BRAZIL’S LATEST MEDICAL DEVICE REGULATION, ORDINANCE NO.384/2020, WILL BE ENFORCED ON JUNE 28,2021

BRAZIL’S LATEST MEDICAL DEVICE REGULATION, ORDINANCE NO.384/2020, WILL BE ENFORCED ON JUNE 28,2021

RELEASE DATE:2021-03-02 16:30
BriefOn December 18, 2020, in order to prevent accidents, the Brazilian INMETRO (NationalInstitute of Metrology, Standardization and Industrial Quality) issued Ordinance 384/2020 to update the conformity assessment procedures for medical electrical equipment, medical devices will be certified according to the new regulation from June 28, 2021, and Ordinance 54/2016 will be revoke.

EPIDEMIC PREVENTION SUPPLIES Brazil VOLUNTARY CERTIFICATION

REGULATIONS UPDATE
On December 18, 2020, in order to prevent accidents, the Brazilian INMETRO (NationalInstitute of Metrology, Standardization and Industrial Quality) issued Ordinance 384/2020 to update the conformity assessment procedures for medical electrical equipment, medical devices will be certified according to the new regulation from June 28, 2021, and Ordinance 54/2016 will be revoke.
1. Factory audits need to be based on ABNT NBR ISO 14971, ABTN NBR IEC 60601-1, or ABNT NBR ISO 13485, the factory's quality system and risk management system need to be inspected, the production site needs to be evaluated, and product test sightings need to be performed on site.
2. After analyze, test reports that meet the requirement of Ordinance 384/2020 can be accepted
3. The Certificate of Conformity will not expire once maintenance activities are carried out, and the frequency of maintenance audits shall not be greater than fifteen (15) months. If the product design has been changed and the new design needs to be submitted to INMETRO for the record, additional testing may be required.


CERTIFICATION PROCEDURES
1. Factory quality system and risk management system audit (based on ABNT NBR ISO 14971, ABTN NBR IEC 60601-1, or ABNT NBR ISO 13485) 
2. Product testing 
3. Importer system audit
4. Submission of technical documentation 
5. Issuance of certificate (by family) 
6. INMETRO registration 
7. Annual audit for maintenance every 15 months


ABOUT ATIC
We are a young technical service company from China, established in 2015. We have a professional and passionate team, we strive to create the best environment to attract the best experts, returnees and outstanding graduates to join us. We are committed to integrate domestic and international regulations, testing and certification resources with a global perspective in the context of globalization, and establish a new, specialized regulation research, testing and certification platform. We have established authorized or cooperative partnership with governmental departments, authorities, certification bodies and laboratories in more than 30 countries including Germany, Czech Republic, Lithuania, Turkey, United Arab Emirates, South Korea, United States, Brazil, India, Indonesia, Thailand, and Vietnam etc. With our innovative Digital Reporting System (DRS), Customer Service Platform (CSP) and self-developed Global Vehicle Regulation Database (GVRD), our compliance service covers more than 54 countires/regions globally, our testing and certification service covers more than 30 countries/regions worldwide. We serve more than 3,300 manufactures each year.


BRAZIL CERTIFICATION PLEASE CONTACT
kerwin
Expert / Auditor
Kerwin Luo
Graduated from Harbin Institute of Technology, serviced for a well-known domestic OEM. 
Kerwin now is responsible for South America Homologation and Certification business development in ATIC
Phone: +86 17520488951
Email: kerwin.luo@atic-cn.com