HKSTP organized a seminar named “Medical
Device Regulatory Affairs and Quality Assurance” on 25 April 2016. This seminar is set to tackle the
increasingly complicated International, Asian and European medical device
regulations and quality requirements. The
seminar aims to share knowledge on medical devices regulations in major
jurisdictions such as US, Europe, ASEAN and Hong Kong, as well as how to
maintain and apply them and avoid the pitfalls form both practical and academic
perspectives. I took a photo with Prof. Albert
Poon at the end of seminar for memory.
Prof. Albert Poon (Professor of
Practice (Biomedical Engineering), Interdisciplinary Division of Biomedical
Engineering, Faculty of Engineering, PolyU; Associate Specialist, Medical
Device Program of SGS Academy) was the first speaker and his topic entitled “Medical
Device Regulation and Life Cycle Management”.
Prof. Poon said the figures in the left hand side of the first slide
demonstrated today’s topics included Regulations (FDA, CE), Hong Kong Medical
Device Regulation Choice and Design Control which followed US or EU in R&D
area.
Firstly, Prof. Poon mentioned the
Ideal Healthcare System included Safe, Effective, Patient Centered, Timely, Efficient
and Equitable. He added the most
important was the intended purpose of MD.
Then he introduced the MD Life Cycle as follows.
1.
Innovation, R&D
2.
Product Realization, Commercialization
3.
Proof of Quality, Effectiveness and Safety
4.
Clinical Trials, Evaluation and Product Performance
5.
Product Safety and Risk Classification
6.
Quality and Risk Management
7.
Industry Self-Discipline (In HK, 手中無劍, 心中有劍.)
8.
Regulation
9.
Management
Prof. Poon described the Health
Technology Management included R&D, Regulations, Assessment and
Management. He explained Health
Technology Assessment (HTA) is the systematic evaluation of properties,
effects, and/or impacts of health technology.
The following diagram showed the
Health Technology tree which classified different types of health
technology. Then Prof. Poon told us the
important ingredients for a successful implementation of HTA at the country levels,
which were good governance, funding, adequate staffing and good collaboration
with partners.
Product life span of a medical
device was discussed which included Manufacturer, Vendor and User.
Aspects of MD Life Cycle
Management are shown as following diagram. Where
HTA = Health Technology
Assessment
HTR = Health Technology Regulation
HTM = Health Technology Management
QMS = Quality Management System;
RM = Risk Management
After that Prof. Poon explained
two types for MD regulation which one followed US FDA and the other followed EU
CE Mark. EU CE Mark is based on system
approach. Prof. Poon then briefed the Medical
Device registration in USA (21 CFR 800-1299) and EU system (AIMD, MDD &
IVDD). Finally, he briefed the
harmonization of regulation of MD and IVD.
Lastly, Prof. Poon introduced
types of medical equipment (see diagram) and 10 categories which defined by HA
below.
1.
Chemistry analyzers and laboratory equipment
2.
Gas incubator and safety cabinet
3.
Cardiac diagnostic and monitoring equipment
4.
Eye, ear, nose and throat equipment
5.
Non-cardiac diagnostic, monitoring and surgical equipment
6.
Infusion pump
7.
Ventilator
8.
Physiotherapy equipment
9.
Renal equipment
10.
Miscellaneous (e.g. nebulizers, scalers)
Mr. Kelvin Sze (Certification
Officer, SGS Hong Kong) was the second speaker and his topic named “ISO 13485
Quality Management System Introduction”.
He told us three elements regulatory bodies were most concerned that
were Safety, Effectiveness and Quality Assurance.
Firstly, Mr. Sze compared
different regulation of Medical Device included USA, China, EU and Hong Kong
Proposed Framework. Hong Kong’s one is
only human and based on Global Harmonization Task Force (GHTF) and ISO 13485.
Then Mr. Sze compared ISO 9001
and ISO 13485. It observed that ISO
13485 required consistently to meet customer requirements, in which customer
included the regulatory bodies.
Moreover, customer satisfaction and continual improvement were
de-emphasized. ISO 13485 is not focus on
continual improvement but emphasized to maintain the effectiveness of the
QMS.
After that Mr. Sze summarized the
change in the new standard ISO 13485:2016 below:
New requirements (where risk management
is in all clauses)
- Cl. 4.2.3 Medical Device File
- Cl. 6.2 Human resources
- Cl. 6.4 Work environment and Contamination control
- Cl. 7.3.8 Design and development transfer
- Cl. 7.3.9 Control of design and development change
- Cl. 7.3.10 Design and development files
- Cl. 7.5.7 Particular requirements for validation of processes for
sterilization and sterile barrier systems
- Cl. 8.2.2 Complaint handling
- Cl. 8.2.3 Reporting to regulatory authorities
- Cl. 8.3.2 Actions in response to nonconforming product detected before
delivery
- Cl. 8.3.3 Actions in response to nonconforming product detected after
delivery
Finally, Mr. Sze briefed the EU
regulation Update and some main topics were shown in the following
diagram.
Lastly, Mr. Sze introduced SGS
professional certificate in Medical Device RA/QA programme to us.
During Q&A, I asked a
question if Cl. 7.3.10 Design and development files equivalence to FDA Design
History File (DHF). Mr. Sze said the
requirements were similar but the format was different which case was same as
EU Technical File. He also mentioned the
old standard ISO 13485:2003 will update to ISO 13485:2016. Until now, EN ISO 13485:2012 (included Annex
2A, 2B & 2C) was employed in Europe. (In EU, regulatory bodies only
concerned EN ISO 13485:2012 which had harmonized.)
Reference:
HKSTP - http://www.hkstp.org
20091124: ISO 14971 Risk
Management for Medical Device Manufacturer Seminar - http://qualityalchemist.blogspot.hk/2009/11/iso-14971-risk-management-for-medical.html
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