I want to comment on Grace's post as I'm in contact with SGS in China on a regular basis about this topic. I'm on ETF-3 of the CB scheme so I'm connected with the IEC test labs which is not the regulator side of testing but they are connected to them in some countries and my connection in China does have that type of connection. So, this is what I have found out.
It is correct that
NMPA issued GB 9706.1-2020 (equivalent to IEC 60601-1 edition 3.1 was issued on April 9, 2020, and there is a 3 year transition period. The normal expected position is "there is a 3 years transition period time before its official implementation in May 2023. Before GB 9706.1-2020 comes into effect in 2023, NMPA only accept test reports based on IEC 60601-1 edition 2 to determine whether certain testing items performed overseas can be exempted from repeating a complete IEC 60601-1 edition 2 based on GB 9706.1-2007."
Now for what I have found out recently:
- "Because the GB 9706.1-2020 (EQV to 3.1 edition) is still a new standard for NMPA. The old acceptance criterion (GB 9706.1-2007) is still effective until there comes up with new ones.
- From the testing capability perspective, most of NMPA registered labs have not yet got this new standard accredited, therefore, if there was a new report tested according to new version of GB 9706.1-2020, it may encounter with a rejection letter during the registration process.
However, I confirmed this issue with the leader of technical committee of medical devices, he told me that, currently, it's risky to submit the new reports directly till some labs obtain the accreditation in future, he and other officers are under plan to propose a suggestion to NMPA centre office that trying to accept both editions after the middle of transition period, say, in 2022 or later on, in order to let the submitters and also the NMPA staffs get used to the new reports in advance. If the proposal is accepted, there will be a guidance published accordingly for proper handling on the NMPA registration."
This information is not set in stone but is advance information but being on standards committees does have it's advantages......
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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email:
Leo@EisnerSafety.comWebsite:
www.EisnerSafety.com------------------------------
Original Message:
Sent: 09-Oct-2020 14:01
From: Grace Fu Palma
Subject: IEC 60601 VS. China GB 9706.1 for Medical Electrical Equipment Testing
We were asked regularly about whether China NMPA will accept IEC 60601-1 edition 3.1. Here is the latest update.
Test reports based on IEC 60601-1 3 edition cannot be accepted by NMPA at this time. NMPA currently still requires electrical medical devices to comply with "GB 9706.1-2007", which is a mandatory national standard converted from "IEC 60601-1 edition 2". Even though on April 9, 2020, NMPA issued GB 9706.1-2020 (equivalent to IEC 60601-1 edition 3.1 ), there is a three year transition time before its official implementation in May 2023. Before GB 9706.1-2020 comes into effect in 2023, NMPA only accept test reports based on IEC 60601-1 edition 2 to determine whether certain testing items performed overseas can be exempted from repeating a complete IEC 60601-1 edition 2 based on GB 9706.1-2007.
Just a note that GB is an abbreviation of "Guobiao" which means 'National Standards' in Chinese. NMPA has been publishing GB standards that are adopted directly from international standards sometimes with certain modifications to suite China market needs. However, they could be in a different revision than the most current international editions or include some Chinese-specific requirements. During registrations, medical devices are required to demonstrate its full compliance with all applicable GB and YY standards.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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