# New Product Introduction Compliance Gate Checklist > Source: https://netray.co/tools/new-product-introduction-compliance-gate-checklist > Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems. > Section: Free Tools ## Short answer A gate review checklist covering market scope, standards, restricted substances, markings, technical file and post-market duties before a product is released. ## Category compliance-legal ## Audience - Compliance engineer - Product manager - Quality manager ## Tool **Kind:** checklist **Groups:** #### Scope and applicability **Items:** **Text:** Target markets and ship-to countries are listed and approved **Critical:** true **Text:** Applicable laws and standards are identified for each market **Critical:** true Product functions such as wireless, battery, software and pressure are recorded Intended use and foreseeable misuse are documented **Text:** Legal manufacturer, importer and authorised representative are named **Critical:** true **Text:** Product is classified for export control and customs tariff **Critical:** true #### Design and testing evidence **Items:** **Text:** Safety, EMC and radio tests are done by a lab with suitable scope **Critical:** true Test reports cover the final design and the exact model variants **Text:** Risk assessment is completed and linked to design controls **Critical:** true Harmonised or recognised standards are listed with edition dates Software and firmware versions under test are recorded Any change since testing has been assessed for impact #### Materials and substances **Items:** BOM is complete down to part level with manufacturer part numbers **Text:** RoHS declarations are held for all components, exemptions listed **Critical:** true **Text:** REACH SVHC screening against the current Candidate List is done **Critical:** true Conflict minerals and PFAS inquiries are sent to suppliers Battery chemistry and transport classification are confirmed Packaging materials are reviewed for restricted substances #### Marking, labelling and documents **Items:** **Text:** Rating plate shows model, ratings, serial or batch and manufacturer address **Critical:** true **Text:** Required marks are applied only where certificates exist **Critical:** true WEEE and battery symbols are on the product where required Country of origin marking is decided and consistent with customs entry **Text:** User manual includes safety instructions in required languages **Critical:** true **Text:** Declaration of conformity is signed by an authorised person **Critical:** true Prop 65 or similar warning need is assessed for California sales #### Records and post-market **Items:** **Text:** Technical file is assembled and stored for the required retention period **Critical:** true Traceability by lot or serial number is set up in the ERP **Text:** Procedure for complaints, incidents and recalls is in place **Critical:** true Market registrations such as WEEE, batteries and packaging are filed Owner and review date are set for certificate renewals Supplier change notification requirements are in the purchase agreements **Scoring Note:** Release should not proceed while any critical item is open. Non-critical gaps need an owner and a date. ## Content **Intro:** Compliance problems found after launch cost far more than those found at design freeze. This checklist is a gate review you can run before releasing a new or changed product to production and shipping. **Sections:** #### How to use the checklist **Body:** Run it at the last design review before production release and again before first shipment to each new market. Tick each item only when evidence exists and is filed, such as a report number, a declaration or a signed form. Critical items are those where a gap normally blocks sale or exposes the company to enforcement. Export the completed list to PDF to keep with the release record. #### Why a gate and not a final inspection **Body:** Most compliance work depends on decisions made early: component choices, enclosure, software and labelling. A gate that links to product lifecycle stages lets compliance veto a release without surprise. Tie the gate to your ERP engineering change process so that a revision to a certified product triggers a re-check automatically. #### Evidence expectations **Body:** Auditors and market surveillance authorities ask to see evidence, not intentions. For each item keep a pointer to a controlled record, such as a document number, a lab report ID and date, or a supplier declaration reference. A declaration signed without supporting test reports and risk assessment is weak and exposes the signatory. #### Common mistakes **Body:** Typical failures are testing a pre-production sample that differs from the released design, applying a mark before the certificate arrives, forgetting importer details on the label, and not planning for substance regulations that change yearly. Another is missing the link between customs classification, country of origin and the product marking, which creates trouble at import. **Cta:** Netray can help connect release gates to ERP change orders so a compliance review is triggered automatically for certified items. **Faq:** #### Who should sign off the gate? **Answer:** At minimum the compliance engineer and the product owner, with quality and engineering review for the evidence. The person who signs the declaration of conformity must have authority and access to the technical file. #### How long must the technical file be kept? **Answer:** It depends on the law. Many EU product laws require ten years after the product is placed on the market, while others differ. Check the retention period in each applicable act and apply the longest. #### Does a small design change need a new gate? **Answer:** Run a short impact assessment on every change. Changes that affect safety, EMC, radio, materials or software of a certified product usually need re-testing or at least a documented technical justification. #### What counts as critical? **Answer:** Items whose absence normally prevents lawful sale, such as missing declarations, uncertified required marks, absent safety instructions or unidentified responsible persons. Adjust the list to your products and risk appetite. ## Search terms npi compliance checklist, product release compliance gate, new product regulatory checklist, product launch compliance review, design review compliance checklist, technical file release checklist, pre-shipment compliance checklist, product compliance gate review template --- Talk to an engineer: https://netray.co/contact?intent=erp_ai | Machine catalog: https://netray.co/agent/catalog.json