Skin care
Facial cleansers, moisturisers, masks and body lotions.
ASEAN COSMETICS & PERSONAL CARE
Cosmetic Compliance
Across Southeast Asia
Local cosmetic notification, import support and post-market maintenance in Singapore, Malaysia, Thailand, Vietnam and Indonesia. You develop your brand and sales channels; MediPass puts the local compliance and supply arrangements in place under each country’s requirements.
START WITH THE PRODUCT
Cosmetics cover more than make-up.
Personal care products may fall within the cosmetic framework when their intended use is mainly to clean, perfume, change appearance, correct body odour, protect or maintain external body surfaces, teeth or the oral cavity. Classification depends on intended use, composition, application site and claims.
Hair & scalp care
Shampoos, conditioners, styling products and hair colourants.
Bath & body
Toilet soaps, shower preparations, deodorants and shaving products.
Colour cosmetics
Make-up, lip products and nail cosmetics.
Fragrance
Perfumes, toilet waters and other products intended to perfume the body.
Oral & sun care
Cosmetic toothpastes, mouth-care products and sunscreens, subject to their formula and claims.
“Personal care” or “daily chemical” is not a regulatory classification.
Household detergents, surface disinfectants, insect repellents, ingestible beauty supplements and products with therapeutic claims need a separate scope assessment. Do not assume that a cosmetic notification covers these products.
THE ASEAN FRAMEWORK
Harmonised principles.
Local regulatory responsibility.
The ASEAN Cosmetic Directive (ACD) aligns core cosmetic requirements. Companies must still satisfy the national rules and notify the competent authority in each market where required. An acknowledgement is not a regional safety certification.
Ingredient compliance
Screen prohibited and restricted substances, permitted colourants, preservatives and UV filters against the applicable national annexes.
Labels & claims
Localise required label information and support cosmetic claims with appropriate evidence.
Safety & GMP
Establish product safety and manufacturing quality; check the evidence required in each country.
Accessible PIF
Maintain the product information needed for regulatory inspection and ongoing compliance.
National implementation dates, updates and additional requirements must be checked separately.
COUNTRY-SPECIFIC EXECUTION
Five markets. Five notification pathways.
Select a market to explore the responsible authority, local roles, filing steps and product maintenance requirements.
HSA
Singapore
Local entity and PRISM notification. Annual re-notification; mandatory label information in English.
Explore SingaporeNPRA
Malaysia
A Malaysian Cosmetic Notification Holder submits through QUEST. Notification is generally valid for two years.
Explore MalaysiaTHAI FDA
Thailand
Local manufacturer or importer notification, facility readiness and Thai labelling. Receipt valid for three years.
Explore ThailandMINISTRY OF HEALTH / DAV
Vietnam
Imported products follow the DAV notification process; local responsible business, authorisation and country-specific documents.
Explore VietnamBPOM
Indonesia
Local eligible applicant and BPOM notification. Plan DIP, import requirements and the separate halal workstream.
Explore IndonesiaMEDIPASS
Plan your five-market notification
Tell us your products, formulations, manufacturing country and target markets. MediPass confirms what each market needs, then sets out the notification route and an itemised quotation.
Get a quoteOne ASEAN notification does not cover all five countries.
A shared formulation and PIF can support regional preparation. Each market retains its own notification, local entity, language and post-market requirements.
DOCUMENTATION & SAFETY
Turn product data into a usable PIF.
The Product Information File connects the product formula, quality, safety assessment and evidence for claimed benefits. Preparing a structured master file can make country adaptation more efficient.
01 · Product & administration
Product identity, local roles, formula, labels, authorisation and manufacturing information.
02 · Raw material quality
Ingredient specifications and supporting quality information, including fragrance composition identification where applicable.
03 · Finished product quality
Manufacturing method, specifications, quality controls and relevant stability or microbiological data.
04 · Safety & claimed benefits
Safety assessment, undesirable-effect information and support for the product’s cosmetic claims.
