Clinical Q&A

Refine = BDDE/MCLPE-crosslinked HA dermal fillers, 20±3 mg/ml, structural correction and volumisation. Revitalize = non-crosslinked biorevitalisers (meso fillers, polynucleotides), skin hydration and regeneration. Enhance = active complex solutions (10×5ml vials) for targeted treatments: lipolysis, hair loss, brightening, post-procedure repair. Each family has distinct indications and injection protocols. Clinics typically stock across all three families.

Sofiderm Deep and Derm Sub-Skin 20ml are formulated for deeper structural placement — cheek volume, jawline, body contouring. Sofiderm Finelines targets superficial dermis: fine lines, perioral, crow’s feet. The Derm and Derm Plus lines cover the middle range — nasolabial folds, marionette lines, lip augmentation.

All Refine products contain 20±3 mg/ml of BDDE-crosslinked hyaluronic acid using MCLPE (Mono-functional Cross-Linking Polymerisation Enhancement) technology. This concentration is consistent across all Refine SKUs, with rheological differences driven by the degree of cross-linking rather than concentration variation.

MCLPE (Mono-functional Cross-Linking Polymerisation Enhancement) is Hangzhou Techderm’s proprietary process. It uses BDDE as the cross-linking agent under conditions that reduce free BDDE residuals and produce a more homogeneous gel matrix. The practical outcome is a gel with controlled G′ modulus and cohesivity. Peer-reviewed references on BDDE/HA cross-linking: PubMed PMID 23330992, PMID 24048099.

BDDE-crosslinked HA forms a persistent gel matrix that maintains structural correction for months. Non-crosslinked HA (Revitalize range) disperses into tissue rapidly, improving hydration, elasticity, and skin quality rather than providing structural lift. The clinical targets are different: crosslinked for correction, non-crosslinked for biorevitalisation.

Sofiderm Derm Sub-Skin 20ml received the Best Injectable Body Filler award at the Aesthetic and Anti-Aging Medicine World Congress (AMWC), Monte Carlo, March 2026. The award was presented by the AMWC scientific committee for clinical relevance and technical innovation in body contouring.

HA derived from bacterial fermentation (non-animal) has a very low allergenicity profile. However, clinicians should take a standard allergy history before treatment. The Revitalize range does not contain animal-derived HA. For patients with documented HA hypersensitivity, consult relevant clinical guidance before use.

Enhance products are not HA fillers. They are active complex solutions: phosphatidylcholine (lipolysis), growth factors, brightening actives, and repair peptides. Supplied as 10×5ml vials. Indications include: localised fat reduction, post-procedure skin repair, hair follicle stimulation, pigmentation management. No structural correction.

CE 2460 is the EU Notified Body number of SGS Belgium NV. Sofiderm products carry CE marking under EU MDR 2017/745 (Medical Device Regulation) as Class III medical devices. The “2460” on the CE mark identifies SGS Belgium NV as the conformity assessment body. This is visible on product labelling and in the Declaration of Conformity.

Yes. All Sofiderm HA fillers are Class III medical devices under Annex VIII Rule 8 of EU MDR 2017/745 (implantable devices). Class III is the highest risk classification, requiring full QMS audit, clinical evaluation, and Notified Body involvement. Orvida holds current Declaration of Conformity documentation for all active SKUs.

Hangzhou Techderm holds ISO 9001:2015 (quality management), ISO 13485 (medical device quality management), and MDSAP (Medical Device Single Audit Program — covering Australia, Brazil, Canada, Japan, and the USA). ISO 13485 specifically governs the design, manufacture, and traceability requirements for medical devices.

INFARMED I.P. is the Portuguese medicines and health products authority. Distributors of Class III medical devices must hold a valid Distributor Notification with INFARMED under Decree-Law 145/2009 and subsequent MDR transposition. Orvida is pursuing INFARMED registration. Until complete, consult our compliance documentation before purchase.

Required at registration: valid medical license (cédula profissional / número de colegiado), clinic or practice address, and acceptance of Orvida Terms and Conditions. For institutional procurement, a purchase order on clinic letterhead may be requested. No additional regulatory documentation is required on the clinic’s side.

Under EU MDR Article 14, economic operators in the supply chain must ensure products they distribute have been legally placed on the market. Purchasing from an unauthorised source breaks the traceability chain required by MDR. Orvida is the exclusive authorised distributor for Portugal and Spain — certificates and documentation are available on request.

MDSAP (Medical Device Single Audit Program) is a single regulatory audit that satisfies the requirements of five national regulators simultaneously. While MDSAP is not mandated in the EU, its presence alongside ISO 13485 signals a higher standard of quality management oversight. It is relevant for clinics with international procurement teams who require multi-market supply assurance.

30G is standard for Sofiderm Finelines in superficial dermis applications (fine lines, perioral). A 27G can be used for higher-viscosity linear threading in mid-dermis. Cannula use is at the practitioner’s discretion; 27G blunt cannula is suitable for sensitive areas.

