Import Permit for Registration Samples in Russia Under Ministry of Health Order No. 661n

1. Key takeaways

To import unregistered medical device samples for the purpose of state registration, an import permit is required under Order No. 661n of the Ministry of Health, dated 30 June 2020. The permit is single-use, valid for 1 year, and the approval step at the Ministry of Health takes about 5 working days. Without this permit, test samples cannot legally enter Russia, and neither technical testing nor clinical trials can start. The permit is therefore the true opening move of the Russian registration timetable: every downstream milestone, from bench testing to clinical evaluation, depends on samples being in the country and in the laboratory on schedule.

Because the permit is single-use and batch-specific, the logistics plan and the test plan must be settled before the application is filed. Quantities, models and batch identification stated in the permit must match the physical shipment, and any change to the test program after the permit has been issued may require a fresh application rather than an amendment. Teams that treat the permit as an administrative formality and file it late often lose weeks at the start of the project, which no later stage can recover. The permit also anchors the customs description of the goods: laboratories, brokers and the manufacturer all work from the same figures, so any drift between them is visible to the reviewer and to the border authorities.

2. Legal basis

The sample import permit operates alongside the general registration rules and the federal prohibition on circulating unregistered devices, with its own dedicated pathway. The table below lists the instruments relied on in this article, with reference numbers, dates and relevant provisions.

3. Expert insights

Insight one: the sample permit is a one-year, single-use authorization. It is issued for specific batches and quantities; it is not a pass valid for the whole registration period. If the test program extends beyond one year, a new permit is required. Projects should therefore be planned so that testing, sample consumption and the permit window align, and so that a second application can be prepared without panic if the program overruns. Shipping margin quantities within the permitted figures is a standard way to avoid a second import cycle.

Insight two: the sample permit and the general import of unregistered devices are not the same pathway. The reason the registration sample permit is granted smoothly is that the application states the registration purpose explicitly. If goods are actually intended for exhibition display or for clinical use outside the registration program, the appropriate import pathway must be selected according to that actual purpose. Using a registration sample permit as cover for other purposes exposes the shipment to challenge at customs and undermines the whole filing. Each import should be mapped to the pathway that matches its true purpose before shipment is booked.

Insight three: from 1 September 2026 the general import rules have been renewed. Government Resolution No. 557 replaces the previous rules and remains in force until 1 September 2032. Although the sample permit follows its own dedicated pathway under Order No. 661n, the practical execution of both regimes needs to be checked together, since the same shipments may involve documents, declarations and customs procedures touched by both frameworks. A compliance calendar that tracks only one of the two rules leaves blind spots in the import file.

Insight four: the 5-working-day approval is short but unforgiving. The approval window is brief, yet an application with inconsistent model names or quantities will be corrected rather than approved, and each correction restarts the clock. A pre-filing review of the permit application against the final shipping documents is the cheapest insurance available in this process.

4. Practical recommendations

The steps below keep the sample import track aligned with the testing timetable. They apply to any project that requires unregistered samples in Russian laboratories under the registration program.

1. Start the permit application as soon as the test plan is settled, and build the 5 working days approval time into the project schedule.
2. Keep the device names, models and quantities in the permit strictly identical to the physical shipment; any inconsistency invites customs questioning.
3. After testing, retain records of sample disposition (retention, destruction or return) for later traceability.
4. Where the test program may exceed one year, prepare the follow-up permit application before the first permit expires.
5. Appoint one owner for the sample file, covering the permit, the customs documents and the disposition records, so the trail stays complete through the registration cycle.

5. Verification checklist

Confirm each item below before and after the sample shipment. The checklist covers the permit content, its validity and the parallel import frameworks.

• □ The import permit for registration samples has been obtained under Order No. 661n
• □ The names, models and quantities stated in the permit match the physical goods
• □ The permit validity (1 year) covers the whole test program
• □ Other import pathways that may apply under Government Resolution No. 557 have been checked
• □ Sample disposition records have been archived

Regulatory information verified as of 29 October 2026.

GRZAN manages the import of registration samples for the Russian market: preparing and filing Order No. 661n permit applications, aligning permit content with shipping documents, coordinating customs clearance and maintaining the sample disposition archive for traceability. For support with a sample import program, contact GRZAN at info@grzanglobal.com.