The PIF must be accessible to the responsible local party and authority as required. Indonesia uses the term Dokumen Informasi Produk (DIP); local format and retention rules still apply.
HOW MEDIPASS SUPPORTS YOU
From product assessment to ongoing supply.
LOCAL NOTIFICATION, IMPORT SUPPORT & POST-MARKET MAINTENANCE
No local company of your own.
Connected to your sales channels.
MediPass works with overseas cosmetic manufacturers and brand owners to arrange local product notification, the responsible local party and import support under each country’s requirements, supplies the distributors, retailers and e-commerce channels you appoint, and keeps following up on product-file maintenance, regulatory correspondence and post-market matters.
You develop and manage your sales network; we connect local compliance and import execution.
Scope & market strategy
Review product purpose, claims, manufacturing location and proposed markets to define the regulatory work required.
Formula, label & claim review
Identify ingredient, warning, language and claims gaps before artwork and launch plans are finalised.
PIF preparation & gap review
Organise available manufacturer data and identify missing safety, quality and claim-support evidence.
Local responsibility & notification
Put the notification holder or responsible party in place under each country’s system, with brand authorisation, access to information and ongoing maintenance duties made clear.
Import & supply to appointed channels
Connect filings, shipment documents, applicable import formalities and local delivery, supplying the distribution, retail and e-commerce channels you appoint.
Post-market compliance
Keep following up on the PIF/DIP, notification changes and renewals, regulatory correspondence, safety monitoring and recall coordination.
The notifying party and import model are arranged separately for each country. Specific responsibilities, shipment deliveries, testing and certification, taxes and service fees are set out in the quotation and service agreement.
HOW WE WORK
A clear sequence for regional expansion.
Assess
Map your products, variants, claims and current documentation.
Prepare
Resolve formulation, label, evidence and local-entity gaps.
Notify
Coordinate each national filing and verify market-entry prerequisites.
Maintain
Keep product information, notifications and post-market arrangements current.
COMMON QUESTIONS
Planning a cosmetic launch in ASEAN.
Can we use the same formula and packaging in every market?
A common starting point is useful, but ingredient conditions, national implementation dates, language, local-party details and claims must be checked for each destination. Approve the final market-specific artwork after that review.
Does notification mean the regulator has approved every claim?
No. Notification does not remove the company’s responsibility for safety, quality and claims. In Singapore, HSA expressly states that the acknowledgement is not product approval or endorsement.
What should we provide for an initial assessment?
Send a product list, intended uses, full INCI formulas with concentrations, draft labels and claims, manufacturer details, available GMP and safety evidence, target markets and proposed local partners. We can then identify the scope and missing information.
Can you confirm a fixed launch date at the outset?
A practical schedule follows the readiness review. Document gaps, local-entity setup, testing, legalisation and authority queries can affect timing. Official processing periods should not be treated as a guarantee for the complete market-entry project.
Can we do business through our own chosen channels without a local company?
Yes. Depending on the target country’s system, supply can run through a qualifying local notifier or responsible party and an import arrangement. MediPass can, by agreement, act as the notifier and physical importer in Singapore and as the CNH in Malaysia; in Thailand, Vietnam and Indonesia the qualifying entity and import support are arranged per project. You continue to develop and manage your own sales network.
How are responsibilities split between the manufacturer and MediPass?
You run the brand and channel relationships and provide accurate, complete product and manufacturer information. MediPass takes on the agreed local notification, import support, file maintenance and regulatory correspondence. Import model, title to goods, invoicing, taxes, shipment deliveries and the handover at the end of the engagement are set out in the service agreement.
PLAN YOUR ASEAN MARKET ENTRY & SUPPLY
You build the sales channels.
We connect compliance and supply.
Share your products, formulas, manufacturing country and the sales channels you plan to work with. We will map out local notification, import arrangements and ongoing maintenance against each country’s requirements.