Mexico Manufacturing 2026-04-11 ammex.org.mx editorial team

Medical Device Manufacturing in Mexico Under IMMEX: COFEPRIS Permits, Cleanroom Scrap & Customs

Mexico, led by the Baja California (Tijuana / Mexicali), Chihuahua (Ciudad Juárez), Sonora (Nogales / Hermosillo), and Jalisco / Bajío clusters, is one of the primary global exporters of medical devices to the United States. Operating an ISO 13485 / FDA-registered medical device maquiladora under IMMEX presents a specialized regulatory intersection: your plant must simultaneously satisfy FDA 21 CFR Part 820 (QMSR) lot traceability, COFEPRIS (Mexican Ministry of Health) non-tariff border regulations, and SAT Anexo 24 / Anexo 30 customs inventory accounting.

[!NOTE] Regulatory Scope & Specialist Verification: Sanitary import regulations under the Secretaría de Salud / COFEPRIS Acuerdo depend on the exact 10-digit tariff classification (Fracción Arancelaria + NICO), product formulation, intended use, and customs regime (IN vs. A1). Always verify specific S-series permit keys and XP exemption complements with a licensed Mexican customs broker and regulatory affairs specialist prior to shipping.

When MedTech operations treat Mexican customs compliance like a generic industrial assembly plant, three operational bottlenecks routinely arise: border holds triggered by COFEPRIS non-tariff regulations (RRNAs), unregistered off-site sterilization transfers, and unreconciled cleanroom scrap and consumables.

1. COFEPRIS Non-Tariff Regulations (RRNA) Under Temporary IMMEX Imports

A common misconception among US MedTech operations teams is that because materials are imported temporarily under IMMEX (Clave IN) strictly for export assembly and will never be sold in Mexican hospitals, Mexican health authorities (COFEPRIS) have no jurisdiction at the border.

Under Article 93 and Article 104 of the Mexican Customs Law, temporary IMMEX imports are subject to Non-Tariff Regulations and Restrictions (Regulaciones y Restricciones No Arancelarias - RRNA), including public health and sanitary controls published by the Ministry of Health (Secretaría de Salud), unless the specific Acuerdo de Regulación expressly exempts the temporary import regime for that tariff fraction.

How the COFEPRIS Border Filter Works (`Appendix 9 of Anexo 22`)

Whether a shipment requires a COFEPRIS permit at the border is determined by the 10-digit Mexican tariff code (Fracción Arancelaria + NICO) declared on the pedimento and the Acuerdo de Salud published in the Diario Oficial de la Federación (DOF):

MedTech Material Category	Typical TIGIE Chapters / Headings	Border COFEPRIS RRNA Requirement	Pedimento Appendix 9 / 8 Declaration
Raw Medical-Grade Resins, Extruded Tubing & Metals	Ch. 39 (`3901–3926`), Ch. 72/73 (surgical stainless steel), Ch. 75/81 (nitinol / titanium wire)	Generally Not Listed for COFEPRIS sanitary import permits unless classified as a finished medical device or regulated chemical precursor.	Standard `IN` pedimento; verify chemical precursors do not trigger CICOPLAFEST or dual-use controls.
Active Pharmaceutical Coatings & Biologics (e.g., heparin coatings, antimicrobial agents, collagen sponges, IV solutions)	Ch. 29 (`2936–2941`), Ch. 30 (`3001–3006`), Ch. 38 (`3822`)	COFEPRIS Sanitary Import Permit Required When Listed in the Acuerdo (`Permiso Sanitario Previo de Importación`).	Transmit the VUCEM COFEPRIS e-document and declare the applicable Appendix 9 `S`-series key (such as `S1` or `S2`, depending on the specific Annex of the Acuerdo de Salud) on the pedimento line item.
Unsterilized Semi-Finished Devices & Sub-Assemblies (catheter shafts, surgical blades, orthopedic implants, diagnostic cartridges)	Heading `9018` (Instruments & appliances used in medical, surgical, dental sciences), `9019`, `9021` (Orthopedic appliances, pacemakers, stents)	Subject to Acuerdo de Salud Notes (`Acotaciones`). Depending on the exact fraction, “Únicamente” / “Excepto” scope note, and customs regime (`IN` vs. `A1`), requires either a COFEPRIS sanitary authorization or qualifies for a specific scope/regime exception.	Declare the applicable COFEPRIS authorization (`S1`) or, only where the shipment falls outside the regulated scope or under an express exception of the Acuerdo, declare Identifier `XP` (`Excepción de cumplimiento de RRNA`) with the corresponding complement from Appendix 8 of Anexo 22.

