Atuação

A NCC tem como diferencial a competência e experiência técnica em todas as atividades de avaliação da conformidade, considerando os aspectos da qualidade, da segurança e do desempenho de dispositivos Smartworld e equipamentos eletroeletrônicos.

Certificados Emitidos MDSAP

 

 

Nº. Certificado Revisão Validade Descrição Regulamento Status
NCC 21.07037 Rev. 01 17/08/2024 Scope: Manufacture, Import, Export, Distribution, Design, Installation, Technical Assistance, Training and Rental of Electromedical and Medicalhospital devices in the Neurosurgery Area, including their Consumables (sterile and non-sterile) and the Development of Software related to the healthcare area. ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 23/2012; RDC ANVISA nº67/2009 Ativo
NCC 22.09055 Rev. 01 05/01/2025 Scope: Design, development, manufacturing, sales, distribution, installation and technical assistance of dental office, clinical chairs and tables, reflectors and dental X-ray. Distribution of handpieces of high and low rotation, dental electrical, electronics and pneumatic motors, curing light, dental ultrasonic and compressors. ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 23/2012; RDC ANVISA nº67/2009 Ativo
NCC 22.09095 Rev.02 07/02/2025 Scope: “Design, manufacture, technical assistance and distribution of laser hair removal equipment, tattoo removal and depigmentation equipment, laser emitting therapy equipment and fractional CO2 equipment”. ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 23/2012; RDC ANVISA nº67/2009 Ativo
NCC 22.09319 REV.01 24/06/2025 Scope:”Design,development, manufacture, sales and distribution of sterile and disposable instrument kits applicable to otolaryngology,orthopedics surgery and neurosurgery, equipos for ortopedics and sterile surgical electrodes for neurosurgery andortopedics“. ISO 13485:2016 : RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021 ; RDC ANVISA nº67/2009 Ativo
NCC 22.09287 REV.02 17/06/2025 Scope: “Design, development, manufacturing, sales, exportation and distribution of dental products, diamond burs, carbide ISO 13485:2016
Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/ Brasil: RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009
EUA: 21 CFR 820
Japan: MHLW Ministerial Ordinance No.169 (2004) as amended by MHLW Ordinance No. 128 (2014)
Articles 4 to 68; Japan PMD Act (as applicable)
Canada: Medical Device Regulations SOR/98-282, Part 1
Australia: Schedule 3, Part 1 – Full Quality Assurance System; Schedule 3, Part 4 – Production Quality Assurance Procedures
Ativo
NCC 22.09554 REV.02 06/10/2025 Scope: Desing, Development and Production of medical devices for endoscopy, gastronomy and urology. ISO 13485:2016
Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009
Canadá: Medical Devices Regulations – Part 1- SOR 98/282
EUA: 21 CFR 820.20
Ativo
NCC 22.09498 REV.00 13/09/2025 Scope: Design, Development, Manufacture and Distribution of CranioMaxilloFacial Orthopedic Implants, Spine, Extremities (hand and foot), thoracic and Surgical Instruments. Distribution and Technical Assistance of Piezoelectric Motor. ISO 13485:2016
Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009
Ativo
NCC 22.09627 REV.00 04/11/2025 Scope: “Design, Manufacture, Sale and Distribution of Surgical Instruments, External Fixators, Consumable Materials and non-active sterile and non-sterile Implantable Products for: hip, knee and shoulder arthroplasty, craniomaxillofacial osteosynthesis, extremities and traumatology, spine and sports medicine.” ISO 13485:2016
Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº 67/2009
Ativo
NCC 22.09723 REV.00 16/12/2025 Scope: Design, development, manufacturing, distribution, marketing and after-sales support of medical devices, specifically defibrillators/cardioverters and multiparameter monitors. ISO 13485:2016
Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009
Ativo
NCC 23.09766 REV.00 06/01/2026 Scope: Design, Development, Production, and Service of Silicone Gel Filled Breast Implants, Silicone Facial Subcutaneous Implants, Tissue Expander for Single Use, Medical Silicone Gel Sheet, Nostril Retaine. ISO 13485:2016
Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009
Suspenso
NCC 23.09826 REV.00 30/01/2026 Scope: Design, development, manufacture, storage, packaging, shipping and distribution of tattoo ink (artificial pigmentation) ISO 13485:2016
Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009
Ativo
NCC 22.07131 REV.01 11/03/2025 Scope:”Design, development, manufacturing, importing, sales and post-marketing supporting of monitoring and diagnostic medical devices” ISO 13485:2016
Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009
Canadá: Medical Devices Regulations – Part 1- SOR 98/282
EUA : 21 CFR 820.20
