What certification is required for medical device export to Russia
From：
Tech Company Date：02-15 284 Belong to：Industry Trends
With the advent of various diseases, many countries have strict control over imported medical devices, and the same is true of Russia. Mikhail Mishustin, President of the Russian Federation Government, signed Decree No. 299 on March 18, 2020, approving the list of medical devices that have established a national special registration procedure. Now let's take you to know!
Russian customers who often export should understand that Russian certification standards are generally more complex in Russian! The cycle process is also relatively complicated, and it must be more than a few months. Especially for the Russian National Medical Device Registration Certificate of medical products, the certification cycle is often more than a few months. This time, the Decree No. 299 will greatly reduce the certification cycle of some medical products to 2-3 weeks, helping relevant enterprises to quickly clear customs!
According to the Russian Federation Government's amendment No. 299 of March 18, 2020 on the framework registration specification of medical devices, the registration specification of medical devices is changed as follows:
1. Simplify the certification of 36 types of medical devices, so as to introduce medical device products into domestic circulation in Russia in a short time.
2. The certification process is simplified into two stages:
Stage 1: The applicant provides the following information, and the national department] reviews the relevant documents, and issues the medical registration certificate after the review, so that the product can enter the Russian market for circulation.
1. Certification application form
2. Necessary documents related to medical devices
3. Clear pictures of medical devices and necessary accessories
4. Other relevant necessary documents
Stage 2: - After the stage, the applicant shall submit samples for test within the review period and submit the following medical registration documents:
1. Medical device normative documents and experimental reports
2. Original medical registration certificate
3. Other relevant necessary documents
Russian customers who often export should understand that Russian certification standards are generally more complex in Russian! The cycle process is also relatively complicated, and it must be more than a few months. Especially for the Russian National Medical Device Registration Certificate of medical products, the certification cycle is often more than a few months. This time, the Decree No. 299 will greatly reduce the certification cycle of some medical products to 2-3 weeks, helping relevant enterprises to quickly clear customs!
According to the Russian Federation Government's amendment No. 299 of March 18, 2020 on the framework registration specification of medical devices, the registration specification of medical devices is changed as follows:
1. Simplify the certification of 36 types of medical devices, so as to introduce medical device products into domestic circulation in Russia in a short time.
2. The certification process is simplified into two stages:
Stage 1: The applicant provides the following information, and the national department] reviews the relevant documents, and issues the medical registration certificate after the review, so that the product can enter the Russian market for circulation.
1. Certification application form
2. Necessary documents related to medical devices
3. Clear pictures of medical devices and necessary accessories
4. Other relevant necessary documents
Stage 2: - After the stage, the applicant shall submit samples for test within the review period and submit the following medical registration documents:
1. Medical device normative documents and experimental reports
2. Original medical registration certificate
3. Other relevant necessary documents