[!WARNING] The “Kit Assembly” Classification Trap: When a US MedTech company ships surgical procedure trays or diagnostic kits to its Tijuana or Juárez IMMEX plant for packaging and sterilization, individual components inside the kit (such as pre-filled saline syringes, topical antiseptics, or sutures under 3006.10) can trigger COFEPRIS prior import permits even if the rest of the plastic tray components are unregulated. Never ship a new BOM component to the border before your Mexican customs broker audits the 10-digit fraction against the current Acuerdo de Salud.

2. Cleanroom Consumables vs. BOM Production Inputs (`Anexo 24` Treatment)

Medical device manufacturing consumes large volumes of specialized cleanroom supplies that are physically required to manufacture the device under ISO 14644 / ISO 13485 standards, but are not physically incorporated into the finished catheter, implant, or IV set:

Tyvek pouches, sterilization indicator strips, and thermoformed blister trays (packaging materials: envases y empaques).
Lint-free cleanroom wipes, nitrile gloves, bouffant caps, IPA (isopropyl alcohol) 70/30 solutions, silicone mold-release sprays, and ultrasonic cleaning solutions (consumables: consumibles).
Microscopic dispensing needles, curing UV lamps, mandrels, and silicone tubing fixtures (tooling and spare parts: herramientas y refacciones).

How to Prevent SCCCyG (`Anexo 30`) Discrepancies on Cleanroom Supplies

If a plant imports lint-free wipes, IPA, and Tyvek sterilization pouches under standard raw material pedimentos (Clave IN) with a VAT credit under its IVA/IEPS Certification, every single unit must be discharged in Anexo 24 and Anexo 30 within the statutory permanence period:

Tyvek Pouches, Blister Trays, and IFUs (Instructions for Use): Must be included directly inside the Anexo 24 Bill of Materials (BOM) of the finished device (e.g., 1 pouch + 1 carton + 1 IFU booklet per finished unit), so every export pedimento (RT) automatically discharges the packaging alongside the device components.
Cleanroom Consumables (Gloves, Wipes, IPA): Because gloves and wipes are not physically attached to the exported medical device, including them in an export BOM invites SAT audit challenges unless they qualify strictly as direct process consumables under Article 108, Fraction I of the Customs Law. Many MedTech controllers prefer to import cleanroom apparel and maintenance chemicals definitively (Clave A1) or source them domestically in Mexico to keep their Anexo 24 and SCCCyG (Anexo 30) ledgers clean for direct BOM materials.
Cleanroom Mandrels, Molds & Fixtures: Must be imported under Clave AF (Fixed Assets) rather than Clave IN, and tracked with serial numbers and physical asset tags on the production floor.

3. Off-Site ETO and Gamma Sterilization (`Submaquila` Under Article 21)

Most medical device IMMEX plants in Mexico perform cleanroom assembly, RF welding, bonding, and Tyvek pouch sealing in-house, and then send the sealed pallets to a specialized third-party Ethylene Oxide (ETO) or Gamma / E-Beam irradiation facility located in Mexico (or across the border in San Diego / El Paso) before final distribution.

If the sterilization facility is located inside Mexico:

Do NOT use a Virtual Pedimento (Clave V1) unless customs custody is permanently transferring to another IMMEX company that will export or further process the goods under its own program.
When the sterilizer is performing a service on your inventory and returning the sterilized pallets back to your plant (or shipping them directly to the US border on your behalf under submaquila rules), you must register the sterilizer as an authorized Submanufacturer (Submaquiladora) on your IMMEX program with the Ministry of Economy via VUCEM under Article 21 of the IMMEX Decree prior to moving any inventory.
Every physical truck movement to and from the sterilizer must carry a CFDI of Transfer (CFDI de Traslado), accompanied by the Complemento Carta Porte whenever the shipment transits federal jurisdiction roadways (or verifying whether a strictly local transit exception under RMF Rules 2.7.7.2.1–2.7.7.2.8 applies), and your compliance team must file the Monthly Submaquila Transfer Notice (Aviso mensual de transferencias para realizar operaciones de submaquila) via VUCEM within the first 5 days of the following calendar month under RGCE Rule 4.3.7 and Ficha de Trámite 71/LA of Anexo 2.

4. Mandatory Customs Discharge of Rejected Medical Devices (`Desperdicios`)

In FDA / ISO 13485 manufacturing, quality control is strict: if a production lot fails leak testing, tensile strength, bioburden, or seal integrity, the batch or individual rejected sub-assemblies must be quarantined and physically rendered unusable so it can never enter medical distribution channels.

