Dealing with Regulatory Bodies It is important to keep in mind that each Asian country will have

Dealing with Regulatory Bodies

It is important to keep in mind that each Asian country will have their own specific requirements and procedures when dealing with regulatory agencies and governments in Asia. Local Asian offices of Western medical device companies should be involved in face-to-face meetings with local regulatory agencies and keep headquarters regularly updated with exactly what is happening. In almost all situations, in countries such as China, Japan and Korea, documents will need to be in the native language.

While the practice of lobbying is common in the West, it is less acceptable in some Asian countries. Western executives may be surprised that simply showing up at an Asian government regulatory office for a key meeting generally will not help your cause and actually may hurt you.When communication is necessary, let your company’s local Asian staff or local Asian distributor’s regulatory staff deal with the local regulatory body directly.

In some countries, disclosing all information and setting up pre-consultations before a product registration is customary. The Japanese Ministry of Health, Labor and Welfare expects medical device company executives to wear formal dark suits with a white shirt and a dark tie for meetings. In other Asian countries (especially in Southeast Asia), meetings with the government regulatory entity may be more casual, and no tie or jacket may be needed. Having personnel who are knowledgeable about such details is crucial.