1. Registration in Russia

In order to sell the cardiographs on the territory of Russia it is necessary to receive the following permission documents:

• 1. Registration Certificate (RC) from Roszdravnadzor (Federal Service on Surveillance in Healthcare and Social Development).
• 2. Declaration of Conformity (DC) from an accredited body.
• 3. Approval Certificate of Measuring Instruments (MI) from the Federal Agency for Technical Regulation and Metrology.

The validity of RC is unlimited, DC – 1-3 years, MI – 5 years. These documents may be issued both on a manufacturer and a distributor availability of a Power of Attirney from a manufacturer. The receiving of these documents will require 8-14 months and US$12-20 thousand.

The sequence of receiving these documents is as follows: RC-DC-MI. The most difficult is to receive the RC.

The steps to get the RC are the following:

• Technical testing
• Test on electromagnetic compatibility
• Clinical trials in two medical institutions
• Toxicology test
• Expertise of the documents
• Consideration of the documents in Roszdravnadzor.

The site of Roszdravnadzor (www.roszdravnadzor.ru) has a list of the authorized organizations in which it is possible to conduct the stated tests of cardiographs and the expertise of the documents as well as the list of documents to be submitted to receive the RC. Roszdravnadzor registers 3-5 thousand medical devices within a year about half of which are of Russian origin. About 30% of refusals occur in registration during the “first approach”.

2. Registration in China

In order to enter the Chinese market of electrocardiographs it is necessary to receive the following documents:

• Registration Certificate (RC) from the provincial administration of the Food and Drug Administration (FDA);
• CCC Certificate (China Compulsory Certificate or 3C) from the China Quality Certificate Center.
The supervision and the administration of the medical equipment in China are fulfilled by the following institutions:
• State Food and Drugs Administration (SFDA);
• Ministry of Health;
• State General Administration of Quality Supervision< Inspection and Quarantine (AQSIQ).

The office of SFDA which reminds the American FDA was established in 2003 and is subject to the State Council of China. In 2000 SFDA developed the Regulations for the Supervision and Administration of Medical Devices. It is necessary to pass the clinical tests in two medical institutions during the registration process. The office of AQSIQ inspects the certification process and sets the technical standards. 3C Certificate (ChinaCompulsoryCertificate) is required only for the seven types of medical devices whose use is associated with the risk to the health of patients, including the electrocardiographs – both the foreign and the Chinese. The marking of 3C is done by the Quality Certification Administration (CNCA).

The process of receiving 3C certificate is the following:

• 1. Submission of the application with the test reports.
• 2. Testing of the samples of the type of cardiographs in the test laboratory.
• 3. Inspection of cardiographs production in the country of origin at the expense of the applicant.
• 4. Evaluation of the results of the certification tests.
• 5. Subsequent inspection of the plant for the cardiographs production.

In China, unlike in Russia, RC and 3C certificate are issued to the manufacturer. In order to sell the imported cardiographs it is necessary to register in the central SFDA as well as to appoint a representative and a service agent in China who will coordinate and supervise the registration process.

When registering of a foreign cardiograph in China, the obtaining of RC will require 1-2 years and US$6500, and the obtaining of 3C – 1 year and US$3000 for one model. The validity period of RC is 4 years. In China, the local FDAs have their own rules of registration and certification which go beyond the state regulations.

The sites of the mentioned above state bodies are as follows:

• http://www.sfda.gov.cn
• http://www.moh.gov.cn
• http://www.aqsiq.gov.cn