How to Verify a Peru Registro Sanitario RS Number in the Official DIGEMID Database
Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20
Regulatory information verified as of October 29, 2026.
1. Key takeaways
The credibility of a Peruvian sanitary registration certificate (Certificado de Registro Sanitario, CRS) can only be confirmed through the corresponding sanitary registration (Registro Sanitario, RS) record in the DIGEMID registry; the paper certificate itself is not sufficient evidence. According to statistics derived from the DIGEMID registry, as of 2025-02-14 there were 33,109 registration records, of which 28,819 were valid, involving 6,316 manufacturers, 1,688 registration holders and 68 countries of origin. The gap between total records and valid registrations shows that verification must read the status field, not merely confirm that a number exists. A certificate whose record is cancelled or expired remains findable in the registry, which is exactly why existence alone proves nothing. For importers and distributors, the verification step belongs at the start of the commercial relationship and again before each shipment, because a registration that was valid at contract signing may lapse before the goods arrive.
2. Legal basis
| Regulation | Number | Publication date | Provisions and key points |
|---|---|---|---|
| Reglamento para el Registro, Control y Vigilancia Sanitaria… | D.S. N° 016-2011-SA | 2011-07-27 | Sanitary registration validity of 5 years, counted from the granting date, renewable; Art. 7 (re-registration may be filed 1 year before expiry) |
| Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios | Ley N° 29459 | 2009-11-26 | Capítulo IV (sanitary registration), Capítulo XII (control and sanitary vigilance) |
| Reglamento que establece las Reglas de Clasificación y los Principios Esenciales… | D.S. N° 003-2020-SA | 2020-02-06 | Classification rules and essential principles checklist; referenced when verifying class consistency |
| Listado de dispositivos médicos que pueden ser vendidos al usuario… | R.D. N° 033-2017-DIGEMID-DG-MINSA | 2017-03-12 | List of devices that wholesale distribution companies and laboratories may sell directly to users |
| DIGEMID registry derived statistics | — | Extraction date 2025-02-14 | 33,109 records; 28,819 valid; 6,316 manufacturers; 1,688 holders; 68 countries of origin (Class C data) |
Regulatory information verified as of October 29, 2026.
3. Expert insights
Insight 1: The gap between total records and valid registrations is direct evidence that verification must read the status field.
33,109 records correspond to 28,819 valid registrations, and the difference comes from expired, cancelled and overdue-for-renewal statuses. Mechanically, the registry retains historical records for traceability, not as proof of validity. Verification must therefore land on the status field and the validity field: the existence of a number shows only that a registration once existed; a valid status within the 5-year validity period shows that it is usable now. Comparing numbers against a photograph of a certificate cannot detect the situation in which a cancelled registration is still being used under an old certificate. The registry record, by contrast, carries the status, the validity dates and the holder and manufacturer fields in one view, which is why it is treated as the single authoritative source for verification and why screenshots with dates are archived as evidence of what was checked and when.
Insight 2: The ratio of manufacturers to holders of roughly 3.7 to 1 points to the risk of borrowed certificates.
6,316 manufacturers correspond to 1,688 registration holders, which means most holders represent multiple brands. In this structure, verification must compare two names at once: the registration holder name (Titular del Registro Sanitario) and the manufacturer name. Checking only the holder misses the mismatch in which the certificate of brand A under one holder is used for products of brand B; checking only the manufacturer leaves open the question of whether the trading counterparty is actually entitled to import products under that number. Both checks together are the minimum bar for accepting a supplier, and the same two-name comparison should be repeated at each renewal cycle, because holders and manufacturing sites can change between one registration period and the next without any change in the product itself.
Insight 3: Coverage of 68 countries of origin gives the registry reverse due-diligence value.
Records covering 68 countries of origin make the registry more than a truth-checking tool; it can also be used for supplier due diligence: verifying whether the claimed country of origin matches the registration record, and whether the product has been approved in countries of high sanitary vigilance (such as France, the Netherlands, the United Kingdom, the United States, Canada, Japan, Switzerland, Germany, Spain, Australia, Denmark and Italy, with the list subject to official publication). This step is especially useful when the free sale certificate (CFS) is used together with the list of high-vigilance countries: approval status and origin information corroborate each other, which is more reliable than a single certificate.
4. Practical recommendations
- Run a six-item cross-check: number, status, validity period, holder name, manufacturer name and class; none of the six may be omitted.
- Accept only the registry, not scans: ask the counterparty for the RS number, query the DIGEMID registry directly on your side, archive the screenshot with the query date noted.
- Compute validity from the granting date: validity is 5 years; derive the expiry date from the granting date in the registry record and cross-check the re-registration status.
- Plan re-registration 1 year early: under the Art. 7 window, start one year before expiry to avoid a certificate gap that blocks customs clearance.
- Integrate the registry query into supplier onboarding: complete a full verification before a new supplier is approved, and record the country of origin and the approval status in high-vigilance countries alongside it.
5. Verification checklist
□ Obtained the complete RS number and located the corresponding record in the DIGEMID registry
□ Confirmed that the status field shows valid, not cancelled or expired
□ Computed the validity period (5 years) from the granting date and confirmed it has not lapsed
□ Confirmed that the registration holder name matches the contracting entity
□ Confirmed that the manufacturer name matches the actual place of manufacture
□ Confirmed that the registered class matches the product to be imported, and archived the query screenshot and date
Regulatory information verified as of October 29, 2026.
GRZAN Regulatory Team
GRZAN provides medical device registration support in Peru for manufacturers, importers and authorized representatives. For inquiries, contact info@grzanglobal.com.
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
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