of the course, students will be able to demonstrate their understanding of how to meet the standards and regulatory requirements, and they will be able to handle regulatory tasks, including classification, risk management, ISO standard, product registration, and commercial materials review.

Students will be trained to understand the global, regional, and local medical device regulatory requirements and trends. Besides conducting lectures, students will be arranged into a small group to work on a medical device and practice preparing a medical device registration submission to a competent authority. The competent authority is a body that has authority to act on behalf of the government to ensure that the requirements of the medical device directives are transposed into the national law and are applied. Guest lecturers with regulatory experience and network will be invited to share their experience. Students who finish the course will be eligible for attending related medical device regulatory examination conducted by external bodies, such as notified bodies and the Asia Regulatory Professional Association.

1.2 A Sample of Regulatory Affairs Exercises for Students

1.2.1 Background

Consider this case. You have just been recruited by a manufacturing company, Poly Technologies Corporation (PTC), as project manager under its newly found business section for medical and healthcare products. The company has little, if any, experience in designing and manufacturing medical devices. Your primary duty is to provide internal consultancy to the top management of the company on new business development analysis and management of medical device design and manufacturing projects.

Last month your company’s top management signed a business agreement to collaborate with an overseas client, which is a global distributor of medical products. Under this collaboration agreement, your client and PTC will co-develop a series of medical devices for global markets. Your client has proposed to start a project with the sterile disposable hypodermic syringes with needles — for single-dose hypodermic injection (Fig. 1.1).

To begin with, your client has suggested designing and manufacturing the products for the US and EU markets and, if possible, extend the market to China in future.

Figure 1.1 Various sizes of hypodermic syringes.

Task 1 Classification

Your first task is to brief your management about the product classifications of the device. For more details, see Chapter 14, “Medical Device Classification Guide.”

Task 2 Risk Analysis

(For more details, see Chapter 16 on ISO14971.)

Target Device market classification	What are the US FDA regulation numbers	Classification rules applied to the product under EU medical device directive	Notified body involvement for CE marking?
EU
US
China

During the design phase of the device, suggest hazards for the product that the product design team has to include in the design input considerations.

Suggest the severity and occurrence for the suggested hazards. Ensure that you have provided your own table and definition of different levels of severity and occurrence.

Task 3 Risk Evaluation and Risk Control

(For more details, see Chapter 16 on IS014971.) You have to develop a risk graph (group for risk regions and decide the risk acceptability) and risk matrix (put all the above risks in your device).

Implement risk control measures for all of your hazards. After all risk control measures have been implemented and verified, the manufacturer shall decide whether the overall residual risk posed by the medical device is acceptable using the criteria defined in the risk management plan.

Task 4 Medical Device Registration Submission

Prepare a medical device registration submission to your competent authority.

For example, the student will represent the company to be the local responsible person in Hong Kong to submit an application for listing this product to the Medical Device Division (MDD), Department of Health in Hong Kong. The student will download the appropriate application form from the MDD website http://www.mdco.gov.hk/english/download/download.html and fill in the application form according to the information in the registration dossier provided. They will refer to the Overview of the Medical Device Administrative Control System (GN-01) and all guidance documents can be found at http://www.mdco.gov.hk/english/mdacs/mdacs_gn/mdacs_gn.html.

A mock up label will be required to show the Special Listing Information and provide the Essential Principles Declaration of Conformity in the submission. The sample of Essential Principles Declaration of Conformity is given in the Guidance Notes for Listing Class II/III/IV Medical Devices (GN-02) under the above-mentioned MDCO website.

1.2.2 Lifelong Learning

The above exercise is to equip students with lifelong learning skills to handle regulatory affairs and the requirements from the competent authority. Students should be encouraged to attend workshops/seminars which are organized by the competent authority, and key global (Asia-Pacific Economic Cooperation [APEC], Regulatory Affairs Professionals Society [RAPS]) and regional (Asian Harmonization Working Party [AHWP], Association of Southeast Asian Nations [ASEAN]) organizations.

References

1. Medical devices market growth sturdy at 6.1% CAGR to outstrip $767,684.9 million by 2027 — COVID-19 impact and global analysis, The Insight Partners, https://www.globenewswire.com/en/news-release/2021/04/26/2217087/0/en/Medical-Devices-Market-Growth-Sturdy-at-6-1-CAGR-to-Outstrip-767-684-9-Million-by-2027-COVID-19-Impact-and-Global-Analysis-by-TheInsightPartners-com. html.
2. ISO 13485 (Medical devices — Quality management systems — Requirements for regulatory purposes).
3. ISO 14971 (Medical devices — Application of risk management to medical devices).
4. Medical Device Division (MDD), https://www.mdd.gov.hk/en/home/index.html.
5. Medical Device Control Office (MDCO), http://www.mdco.gov.hk/eindex.html.
6. Asian Harmonization Working Party (AHWP) http://www.ahwp.info/.
7. International Medical Device Regulators Forum (IMDRF), http://www.imdrf.org/.
8. Asia Regulatory Professional Association (ARPA) https://www.linkedin.com/groups/3009071/.
9. International Organization...

Table of contents

• Cover Page
• Half Title Page
• Title Page
• Copyright Page
• Table of Contents
• Preface
• 1. How to Train University Students in Regulatory Affairs to Face the Medical Devices Market Growth after the COVID-19 Impact
• Part 1: Introduction
• Part 2: Medical Device Safety and Related Iso Standards
• Part 3: Medical Device Regulatory System in The United States, European Union, Saudi Arabia, and Latin America
• Part 4: Medical Device Regulatory System in Asia-Pacific Region
• Part 5: Hot Topics
• Index