Currently the National Medical Products Administration (NMPA) only accepts the GB 9706.1:2007 which is identical to IEC 60601-1:1988+A1:1991+A2:1995, despite the new version being published in 2005. In this article we look at the reasons for this delay in implementation.
China has one of the largest medical product markets in the world. Due to the size of the market, however, the latest version of the standard does not fit well with the large volumes involved. This has created disagreements over the implementation of a new standard.
When standards such as ISO and IEC are converted into Chinese standards, they ordinarily receive a prefix of GB (national standard) or YY (specific industry standard) – YY is for medicine industry including medical devices. For example, the IEC 60601-1-2 becomes YY 0505 and the second edition of IEC 60601-1 is identical to Chinese standard GB 9706.1:2007. The decision to title a standard with the prefix GB or YY depends on a wide variety of factors, including the submitted date for approval, the importance of the standard (mandatory or recommended), and other regulatory consideration.
Why Has IEC 60601-1, 3.1. Edition Been Delayed?
Medical standards are different in China to those in other countries. In other countries/regions, they provide a manufacturer in regulatory with a fundamental criterion on how to design a medical product to meet minimum requirements before it is placed on the market. The manufacturer then has the decision about whether to just meet the standard or exceed it. If they also have the capability to perform adequate testing to ensure the product meets the standard, there is no requirement for independent third-party testing before the product is placed on the market.
GB and YY standards are endowed with the regulatory requirements that all manufacturers must obey. The standards must be applied throughout the entire process – design, manufacturing, operation, usage and surveillance. The only way to validate whether a medical product fulfills the requirements is to let NMPA test centers perform the type test before issuing a report that denotes it has passed and is an officially accepted product. In some ways, Chinese standards are endowed with more regulatory power than those in other countries.
In reality, this system works simply for standards that refer only to test items but the difficulty with IEC 60601-1, 3.1 edition is it includes clauses that do not relate to testing. For example, clause 14 relates to software evaluation – previously IEC 60601-1-4 – and the evaluation of risk management files. This is administratively out of the scope of NMPA test centers according to regulations for the supervision and management of medical devices in China.
This difference between Chinese and International standards has contributed greatly to the delay in adopting the IEC 60601-1, 3.1 edition.
Transforming IEC 60601-1, 3.1 Edition into GB 9706.1:20xx
The Standardization Administration of the People's Republic of China (SAC) created a special team to take lead in evaluating the possibility of converting 3.1 edition into a Chinese standard when the standard was accepted around the world. Subsequent research showed that superseding the current GB 9706.1:2007 would be beneficial to China, however unexpected events have greatly delayed this process.
In 2014, Technical Committee 10 (same role as SC62A of TC62 in IEC) operated by the CMTC Shanghai under SAC took the lead to begin transforming IEC 60601-1, 3.1 edition. It was decided to skip edition 3.0 and immediately begin with 3.1. The project used different organizations and test centers for the purposes of translation and validation, which took over one year to finish.
The exposure draft then received hundreds of comments. In December 2015, all committee members, experts and manufacturer representatives met to validate the translated standard. At a closed meeting in Nanjing, Jiangsu Province, eight special teams were arranged to thoroughly verify the content of the translated version. It was accepted and became a standard draft for approval.
Soon after this, at the IEC TC62 annual meeting in Kobe, it was announced there would be some technical revisions to the existing 3.1 edition and subsequently a 3.2 edition will possibly be published in 2019 depending on the urgency of some technical comments received. Considering the uncertainty of the coming changes, the Chinese project leaders then postponed the publication of the approved draft standard in order to ascertain what the difference would be as the transformation project is difficult and time consuming.
In October 2016, TC62/SC62 received more than 300 comments about the existing 3.1 edition, among all, 78 suggestions were selected and deemed as urgent technical changes that would be taken into the consideration for further development for 3.2 edition. This survey reinforced the decision to postpone the publication of GB 9706.1:20xx.
Furthermore, the cancelation of the IEC/TC62 2017 annual meeting then meant the proposed publication of 3.2 edition at the beginning of 2019 was delayed. The project team for GB9706.1:20xx continues to consider 3.1 edition to be unstable and therefore the draft version for approval of GB9706.1:20xx was suspended once again.
What Happens Next?
In recent months, senior administrators have voiced the opinion that Chinese standardization should keep pace with international standards. This would mean the restart of adopting IEC 60601-1, 3.1 edition.
While the transformation of 3.1 edition has been troubled, the transformation of other particular standards, for example the IEC 60601-2-xx series, has continued. There will come a time when the translated parts are ready for approval and external pressures may speed up the transformation. When this happens, there will be a new study of the updates in 3.2 edition and a draft version will be created using aspects of 3.1 and 3.2, thereby minimizing future changes.
Finally, it is clear from official sources that movement towards the adoption of an updated IEC 60601-1 is happening. One officer has even reported at an annual summit that GB 9706.1:20xx will be published in 2019. This information did not, however, come with a specified date.
For more information, please contact:Gavin-Y Yin | 尹勇
Laboratory Manager, Medical Electrical Devices Lab
t: +86 21 6191 5607