GMDN Codes and General Provisions under Article 6.3.1

1. Key takeaways

Of the seven general provisions in Article 6.3.1 of RTS 11.03.02:21, items a to g, three bear most directly on the filing itself. Item b) requires the applicant to submit the GMDN code and terminology corresponding to the device to be registered. Item c) requires the quality, safety and efficacy of the device to be demonstrated by meeting the requirements of the regulation. Item f) sets a registration validity of five years, with renewal due six months before expiry or at the latest within three months after it, failing which the registration is suspended and cancellation proceedings begin. The remaining items cover supplementary information where material is insufficient (d), the continuing validity of documents in the file (e) and the annual fee (g).

The seven items are cumulative, and two of them operate as continuing obligations rather than one-off requirements at submission. That distinction decides how a registration is administered after grant.

• GMDN code and terminology are mandatory, not optional.
• Conformity must be demonstrated, not merely asserted.
• Registration runs for five years, with a defined renewal window.
• Documents in the file must remain valid throughout.
• The annual fee is a separate condition from expiry of the registration.

2. Legal basis

Article 6.3.1 is the general provision on registration, and Chapter 4 supplies the abbreviation used within it. The table records each item and the point it contributes to the file.

3. Expert insights

Insight one: the GMDN entry is a hard requirement, not an option. Article 6.3.1 b) uses the wording shall submit, and the object is the GMDN code and terminology corresponding to the device to be registered. Chapter 4 lists GMDN among the eight abbreviations, which confirms that it is the recognised nomenclature for the purpose. Where a model corresponds to more than one GMDN code, each should be listed in the application rather than a single main code being selected, particularly as the tariff from section 3.1.2 onward is banded by the number of codes and models.

Insight two: the continuing validity in item e) is an obligation that is routinely missed. Article 6.3.1 e) requires the applicant to maintain the validity of the documents submitted in the registration file. A certificate of free sale, a BPM certificate or an ISO 13485 certificate that has expired is therefore a live defect, not something to be repaired at the next renewal, because Article 6.5.1 d) permits inspection without prior notice and an expired document will be found on site. A document register with expiry dates, owned by a named person, is the minimum control.

Insight three: the supplementary information procedure in item d) is normal practice, not a signal of rejection. Article 6.3.1 d) allows the authority to require additional information where the material submitted is insufficient or incomplete. That gives the applicant a predictable rhythm: submit the twelve basic items in full, then strengthen the file item by item in response to the notice. Holding a submission back in pursuit of a single perfect filing usually costs more time than it saves, because the review clock only starts when the file is received.

Insight four: the five-year validity and the annual fee are two independent locks. Article 6.3.1 f) governs validity and the renewal window, while item g) governs the annual fee. Failure to pay the annual fee leads to suspension and cancellation proceedings just as expiry does, irrespective of the remaining validity. Either lock can close the registration, so the two should be tracked as separate calendar events with separate owners rather than as one combined renewal task.

Insight five: item c) is the substantive test, and items d) and e) are what keep it satisfied. The requirement to demonstrate quality, safety and efficacy is not discharged by assembling the twelve basic items of the general dossier; those items are the baseline set, and item c) is the standard against which their content is read. Item d) then provides the mechanism for closing a gap, and item e) prevents the file from decaying once it has been accepted. Read as a sequence, the three items describe a file that is complete, correctable and maintained, and a review team organised around those three questions will usually find the weak points before the authority does.

4. Practical recommendations

• List the GMDN code and terminology for each model individually rather than entering only a main code.
• Maintain a validity register for file documents, and renew certificates of free sale, BPM certificates and ISO 13485 certificates before they expire instead of at renewal.
• Plan on a submit first, strengthen later basis, treating the supplementary procedure in Article 6.3.1 d) as part of the normal process.
• Set the five-year expiry date and the annual fee payment date as two separate reminders, the first six months ahead and the second on an annual cycle.
• Open the renewal window six months before expiry and in no case later than three months after it.
• In the demonstration section of the application, address quality, safety and efficacy separately, as item c) requires each to be shown.

5. Verification checklist

• □ GMDN codes and terminology are listed for every model
• □ A validity register for file documents is in place
• □ A procedure for responding to supplementary information is ready
• □ The five-year expiry and the annual fee are set as two separate reminders
• □ Renewal has been opened six months before expiry
• □ The application addresses quality, safety and efficacy separately

Instruments cited: RTS 11.03.02:21, Dispositivos Médicos. Requisitos para la Regulación Sanitaria de Dispositivos Médicos (Acuerdo No. 14-2022, Diario Oficial No. 156, Tomo No. 436, 2022-08-23), Article 6.3.1 a) to g) and Chapter 4; Tarifario de la Superintendencia de Regulación Sanitaria (2025 edition, SRS website, published 2025-10), Sections 3.1 to 3.4.

Regulatory information verified as at 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Salvadoran market. Our team manages Ministry of Health (MINSAL) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com