On May 19 2017 the State Council promulgated amendments to the Regulation on the Supervision and Administration of Medical Devices 2014, which took effect immediately. The amendments clarify issues relating to:
- device distributors' liabilities when selling non-conforming products;
- the use of large medical equipment; and
- the revocation of clinical study site certification.
The key changes introduced by the amendments can be summarised as follows.
Exemption from penalties for device distributors selling non-conforming products
Under the original Article 66 of the Regulation on the Supervision and Administration of Medical Devices, device distributors were penalised by the relevant local counterpart of the China Food and Drug Administration (CFDA) if they sold devices that did not meet the mandatory standards or technical requirements. In practice, it is unreasonable to require a distributor to conduct quality inspections on incoming devices to ensure compliance with this article. As such, the amendments have clarified that device distributors can be exempted from penalties if they fulfil the inspection obligations under the regulations and can identify the source of such devices.
Device study sites need not be pre-certified
Medical institutions can conduct clinical studies if they complete record filing with the local authorities. The criteria will be promulgated and announced by the CFDA and the National Health and Family Planning Commission.
Authorities can supervise deployment of large medical equipment
According to the amendments, 'large medical equipment' is defined as any large medical equipment that:
- involves complicated technology;
- requires major investment;
- has high operating costs; and
- will have a significant impact on medical costs.
Large medical equipment is subject to catalogue management. The amendments specify that local health authorities can penalise hospitals that fail to comply with the restrictions for using large medical equipment, such as excessive examination and excessive treatment. Under the previous administrative rules that governed large medical equipment, health authorities were authorised only to issue an order to cease the use of the relevant equipment if a hospital violated the restrictions for large medical equipment use. However, the amendments provide that local health authorities can impose a fine of between five to ten times the amount of the illegal proceeds for any use of large medical equipment without a permit. In addition, providing false materials when applying for a large medical equipment permit will be subject to a fine of no more than Rmb100,000.
For further information on this topic please contact Katherine Wang at Ropes & Gray LLP by telephone (+86 21 6157 5200) or email (email@example.com). The Ropes & Gray LLP website can be accessed at www.ropesgray.com.
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