Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) has announced the requirements for Good Manufacturing Practice (BPF) certification of overseas manufacturing sites established by Disposición 6403/2026.
The rule applies to manufacturers of medical devices and in vitro diagnostic (IVD) products located outside Argentina that do not fall within the scope of the MERCOSUR inspection arrangements. It clarifies the application documents, the assessment method, certificate validity, recertification and extension of product scope.
1. Key takeaways
1.1 A single framework for BPF certification of overseas manufacturers
ANMAT has approved two annexes that provide a single basis for overseas manufacturers applying for a BPF certificate:
- Anexo I: guidelines for applying for a BPF certificate for manufacturing sites abroad
- Anexo II: the harmonised template for the BPF certificate
Anexo I sets out the application documents and product categories; Anexo II defines the basic format of the final BPF certificate.
1.2 ISO 13485 is a key supporting document
Applicants must submit a currently valid ISO 13485 certificate issued by a certification body accredited by an ILAC or IAF member. The scope of the ISO 13485 certificate must cover the requirements applicable to the products being applied for.
1.3 Not every application leads to an on-site inspection
Once the application is received, INPM (Instituto Nacional de Productos Médicos, the National Institute of Medical Products) first performs a documentary assessment. Depending on the outcome and the risk analysis, ANMAT may proceed in different ways:
| Assessment outcome | Follow-up action |
|---|---|
| Documents meet the requirements | A BPF certificate may be issued |
| Further clarification is required | The applicant is asked to submit additional documents |
| Further verification is required based on the risk analysis | A virtual assessment and/or an on-site inspection is carried out |
ISO 13485 is therefore an important basis for a BPF application, but submitting an ISO 13485 certificate does not in itself guarantee an ANMAT BPF certificate.
2. Application documents
| No. | Document | Requirement |
|---|---|---|
| 1 | BPF application letter | Submitted in the form of a declaration |
| 2 | Applicant company information | Company name, full address, CUIT, Legajo, etc. |
| 3 | Overseas manufacturing site information | Company name and full address |
| 4 | Product category and risk class | State the product categories to be manufactured and the corresponding risk class |
| 5 | Proof of payment of the official fee | Mandatory |
| 6 | Documentation of the importer's authorisation granted by ANMAT | Provided by the Argentine importer |
| 7 | ISO 13485 certificate | Must be the currently valid version |
| 8 | Evidence of the certification body's accreditation | Must show that the certification body belongs to the ILAC/IAF accreditation system |
3. Product categories open to overseas manufacturers
- In vitro diagnostic products
- Active implantable medical devices
- Non-active implantable medical devices
- Dental medical devices
- Ophthalmic and optical medical devices
- Energy-based products for diagnosis and treatment
- Anaesthesia and respiratory products
- Electromechanical medical devices
- Reusable devices
- Single-use devices
- Assistive products for persons with disabilities
- Hospital equipment
The product category and risk class must both be specified in the application.
4. Key timelines and rules
| Item | Rule |
|---|---|
| Initial documentary assessment | 40 working days |
| Timing of a recertification application | A company may apply for recertification before the certificate expires; the application may be filed within 60 administrative working days before expiry. |
| Certificate validity | No single fixed validity period is prescribed; it is determined by the risk analysis and corresponds to the certificates submitted with the application |
| Adding product categories | Holders of an existing BPF certificate may apply to extend the product scope |
| New categories or risk classes | A new application is required |
| On-site or virtual inspection | Decided on the basis of the documentary assessment and the risk analysis |
| Post-certification supervision | Even where a BPF certificate is valid, ANMAT may still carry out routine BPF verifications as provided for in the regulations |
| Pending applications | Cases initiated before the new rule took effect must be handled in accordance with the new requirements and the new template |
5. What this means for medical device companies
ANMAT has now set out clear requirements for the application, assessment, recertification and scope extension of BPF certification for overseas medical device and IVD manufacturers. Companies should focus on their ISO 13485 credentials, product categories and risk classes, the 40-working-day assessment period and the possibility of a virtual or on-site inspection afterwards.