Medical certification became compulsory in 2003.
1. Medical certification Objectives
Medical certification is necessary to certify that appliances meet minimum performance, electrical safety and electromagnetic compatibility requirements, as well as:
- Qualify the products that will be sold;
- Establish rules for the standardization and quality of equipment;
- Ensure that you will not risk the health and safety of the user;
Medical certification is mandatory according to:
- Carrier INMETRO No. 350/2010
- Carrier INMETRO No. 361/2011
- Carrier INMETRO No. 118/2015
- Carrier INMETRO No. 54/2016
3. Key Dates
Carrier INMETRO No. 90 – Technical Commission for Medical.
Carrier INMETRO N º 86 – Replaces NIE-DQUAL-068/2001 – Certification of medical equipment.
Carrier INMETRO No. 350 – Perfects the RAC for electrical equipment under sanitary surveillance.
Carrier INMETRO No. 361 – Approves general product certification requirements.
Carrier INMETRO No. 118 – Optimizes general product certification requirements.
Carrier INMETRO No. 54 – Perfects the RAC for equipment under the health surveillance system.
- 30 April 2017;
Certificates issued until April 30, 2017 may still be issued according to the INMETRO No. 350/2010
- 30 April 2018;
No more licences can be issued according to the INMETRO No. 350/2010
4. Medical equipment that needs certification
The certification of electrical practitioners applies to equipment, including its parts and accessories, for medical, dental, laboratory or physiotherapeutic purposes, used directly or indirectly for diagnosis, treatment, rehabilitation and monitoring In humans, and equipment for the purpose of embellishment and aesthetics.
5. Certification model
The certification of medical practitioners follows only one model of conformity assessment, being:
- Model 5 – Type test, evaluation and approval of the manufacturer’s management systems, and monitoring through the manufacturer’s audits and testing in samples withdrawn in trade;
6. Certification steps
The certification of household appliances is made up of nine steps:
- Initial assessment;
- Certification request;
- Analysis of the request and compliance of the documentation
- risk Management file analysis;
- Initial audit of the quality management system and evaluation of the production process;
- Definition of the test plan;
- Treatment of non-conformity in the initial evaluation stage;
- Issuance of the Certificate of conformity;
- Maintenance assessment.
7. Applicable tests
Medical equipment must undergo operating tests, decided in conjunction with OCP and in accordance with the purpose of the equipment, in addition to the following tests:
- Electromagnetic compatibility (EMC);
8. How long is my certificate valid?
The Certificate of conformity is valid for 5 (five) years, provided that maintenance is carried out every 12 months.
9. Product at the point of sale
Medical equipment may be marketed only if it is clearly and visible to the consumer the conformity identification seal.