China continues its massive update of Medtech standards
China is continuing its efforts to modernise the national technical standards infrastructure. Back in 2015, CFDA announced a plan to bring forward a complete update of technical standards, with the ambitious goal of writing or revising 500 technical standards in 5 years. In 2016 CFDA announced the development of 186 new Industry Standards (“YY Standards”) including 42 mandatory (YY) and 144 voluntary (YY/T) standards.
The standards program continues apace and last month, on May 17, CFDA announced their specific work program for the next year, which included 69 new and 31 revised standards. The scope of the list is wide-ranging, covering IVD instruments, specific test methods for biocompatibility, and product and test standards for a wide range of devices including dental, orthopaedic, ophthalmic and electromedical. Many are clearly based on existing IEC or ISO norms (e.g. the range of IEC 60601-2- series standards such as those for transport incubators, medical beds and MRI equipment.
The reform program is also addressing the mismatch between China standards and international ISO and IEC documents, where China hasn’t kept up with the latest revisions in many areas – leading to frustrating requirements to bring forward test data against standards which are superseded internationally. The “standards program aims to bring all of the China standards in line with their international equivalents, as well as adding a whole range of unique product and testing standards. A good example is IEC 60601-1-2 General requirements for basic safety and basic performance. Collateral standard: Electromagnetic disturbance requirements and tests which is included in this latest batch of revisions.
Some notable inclusions are in advanced technology areas including the voluntary (YY/T) standards :
- Medical Ti-6Al-4V Powder for Additive Manufacturing
- High-throughput gene sequencers
- Medical electrical equipment classification, terminology and definitions using robotics
This program is part of China’s increasing involvement in international technical standardisation. China has taken a leading role at IMDRF in the strengthening of harmonised approaches to use of standards
But at a practical level, for manufacturers entering China, knowledge of the national industrial standards is essential. The Chinese regulatory system includes a Type testing phase where the device must be tested against the requirements of applicable standards. Many of the standards are “YY/T” “voluntary” standards. But, as they say in China, nothing is as it seems. Voluntary standards are still considered a default best practice by reviewers and departures need to be carefully justified at the initial testing stage.
Considering entry into the China market? Our bilingual experts can support your China compliance needs. We support strategy, Type Testing, Clinical Evaluation, CFDA submissions, postmarket compliance and reimbursement. We are experienced at the preparation of technical reports including biocompatibility and Clinical Evaluation reports to support CFDA filings. Also – check out our latest training video on some of the radical changes to China regulations planned for introduction in 2018.