China, Medical Devices, New Regulation

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The original promulgation of MDR in China was issued on 2000. Since this year the CFDA – China Federal Drug Administration has issued numerous proposed rules and guidance documents.

On March 31, 2014, CFDA released proposed implementing regulations on registration, manufacturing, distribution, and use of medical devices for public comment.

Now, the Revised MDR was approved and has taken effect in June 1, 2014.

What are the most important news?

1) the medical device definition

The definition from the 2000 MDR was based on the “purpose” for which the instrument, apparatus, appliance, material or other article was to be used.

The Revised MDR’s definition still centers on the “purpose” of the device, but also

adds “life support or sustenance” as an intended purpose for a medical device.
add in vitro diagnostic reagents and calibration products as types of medical devices.

2) The Medical Device Classification

The device classification provisions in the Revised MDR retain the three-class categorization system.

The Revised MDR, however, is more specific about how classification works,

To defining the classification , CFDA will consider a device’s intended purpose, structural characteristics, method of use, and other relevant factors.

The Revised MDR also clarifies the procedure for classifying a new type of device

3) Device Registration

The Revised MDR eliminates the pre-marketing registration requirement for Class I devices.

Now

Class I devices need only undergo a “filing” procedure with a municipal regulator (i.e., below the provincial level).
Class II and Class III devices must still be registered through a licensing procedure.

Import manufacturers may follow the general registration and filing procedures applicable to domestic devices, with certain exceptions. For example, applicants must file (for Class I devices) or register (for Class II or III devices) with CFDA, instead of with provincial or municipal regulators.

Therefore interesting news was introduced about registration amendament

Currently, amendments are required for any changes in model, specifications, location of the manufacturing facility, product standards, product performance, structure and composition, and scope of use.

Now an amendment to a registration need only be submitted during the device license term if a change occurs that affects the safety and efficacy of the device.

4) Clinical trial

The Revised MDR clarifies that Class II and Class II devices may be exempt from the clinical trial requirement under the following three circumstances, which CFDA will determine:

devices for which there exists an already-marketed equivalent in terms of manufacturing, design, and operating mechanism, with a good safety record;
devices for which safety and effectiveness may be proven using non-clinical data; and
devices for which clinical trial data already exists.

5)Manufacturing

The Revised MDR explicitly permits contract manufacturing of most medical devices except for high- risk implantable devices.

CFDA will publish a catalogue of devices that may not be manufactured according to a contract manufacturing arrangement.

6)distribution

The notification and licensure requirements for entities distributing Class I and II devices will be more simple.

Specially:

Distributors of Class I devices will no longer have a filing requirement.
Distributors of Class II devices have to go through a less cumbersome “filing” procedure with the municipal level food and drug regulatory authority.
Distributors of Class III devices must still obtain a distribution license.

7)Labelling

The Revised MDR specifies that the product insert and label must include, among other things:

the common name, model and specifications;
name, address and contact information of the manufacturer;
date of manufacture and expiration date;
product performance, composition and scope of use;
contraindications and other alerts; and
special storage instructions.

For imported medical devices, the product insert and label must be in Chinese.

8) Use of medical device by public and private institution

Medical institutions must record identifying information relating to Class III devices to ensure traceability in the case of adverse events.

In this case, it will be expected to stop the use of the device, and notify the manufacturer or other institution responsible for the quality control of the device.

9)Adverse Event Monitoring, Device Re-evaluation, and Recalls

The Revised MDR introduces strictly rules regarding adverse event monitoring, device reevaluation (AE Measures) and recalls (Recall Measures).

the Revised MDR explicitly requires that:

medical device manufacturers, distributors and medical institution users monitor for and report adverse events
the National Center for ADR Monitoring and CFDA improve their monitoring and review of adverse events,
the CFDA reevaluate a medical device that has caused serious injury or death.
if the mandatory standard not be respected, the manufacturers should stop production, notify distributors, medical institution users and other consumers, recall the products and report the recall to CFDA and the National Health and Family Planning Commission.

10) enforcement

The Revised MDR significantly increases penalties for prohibited acts, specially in case of manufacturing or distributing without a license.

The last topic

On April 11, 2014, CFDA issued a notice on the implementation of the Revised MDR: in this that calls for provincial authorities to amend or cancel any of their rules that are not in conformity with the Revised MDR.

Therefore it would be important to monitor the cancellation of the old rules by the provincial food and drug regulatory authorities

China - The revised Medical Device Regulation has taken effect on June 1st, 2014