EU and China pledge dialogue on regulatory policy
This article was originally published in Clinica
The environment is beginning to look increasingly promising for better trade in medical devices and diagnostics between the EU and China.
The European Commission has opened a new dialogue with the Chinese authorities, which is aimed at achieving closer regulatory understanding and convergence, with the visit of Erkki Liikanen, European Commission Director General for Enterprise and the Information Society to the Chinese administration (AQSIQ), on June 22 in Beijing.
This is particularly good news for the EU medical devices and diagnostics industries, as the markets of the Far East are widely assumed to be the fastest growing in the world. And regulatory barriers have been among the most frustrating aspects of exporting to these countries (apart from the tariff barriers to trade, which are now progressively lowering).
This is a new step in a negotiation process that has already begun; a dialogue on industrial policy is already set up. And in the medical devices sector, discussions have already been initiated between the European Commission and the Chinese State Drug Administration, particularly on the Chinese requirement to type test all class II and III medical devices imported into the country (see Clinica No 1068, p 2).
The latest dialogue between the Commissioner and AQSIQ should help support a gradual softening of the Chinese approach towards the type testing of medical devices as well as closer collaboration on other aspects of medical device regulations, including closer co-operation on standardisation and conformity assessment bodies and even on test results.
The Commissioner proposed on June 22 that the EU-China Dialogue on Regulatory Policy could address issues including the challenges faced by regulators in managing new technologies or products that are on the cutting edge, and the cost impact on manufacturers of regulations, that may affect their ability to compete, innovate or create jobs.
Within the context of this dialogue, the European Commissioner believes that action should be taken to deepen the knowledge of each party's regulatory environments and practices. The Commissioner is promoting improving regulatory transparency on both sides in a systematic way, giving priority to dialogues on newly introduced regulation and policy, and co-operating better on standards and conformity assessment issues.
"We should undertake to ensure that our domestic technical regulations, standards and conformity assessment procedures do not become an unnecessary obstacle to investment and trade," Mr Liikanen told the AQSIQ. This, he proposed, could be achieved by the two parties by them:
* advancing their co-operation on international harmonisation of technical regulations, standards and conformity assessment procedures and promoting the equivalence of technical regulations and standards;
* promoting the acceptance of test results and related data wherever possible to reduce costs for business and facilitate market access; and
* involving standardisation and conformity assessment bodies in dialogue, emphasising the need to identify areas of specific common interest to produce practical results.