Sofiderm Deep is suitable for deep dermis to supra-periosteal placement. Strict periosteal injection requires appropriate clinical training and anatomical knowledge of vascular risk zones. Standard aspiration protocol applies at high-risk sites.

Derm Sub-Skin 20ml is formulated for subcutaneous and supraperiosteal placement — deeper than standard dermal fillers. Primary indication: body contouring, buttocks, arms. Not indicated for facial superficial dermis. 25G or 22G cannula preferred for body applications.

Orvida does not prescribe per-site dosing — this is a clinical decision based on individual anatomy, indication, and practitioner training. General consensus guidance: lip augmentation 0.5–1.5ml, nasolabial folds 1–2ml, cheeks 2–4ml per side. Body applications (Sub-Skin): up to 20ml per session per large anatomical zone.

Either is clinically acceptable. Blunt 25G cannula reduces vascular occlusion risk in the nasolabial area. Sharp 27G needle allows precise depot placement. Practitioner training and local anatomy should guide the choice. Both approaches are used with the Refine Derm and Derm Plus lines.

Store at 2–30°C in a dry environment away from direct light. Do not freeze. Once the original packaging is broken, use immediately. All Orvida orders are shipped in temperature-monitored GDP-compliant packaging.

Stop injection immediately. Administer hyaluronidase (bovine or recombinant) without delay — high-dose, multiple-point injection per current consensus guidelines (e.g., British Journal of Dermatology consensus, 2019). Do not massage. Document fully and refer immediately if visual symptoms are present. All practitioners handling HA fillers should have hyaluronidase on site.

Under EU MDR Article 87, serious incidents must be reported to the relevant competent authority: INFARMED in Portugal (+351 21 798 7100, farmacovigilancia@infarmed.pt), AEMPS in Spain (notificaRAM.aemps.es). Orvida’s pharmacovigilance contact is vigilance@orvida.eu.

Sofiderm products have a shelf life of 24–36 months from manufacture date (refer to individual product labelling). Storage: 2–30°C. Do not freeze. Orvida ships with temperature-monitored packaging. Check expiry date before use.

No. HA in Sofiderm products is produced by bacterial fermentation (Streptococcus equi subsp. zooepidemicus) under ISO 13485-controlled conditions. Not animal-sourced. However, as a precaution, clinicians should note the bacterial fermentation origin with patients who have documented gram-positive streptococcal sensitivities.

Common: transient erythema, oedema, bruising at injection site — resolves within 1–14 days. Uncommon: nodule formation (late-onset), hypersensitivity reaction, infection. Rare: vascular occlusion — requires immediate hyaluronidase intervention. All adverse events should be documented and reported per MDR Article 87 where criteria are met.

Late-onset inflammatory granulomas are a recognised rare adverse event with all crosslinked HA fillers. Risk factors: infection, biofilm, product migration. Management: intralesional corticosteroid, hyaluronidase, or combined approach depending on presentation. Reported incidence with high-purity CE-marked HA is low. Reference: PubMed PMID 20969653.

Absolute: active skin infection or inflammation at injection site, known hypersensitivity to HA or gram-positive bacterial proteins, autoimmune conditions affecting skin, pregnancy, breastfeeding. Relative: bleeding disorders, anticoagulant therapy, prior permanent filler in same area, history of severe allergic reactions or anaphylaxis. Clinician judgement required.

Register at orvida.eu/register. Provide your medical license number (cédula / número de colegiado), practice address, and contact details. The Orvida team verifies credentials within 24–48 hours. Once verified, wholesale pricing is unlocked immediately.

Licensed doctors (MD), dentists with aesthetic medicine scope, and registered nurses with prescribing rights in Portugal and Spain. Aesthetic medicine clinics with a licensed clinical director on file. Procurement managers at licensed clinical institutions may purchase on behalf of their practitioners with written authorisation.

There is no minimum order per transaction. You can order a single unit of any SKU. Volume discounts apply at 10+ units (5%), 25+ units (10%), and 50+ units (15%) — mixed SKUs count toward the threshold.

SEPA bank transfer (standard). Credit and debit card payments via Stripe (coming soon — contact us to enquire). Invoices are issued within 24 hours of shipment. Payment terms: 30 days for verified institutional accounts.

All orders are shipped in temperature-monitored packaging maintaining 2–30°C throughout transit. GDP (Good Distribution Practice) compliant. Portugal: 2–3 business days. Spain: 3–5 business days. Tracking number is emailed at dispatch. Signature required on delivery.

Yes. Orvida is the exclusive authorised distributor for both Portugal and Spain. Spanish practitioners register with their número de colegiado. All regulatory documentation (CE, ISO, Declaration of Conformity) is valid across the EU.

Contact orders@orvida.eu within 48 hours of receipt with your order number and description of the issue. For suspected product defects affecting safety, also notify INFARMED (PT) or AEMPS (ES) per MDR Article 87 requirements. Orvida pharmacovigilance contact: vigilance@orvida.eu.