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Events and Symposia

2nd PMDA Medical Devices Training Seminar(DAY 3)

Topic 1: Case study

Day 3 sessions began with the case study on the review of generic medical devices presented by Dr. Toshiko Oka and Dr. Takeshi Shiba of Office of Medical Devices III. The participants were divided into two groups and deliberated on the considerations to be given in the review of microcatheter, PTA balloon catheter and ophthalmic laser photocoagulator, as sample cases, from the viewpoint of substantial equivalence. Both groups showed diligent and excellent thinking through good discussions

Case studyCase study

 

Topic 2: Today's lecture

Today's lectures

The first lecture in the afternoon was given by Ms. Seiko Oyama from BSI Japan K.K. on the medical device certification by registered certification bodies under the PMD Act, which took effect on November 25 last year, focusing on the impact of the new act on third party certification. This lecture was specially arranged because the scope of third party certification shall be expanded under the new act, and the importance of effective and reliable certification has become ever greater.

The last lecture of the day was on quality management for medical devices and the actuality of QMS inspection presented by Mr. Katsuya Sawadaishi of Office of Manufacturing/Quality and Compliance. As the requirements for quality management have also been revised under the PMD Act, there is a considerable impact on QMS inspection as described in this lecture. This lecture also provided good background knowledge for the visit to the manufacturing site scheduled on the next day, although the visit is not intended for inspection.

Today's lectureToday's lecture

 

Comments from participant

Mr. Alvin Bay, Ms. Wei Xuan Tee, Ms. Amritamayee Sahoo and Ms. Melody Tay, HSA, Singapore There was a great sharing and brainstorming session in the morning and we have a better understanding of how PMDA assess and review generic medical devices.
It is interesting to learn about the third party registered certification body system of review in Japan, as it is different from what we have in Singapore. The lecture also covered QMS inspection process clearly with comprehensive flow charts and diagrams.
 

(from left to right)
Mr. Alvin Bay, Ms. Wei Xuan Tee, Ms. Amritamayee Sahoo and Ms. Melody Tay, HSA, Singapore

 

 

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