From a Mexican customs perspective, quarantining and shredding rejected medical devices in your plant’s scrap room does NOT by itself discharge your customs liability:

Merma vs. Desperdicio:
- Merma: Material consumed or evaporated during the manufacturing process whose physical integration cannot be verified (e.g., evaporated solvents, microscopic laser-ablation dust). Merma is discharged via the BOM consumption factor.
- Desperdicio (Waste / Scrap): Extrusion purge, sprues, runners, cut tubing ends, and rejected sub-assemblies or finished devices that failed QA inspection.
How to Legally Discharge Rejected Medical Devices: While Mexican customs law generally contemplates four discharge mechanisms for desperdicio (return abroad RT, formal destruction DES under Rule 4.3.5, change of regime F4 under Rule 1.6.9, or donation DON under Rule 4.3.4), FDA/ISO 13485 and sanitary restrictions typically prohibit selling or donating defective medical devices locally—leaving two primary operational paths to discharge rejected devices from Anexo 24 and SCCCyG (Anexo 30) before the 18-month temporary import clock expires:
- Physical Return Abroad (Pedimento RT or Scrap Export): Ship the crushed/shredded medical scrap back to the United States (or an authorized foreign recycler) on an export pedimento declaring the original raw material tariff codes integrated into the rejected devices.
- Formal SAT Destruction (Aviso de Destrucción de Desperdicios: Article 109 LA, Article 142 RLA & RGCE Rule 4.3.5 / Ficha 102/LA): File a formal Destruction Notice with SAT in accordance with Ficha de Trámite 102/LA (at least 30 days in advance, or under the applicable procedure for Certified Companies), specifying the date, time, location, material descriptions, weights, and original import pedimentos. After physical destruction in the presence of the authority (or upon expiry of the statutory waiting period if the inspector does not appear), record the Acta de Hechos de Destrucción in Anexo 24 and report it as a valid Destruction Discharge (Descargo por Destrucción) in your SCCCyG (Anexo 30) filing.

Frequently asked questions

Do raw materials imported under IMMEX for medical device assembly require COFEPRIS import permits?

It depends on the 10-digit Mexican tariff classification (fracción arancelaria + NICO), the specific regulatory notes (acotaciones) in the Ministry of Health Acuerdo de Regulación, and Appendix 9 of Anexo 22 (RRNA). Standard medical-grade plastics, stainless steel tubing, and electronic components generally do not trigger COFEPRIS prior import permits unless specifically listed. However, finished or semi-finished medical instruments in Chapter 90, surgical sutures, biological reagents, active pharmaceutical coatings (such as heparin or drug-eluting stent compounds), and pre-packaged sterile components listed in the Acuerdo require either a prior sanitary import permit (Permiso Sanitario Previo de Importación, declared under the applicable S-series key in Appendix 9 of Anexo 22) or an express exemption where permitted by the Acuerdo.

How do MedTech maquiladoras legally send medical devices to third-party ETO or gamma sterilization plants in Mexico?

To transfer assembled medical devices from your cleanroom facility to a third-party Ethylene Oxide (ETO) or Gamma irradiation sterilizer inside Mexico without paying VAT or losing temporary import status, you must register the sterilizer as an authorized Submanufacturer (Submaquiladora) with the Ministry of Economy via VUCEM under Article 21 of the IMMEX Decree prior to moving the goods, document the physical transport with a CFDI de Traslado (incorporating the Complemento Carta Porte whenever the movement uses federal highways or otherwise falls outside the local-transit exception of RMF Rules 2.7.7.2.1–2.7.7.2.8), and file the Monthly Submaquila Transfer Notice (RGCE Rule 4.3.7 and Ficha de Trámite 71/LA of Anexo 2) within the first 5 days of the following month.

Why can't medical device plants simply dispose of rejected catheters, syringes, or cleanroom scrap through standard municipal waste?

Under Article 109 of the Mexican Customs Law, Article 142 of its Regulations (RLA), and RGCE Rules 4.3.3 to 4.3.5, any rejected parts, runners, or defective medical assemblies containing temporarily imported materials (desperdicios) remain under fiscal customs custody until they are legally discharged—typically by physical return abroad (RT) or formal destruction following a prior Destruction Notice (Aviso de Destrucción de Desperdicios, Ficha 102/LA), or in authorized cases via definitive regime change (F4) or donation when sanitary rules permit. Disposing of them without customs discharge constitutes unlawful diversion of temporary imports and invalidates their Anexo 30 VAT discharge.

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