Ativo
NCC 22.09740 REV.01 26/12/2025 Scope: Design, development, manufacturing, exportation and distribution of 0.9% Sodium Chloride Pre- filled Syringe ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 Suspenso
NCC 23.09995 REV.01 28/04/2026 Scope: “Design, manufacturing, sales and distribution of medical and dental products: metallic componentes – Dentfix, surgical instruments, no-articulated sharp instruments to micro and mini fragments, no-articulated sharp instruments, Diamond burs – Medicalfix, instruments – Medicalfix, articulated no-sharp instruments – Medicalfix, Diamond ultrasound tips, plate base, surgical kit – Dentfix, metallic components to implants – Dentfix, prosthetic components in polymers, surgical blades – Medicalfix, healer – Dentfix, ultrasound tips with TIN recovering – Medicalfix, polymeric components to implants – Dentfix, dental implants with superficial treatment, orthodontic screws, micro and mini fragments straight plate – Medicalfix, micro and mini fragments screws – Medicalfix, Titanium components – Dentfix, locking rigid fixation system – Medicalfix and Medicalfix 2.4, cranial closure system – Medicalfix, templates – Medicalfix, palatal distractor – Traumafix, micro and mini fragments special plates – Medicalfix.” Not applicable items: 7.5.3 (Installation activities) and 7.5.4 (Servicing activities). ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº 67/2009 Ativo
NCC 23.10044 REV.02 25/05/2026 Scope: “Design, manufacture and distribution of sterile dental implants, sterile and non-sterile prosthetic components and non-sterile surgical instruments” ISO 13485:2016 Austrália: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 Canadá: Medical Devices Regulations – Part 1- SOR 98/282 Japão: MHLW Ministerial Ordinance 169, Article 4 to Article 68 EUA: 21 CFR 820.20 Ativo
NCC 23.10094 REV.00 15/06/2026 Scope: Design, development, manufacturing, sales and distribution of: • Non-sterile implants for osteotomy and traumatology (upper and lower limbs) and cranio-maxillofacial; • Non-sterile reusable surgical instruments for osteotomy, traumatology (upper and lower limbs) support and craniomaxillofacial. • Sterile disposable surgical instruments (ETO) with coated for: craniomaxillofacial, upper and lower limbs coated with diamond and/or DLC, craniomaxillofacial for traumatology, arthroplasty and maxillofacial coated by DLC Black or Diamond; • Sterile surgical instruments (ETO) for surgical support on osteotomy, traumatology (upper and lower limbs) and craniomaxillofacial; • Disposable temporomandibular joint (ETO); • Sterile implants (ETO) with applicator (disposable) with wire andanchor for reconstruction of soft tissue; Sterile implants (ETO) with disposable applicator Button, wire and plate for fixation of fragments on syndesmotic fractures; • Sterile implants (ETO) without disposable applicator with wire and plate for reconstruction of anterior cruciate ligament. ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 Ativo
NCC 23.10153 REV.00 31/07/2026 Scope: “Design and development, manufacturing, exportation, distribution and servicing activities provided by the organization for electromedical equipment as optoelectronic, ultrasonic, radiofrequency or resistive dedicated to medical, aesthetic, helping to diagnosis or therapeutic use” ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 Ativo
NCC 23.10460 REV.00 29/12/2026 Scope: The Quality Management System applies to the design, manufacture, distribution, sales and service of medical devices for cryolipolysis, radio frequency, ultrasound, electromagnetic stimulation and laser equipment. ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 Ativo
NCC 24.10597 REV.00 19/03/2027 Scope: Design, development, manufacturing, after-sales of products for cardiopulmonary use. Import, commercialization and after-sales of products for cardiopulmonary use and implantable neuromodulation devices and servicing of extracorporeal blood treatment equipments for the area of cardiovascular. ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 EUA : 21 CFR 820.20 Ativo
NCC 24.10663 REV.00 17/04/2027 Scope: Design, development, manufacture, sales, distribution, and technical assistance of the following products: – Automatic pressurized pen for mesotherapy, intradermotherapy and drug injection; – Electric pen for microneedling; – High-power focused micro and macro ultrasound equipment; – Microcontrolled laser equipment; – High-power micro and macro focused ultrasound equipment with radiofrequency microneedling; – Laser emission therapy equipment; Import and distribution of sterile health products for mesotherapy, intradermotherapy and microneedling ISO 13485:2016 Brasil: RDC ANVISA nº 665/2022; RDC ANVISA nº 551/2021; RDC ANVISA nº67/2009 Ativo