The past year has seen a flurry of activity around China’s medical device regulations and much of the reforms have been focused on encouraging innovation while at the same time beefing up post-market enforcement. But for the reforms to be successful, the regulators should consult more with industry, according to attorneys at Ropes & Gray.
China’s National Medical Products Administration (NMPA) should take a step-wise approach by first exempting innovative or life-saving devices with urgent clinical needs from confirming to mandatory standards, the attorneys suggest.
China has 454 mandatory standards and many of them are not harmonized with ISO or IEC standards, they note in a white paper, adding that rigid conformance with the mandatory standards “may force a device manufacturer to change its product design specifically for the Chinese market.”
Time to Market
Such design changes may not enhance product safety and effectiveness and could delay time to market and hinder access for patients, the attorneys said.
The law firm urged the regulatory authority to “regularly solicit and listen to the industry’s concerns on mandatory standards.” When a Chinese standard is inconsistent with the latest international standard, devicemakers should be able use the latest international standard, the law firm suggested.
When several manufacturers fail to comply with mandatory standards, the regulator should have discussions with the manufacturers to determine if the relevant standard is hindering technology development, it said.
Study authors Katherine Wang, a partner in Ropes & Gray’s Shanghai practice, and Tina Wu, a senior associate in the Shanghai office, said they hoped to see the NMPA adopt a risk-based approach to review product technical requirements for all devices, “rather than mechanically applying mandatory standards to all devices.”
Although the regulator has released a number of policies to improve clinical evaluation, the law firm said more guidance is needed as there are limited opportunities for pre-submission consultations (IDDM, Sept. 3).
User-friendly Approach Needed
Many devicemakers have been unable to take advantage of the lowered bar for clinical evaluation, the attorneys said. One of the barriers is establishing substantial equivalence in a manner acceptable to the Center for Medical Device Evaluation, the paper says, urging the regulator to adopt real-life examples and/or concrete assessment criteria. CMDE should regularly publish representative cases and explain how examiners drew their conclusions, the attorneys suggested.
The authority could rely on foreign real-world evidence when devices have been marketed in other countries for years but lack adequate premarket clinical data. It has made some pilot moves in this direction, but clear guidance on accepting real-world evidence is needed and is in line with global regulatory trends, the paper says (IDDM, April 9).
Positive outcomes have been achieved in the pharma industry by adding reviewers and expanding pre-submission communication with industry and the regulator, and the attorneys urged the CMDE to take similar steps in the medical device space.
Finally, the NMPA should adopt a more current approach to its device classification system. After discussions with stakeholders about IVD classifications, the regulator learned that many cases of noncompliance were due to conservative product classification. The attorneys urged the regulator to take a similar approach for medical devices and build on these types of successes.
Read the white paper here: bit.ly/2NPLOHy.