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. Regulation9. 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 ManagementQMS = 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
8. Physiotherapy equipment
9. Renal equipment10. 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.)
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