When should you start on the documents?

At the development stage. The requirements of the regulation affect the design, the materials and the marking, and changing them after production has started costs the most.

Are technical specifications needed?

Technical specifications are not mandatory if the product is made to a standard. But with your own formulation or design, technical specifications make it easier to prove conformity.

What if the tests are not passed?

The laboratory issues a test report with a negative result. The product is reworked and the tests are repeated; the document is not issued until the result is positive.

Launching a new product: where to start conformity assessment

A typical mistake of manufacturers is to start on the documents when the batch has already been produced. By this time the design and the packaging are approved, and every requirement of the regulation turns into rework.

Action plan

From idea to release

01Analysis of requirementsWhich regulations apply to the planned product

02DocumentationA standard or technical specifications, the passport and the operating manual

03SamplesMaking and selecting samples for tests

04TestsTest reports of an accredited laboratory

05Document and markingRegistration and application of the EAC mark

The first step costs less than all the others, but it decides what they cost.

What to prepare in advance

A description of the product. Purpose, conditions of use, materials, composition and design features.
A normative document. An interstate or national standard to which the product is made, or your own technical specifications.
Operating documents. The passport, the manual and the instruction; the regulation defines what they contain.
Data on the manufacturer. Full details and addresses of the production sites; they go into the document.

About the marking The EAC mark is applied only after the document of conformity is issued. Applying the mark without a basis is a separate violation and not “getting ahead of schedule”.

How much time to allow

An approximate schedule for a new item

Analysis of regulations

1–2 days

Preparation of documentation

1–3 weeks

Tests of samples

1–3 weeks

Issue of the document

2–5 days

For products with higher requirements (children’s goods, protective equipment, pressure equipment) the terms are longer.

Frequent miscalculations

How it happens

The regulations are read after the design is approved
The samples are not taken from a serial batch
The packaging is printed before the document is issued
People try to extend one document to the whole range

A more reliable way

The requirements are put into the technical specification
The samples are selected by the rules of the scheme
The packaging layout is agreed after the document is received
People check whether the document covers each modification

When the set of documents is clear, what remains is to choose the scheme. It decides whether inspection control and analysis of production are needed. This is covered in a separate article. To check the laboratory you have chosen, see the analysis of the Rosaccreditation register.

What the launch time consists of

A typical project for a new item takes eight weeks

Documentation 35% Tests 40% Issue 15% Marking 10%

People usually shorten the first part, and it is exactly this part that comes back later as rework after the tests.

Own production or a contract

This is a fork that decides the whole further route of the documents. It is chosen on the basis of economics, but the consequences are regulatory.

	Own production	Contract production
Who is the manufacturer	You	The factory or you, depending on the contract
Who is the applicant	You	Must be recorded in advance
Analysis of production during certification	Your site is inspected	The factory’s site is inspected
Change of site	Your decision	Can happen without your knowledge
Access to the formulation	Full	Agreed in the contract

The main point is the second from the end. The factory moved production to another site, the range is the same, but the manufacturer in the documents is no longer the right one. The duty to give notice of a change of site, composition and formulation should be written into the contract as a separate clause.

Documents are not the last stage A typical failure scenario: first the packaging is approved and a print run of labels is printed, then people go for the documents and find that a different form of conformity assessment is needed and the label lacks mandatory information. The print run goes to the bin. Check the labelling layout before printing.

Budget: what it consists of

It makes no sense to name an exact sum, because it depends on the product. But the structure of costs is the same, and you can use it to check whether a contractor’s offer is reasonable.

Laboratory tests; as a rule this is the main part, and it depends on the number of indicators
Development of the normative document, if you do not work to a standard in force
The work of the certification body, if the form is certification
Analysis of the state of production for some schemes; for a foreign site it includes a visit
The state fee, if state registration is provided for
Translations of the documents of the foreign manufacturer
Design and printing of the marking
A reserve for rework and repeat tests

The last line is the one that is crossed out first and regretted later. Products fail an indicator at the first attempt often enough that you should put this in the plan.

The order in which the steps cannot be swapped

Part of the sequence is rigid, and a breach of the order costs time and money.

Determine the HS code (TN VED) and the list of applicable regulations; everything else depends on this.
Determine the form of conformity assessment: declaration, certificate or state registration.
Fix the name of the product and use it in the same way everywhere.
Determine the normative document for the product.
Bring the product and the production into line with the requirements.
Select representative samples and carry out the tests.
Prepare and check the labelling layout.
Issue the document and register it.
Only now print the packaging run and put the product into circulation.

Steps 7 and 9 are swapped most often: the packaging is printed in advance because the printing house needs time. A compromise: print the main packaging without the mandatory information and put that information on a separate label that can be reissued.

What to check before the first shipment

The document is found in the register by its number, and its status is “valid”
The name in the document matches the label word for word
The manufacturer in the document is the one that actually produced the batch
The EAC mark is applied and legible, and the labelling in Russian is complete
If the products are subject to mandatory labelling, the codes are applied and put into circulation
For a marketplace, proof of the right of sale is prepared if the document is not in your name
The set of documents is kept in one place: at the first request you will need all of it

The typical discrepancies that this check finds are collected in a separate article, and the requirements of the marketplaces are in the article on documents for marketplaces.

Check your product Describe the product in ordinary words. The system will show the expected HS code (TN VED), the applicable regulations and the set of documents. Start the check.