The Latin American medical market continues to deliver growth potential. Boasting a stable regulatory framework and expanding medical demand, Peru has become a key destination for Chinese domestic medical device manufacturers expanding overseas. Completing official sanitary registration is the primary critical threshold for products to enter the Peruvian market.
Peru implements risk-based tiered regulation for medical devices, covering four classes from Class I to Class IV with ascending risk levels and increasingly stringent registration requirements.
Class I (Lowest Risk)：Surgical gauze, bandages, general medical masks, surgical gloves, tongue depressors, medical examination beds, etc.
Class II (Low-to-Moderate Risk)：Sphygmomanometers, clinical thermometers, syringes, contact lenses, hearing aids, standard diagnostic ultrasound equipment, disposable surgical gowns, etc.
Class III (High Risk)：Ventilators, dialysis equipment, cardiac catheters, intraocular lenses, vascular stents, anesthesia equipment, extracorporeal circulation devices, etc.
Class IV (Highest Risk)：Cardiac pacemakers, artificial heart valves, implantable defibrillators, artificial joints, deep brain stimulators, drug-eluting stents, etc.
Certificate of Free Sale (CFS)：Issued by the competent official authority of the country of origin. All product models and specifications must be clearly specified on the document. A Spanish translation and Hague Apostille are mandatory for validity.
Instructions for Use and Labelling：Full Spanish versions of product user manuals and outer packaging labels must be provided.
Technical and Test Documentation：Core content including technical file summaries and test report conclusions must be translated into Spanish.
Quality System Certificate：DIGEMID directly recognizes ISO 13485 quality management system certificates, which may be submitted as proof of compliance.
Regulated under the Regulations for Registration, Control and Sanitary Supervision of Medicines, Medical Devices and Medical Equipment, amended by Supreme Decree No. 016-2011-SA, post-registration changes fall into two categories:
Minor Changes：Take automatic effect without official notification from the regulatory authority. The certificate holder must complete all related adjustments within 6 calendar months from the date of notification issuance.Certificate Validity Period: 5 years
Renewal Application Window: Applications may be submitted up to 1 year prior to certificate expiry
Mandatory Renewal Materials: Updated Certificate of Free Sale, updated GMP certificate, payment receipt
