CFDA Exempted 140 Class II Devices from Clinical Trial

China Food and Drug Administration (CFDA) issued notice exempting 140 Class II medical devices from submitting clinical trial when device producers apply for market entry from CFDA. This is already the second batch of clinical trial exemption.

For a Class II device maker outside China, perhaps JV with a local Chinese producer is one the best options if one looks for a long term reward in the Chinese market, depending on the nature of the product itself.

EU Commission proposed new rules on in-vitro diagnostic medical devices

The current EU regulatory framework for in vitro diagnostic medical devices ('IVDs') consists of Directive 98/79/EC of the European Parliament and of the Council ('the IVD Directive') IVDs cover a wide range of products that can be used for population screening and disease prevention, diagnosis, monitoring of prescribed treatments and assessment of medical interventions. The existing regulatory framework for in vitro diagnostic medical devices has demonstrated its merits but has also come under criticism in recent years.

This proposal is adopted alongside a proposal for a Regulation on medical devices that are currently covered by the AIMDD and the MDD. While the specific features of IVDs and of the IVD sector require the adoption of a specific legislation distinct from the legislation on other medical devices, the horizontal aspects common to both sectors have been aligned.

The Commission proposes important changes regarding various aspects relevant for the life-cycle of medical devices, such as the scope of the legislation, the pre-market assessment of devices, their control once on the market, the transparency of data concerning marketed devices and the management of the regulatory system by the authorities. The main changes in detail are:
• Wider and clearer scope of EU legislation, extended to include, for example, implants for aesthetic purposes, and clarified as regards genetic tests;
• Stronger supervision of independent conformity assessment bodies (so called 'notified bodies') by national authorities;
• More powers for notified bodies vis-à-vis the manufacturers, to ensure thorough testing and regular checks, including unannounced factory inspections at manufacturing sites;
• Clearer rights and responsibilities for manufacturers, authorized representatives, importers and distributors, including in the case of diagnostic services and internet sales;
• Extended database on medical devices (Eudamed), providing comprehensive and public information on products available on the EU market;
• Better traceability of devices throughout the supply chain, enabling a swift and effective response to safety concerns (e.g. recalls);
• Reinforced rules for clinical investigations on devices and the required clinical data for the pre-market and the continuous post-market assessment of medical devices, including in vitro diagnostic medical devices.
• Adaptation of the general health and safety requirements, including labelling provisions, to the technological and scientific progress.
• Introduction of classification rules that divide the broad range of in vitro diagnostic medical devices into four different risk classes as it already exists for other medical devices.
• Creation of a Medical Device Coordination Group composed of members representing national competent authorities in the field of medical devices to ensure better coordination between Member States, with the Commission providing the necessary scientific, technical and logistic support.

Medical devices and in vitro diagnostic medical devices produced in a third country and imported into the EU are subject to the same rules as medical devices produced within the EU.

Council Directive 90/385/EEC on Active Implantable Medical Devices

Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices could be downloaded here for reference.

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Waste Electrical and Electronic Equipment Directive (WEEE) Affects Medical Devices

In the new Directive 2012/19/EU on waste electrical and electronic equipment approved on 04 July 2012, medical devices are involved in the recovery and recycling scheme as well, whilst the recovery and recycling target tightens in the Directive. Active implantable & infective devices are still excluded.

Time line and recovery/recycling target are summarized as below.

Minimum targets applicable by category from 13 August 2012 until 14 August 2015 with reference to the categories listed in Annex I:

for WEEE falling within category 8 (medical device) of Annex I,

- 70 % shall be recovered, and

- 50 % shall be recycled;

Minimum targets applicable by category from 15 August 2015 until 14 August 2018 with reference to the categories listed in Annex I:

for WEEE falling within category 8 (medical device) of Annex I,

- 75 % shall be recovered, and

- 55 % shall be prepared for re-use and recycled;

Minimum targets applicable by category from 15 August 2018 with reference to the categories listed in Annex III:

for WEEE falling within category 4 (large medical equipment) of Annex III,

- 85 % shall be recovered, and

- 80 % shall be prepared for re-use and recycled;

for WEEE falling within category 5 (small medical equipment) of Annex III,

- 75 % shall be recovered, and

- 55 % shall be prepared for re-use and recycled

EU medical device manufacturers have to implement the Directive, non-EU medical device manufacturers also have to apply through their Authorized Representatives or Distributors, if they tend to market the devices in EU.

EU Commission Regulation on Electronic IFU of Medical Devices

EU Commission issued Regulation on Electronic IFU of Medical Devices (Nr. 207/2012) on 09 March 2012, a guidance cross-reference to directives AIMD 90/385/EEC and MDD 93/42/EEC.

A copy of the regulation can be downloaded here.

How to register medical devices to China SFDA

After a medical device manufacturer finds a distributor in China market, the manufacturer must register the product to SFDA so that the product can enter Chinese market legally.

The manufacturer shall authorize a registration agent in China to handle all the registration processes, and nominate after-sales service party before hand. The after sales service agent can be the same as the authorized distributor (please go to our featured article 'How to find distributors in China'), or can be a third party. The manufacturer shall also issue 'Letter of Guarantee to Authenticity' to guarantee the authenticity of the documents provided to SFDA through the registration agent.

Then the manufacturer and the registration agent can work on legal documents requested by SFDA.

The application form should also be filled in and submitted together with the requested documents.

The whole registration process may cost some time, which may also involve establishment of standards and testing depending on the classification of the devices to be registered.

Invitro Diagnostic Devices Directive - IVDD 98/79/EC

IVDD 98/79/EC is the directive that regulates in-vitro diagnostic medical devices in the European market.

Please download a copy here for reference.

IVDD 98/79/EC

The Bible in EU - Medical Device Directive

The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993) is intended to harmonise the laws relating to medical devices within the European Union. In conformity with MDD 93/42/EEC enables a manufacturer to legally place a medical device on the European market. Medical devices conforming with MDD 93/42/EEC must have a CE mark applied. The Directive was most recently reviewed and amended by MDD 2007/47/EC and a number of changes were made, which compliance was implemented on March 21, 2010.

A copy of MDD 93/42/EEC can be download here for reference.

(Click to download)