Understanding the DIGEMID certification process in Peru

In the food import and export trade, obtaining relevant certifications from the target market is the key to the smooth entry of products into the local market. For food companies that want to enter the Peruvian market, Peruvian DIGEMID certification is essential. Today, let's take a detailed look at the application process for food Peruvian DIGEMID certification.

What is DIGEMID certification?

DIGEMID is the Peruvian Medical Supplies and Drug Administration, which is responsible for supervising the safety and quality of medical supplies, drugs, food and other products in Peru. If food companies want to enter the Peruvian market, they must pass DIGEMID certification to prove that their products comply with Peru's food safety regulations and standards and protect the health and safety of Peruvian consumers. ​

Detailed Process

Product preparation and evaluation

  1. Product compliance review:Companies need to ensure that the formula, production process, labeling, etc. of food products comply with Peru's food safety regulations. For example, Peru has strict regulations on the use of food additives. Companies must confirm that the additives used are within the range permitted by Peru and that the additives are accurately and clearly marked on the label. For example, some food colorings commonly used in China may be restricted in Peru. If you are not careful, it will lead to certification obstacles. ​
  1. Quality Inspection:Select a qualified third-party testing agency in China to conduct a comprehensive test on the product according to Peru's food safety standards. The test items usually cover microbial indicators (such as total colony count, E. coli, Salmonella, etc.), physical and chemical indicators (such as heavy metal content, nutrients, etc.) and additive content. For example, nut foods exported to Peru need to be tested for excessive levels of harmful substances such as aflatoxin. Only products that pass the test are eligible to enter the next certification process. ​

Data preparation

  1. Enterprise qualification documents:Prepare business licenses, production licenses and other documents that can prove the legal operation and production capacity of the company. These documents must be notarized and authenticated to ensure their authenticity and validity. For example, the business license must be notarized by the local notary office and authenticated by the Peruvian Embassy and Consulate in China. ​
  1. Product related information:
  • Product Formula: List the ingredients of the food in detail, including the proportion and source of each ingredient. For example, for a compound fruit juice drink, the proportion of each fruit juice and the origin of the fruit should be clearly stated. ​
  • Production process description: Describe the production process of the product, from raw material procurement, processing and production to packaging and storage. Every link must be clearly explained to show that the company has a standardized production management system. ​
  • Label Sample: Design product labels that comply with Peruvian regulations, including product name, ingredient list, production date, shelf life, storage conditions, consumption methods, country of origin, etc., and must be in Spanish. The label content must be accurate and must not contain information that misleads consumers. ​
  • Third-party test report:Provide the product quality test report mentioned above issued by a qualified testing agency. ​
  • Product Brochure: Introduce the product's features, functions, applicable population and other information, which must also be written in Spanish. ​

Submit your application

  1. Online Registration:Log in to the certification application system of the DIGEMID official website and register a corporate account. Fill in the basic information of the company, such as company name, address, contact information, etc. After successful registration, you will get an application account. ​
  1. Fill out the application form:Log in to the system with your registered account and fill in the food certification application form online. The form needs to accurately fill in the detailed information of the product, such as product category (beverage, snack or condiment, etc.), brand, specifications, etc. ​
  1. Upload data:Upload the prepared enterprise qualification documents, product-related information, etc. to the application system in the format and size required by the system. Make sure that the uploaded information is complete and legible, otherwise it may affect the review progress. ​

Review phase​

  1. Document review:DIGEMID's auditors will conduct a detailed review of the information submitted by the company. Check whether the information is complete and compliant, and whether all information is consistent. For example, check whether the product formula is consistent with the ingredient list on the label, whether the production process can ensure product quality and safety, etc. If any problems are found in the information, they will be fed back to the company through the application system, requiring the company to supplement or modify the information within the specified time. ​
  1. Sample testing (if necessary):Sometimes DIGEMID will ask companies to send product samples for testing. Companies need to send a certain number of samples to Peru according to the address and requirements specified by DIGEMID. After the samples arrive, DIGEMID will arrange for a local laboratory to test the samples according to Peruvian standards. The test content is similar to the test conducted by the company in China, but the test results of the local Peruvian laboratory shall prevail. ​

Get certified

  1. Approved:After document review and sample testing (if any), if the product and information meet Peru's requirements, the company will receive a certification certificate issued by DIGEMID. The certificate will indicate the product name, company name, certification validity period and other information. For example, after a certain brand of chocolate is certified, the certificate will clearly state that the chocolate product has passed the certification and is valid for [specific duration]. ​
  1. Certification follow-up management:Obtaining certification is not a one-time thing for an enterprise. During the validity period of the certification, the enterprise must continue to ensure that the product quality is stable and meets the certification standards. DIGEMID may conduct random inspections of certified products on the market from time to time. If any problems with product quality are found, the enterprise's certification qualification may be suspended or revoked. ​

Processing time and cost

  1. Processing time:The entire certification process usually takes several months. Document review generally takes 1-2 months. If sample testing is involved, it will take longer, possibly 3-6 months or even longer, depending on the complexity of the product and the workload of DIGEMID. For example, some foods with simple ingredients, such as a single variety of dried fruit, may take a relatively short time to process; while for complex foods with complex ingredients, such as health products with multiple functional ingredients, the processing time may be longer. ​
  1. Processing Fees:The fees mainly include application fee, testing fee (if any) and possible agency service fee (if the enterprise entrusts an agency to handle it). The application fee is set by DIGEMID and may vary for different product categories. The testing fee varies according to the test items and the testing agency. Generally speaking, the more and more complex the test items, the higher the fee. The agency service fee depends on the agency's charging standards, usually ranging from thousands to tens of thousands of yuan. ​

Tips for handling

  1. Plan ahead:Since the certification process takes a long time, companies should plan ahead and start the certification application process as early as possible to avoid delays in certification that may result in products being unable to enter the Peruvian market on time. ​
  1. Consult professional organizations:If the enterprise is not familiar with the certification process and requirements, it can consider consulting a professional certification agency or trade consultant. They have rich experience and can provide accurate guidance to the enterprise, help the enterprise prepare materials, improve the success rate of certification, and reduce the time and cost waste caused by improper operation. ​
  1. Pay attention to regulatory changes: Peru's food safety regulations and certification requirements may change over time. During the certification process and after obtaining certification, companies must continue to pay attention to regulatory developments to ensure that their products always meet the latest requirements to maintain the validity of the certification. ​

Although the application process for Peruvian DIGEMID certification of food is relatively complicated, as long as the company understands the requirements clearly and prepares carefully according to the process, it can successfully obtain the certification and open the door to the potential market of Peru. I hope the above content can provide a useful reference for food companies planning to enter the Peruvian market.