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Export compliance

Cosmetic notification accounts across six ASEAN markets

ASEAN has a harmonised Cosmetic Directive, but the six notification systems, account prerequisites and e-signature rules differ enough that one document set will not travel. The one thing they share: none of them lets a foreign company open the account directly — a local legal entity is required.

What a factory can and cannot do here

The account belongs to the brand owner’s local entity. A factory cannot open it and should not imply otherwise. What we do supply is the factory half of the dossier — usually the slowest half to assemble:

  • Full ingredient list and formulation statement, prepared to the destination market’s format
  • Raw-material data for safety assessment: INCI, CAS, supplier CoA, historical use levels
  • Factory credentials: business licence, production licence, GMPC / ISO 22716 documents
  • Support for Certificate of Free Sale applications and product lists
  • Stability, compatibility, microbiological and physicochemical test reports
  • The factory-side content of the Product Information File

Only the local entity can hold these

  • Local company registration and tax number
  • Importer licence
  • Local technical person in charge or licensed pharmacist
  • Hardware USB token (issued only to locally registered companies)
  • Local warehousing and distribution arrangements

The six at a glance

MarketSystemLocal entityHardware e-signatureCore prerequisites
IndonesiaBPOM NotifkosIndonesian PT company requiredNot requiredNIB business registration number (via OSS); NPWP tax number; API-U importer identification number; PJT technical person in charge (chemistry/pharmacy background); Warehouse details
ThailandThai FDA cosmetic notification systemDBD-registered Thai entity requiredDepends on routeDBD company registration — scope must cover cosmetics import/wholesale; System account authorisation letter (official template); Director ID and personal data consent form
MalaysiaNPRA Quest3+Malaysian company required (the CNH)MandatorySSM company registration; LHDN tax registration; Quest3+ USB token issued by MSC TrustGate — bank tokens do not work; System account authorisation letter
VietnamNational Single Window (NSW)Vietnamese registered entity requiredMandatoryVietnamese business registration; Tax registration; Enterprise digital signature from a local CA (shared with tax and customs filings)
PhilippinesFDA e-Notification / eServices PortalPhilippine distributor or importer entity requiredNot requiredSEC company registration; BIR tax registration; System account authorisation letter; Licensed pharmacist credentials — ID, tax card, qualification
SingaporeHSA PRISMACRA-registered Singapore entity requiredNot requiredACRA-registered local company; Designated local responsible person and contact details

Market by market

ID

Indonesia · BPOM Notifkos

BPOM, Indonesian Food and Drug Authority

  • NIB business registration number (via OSS)
  • NPWP tax number
  • API-U importer identification number
  • PJT technical person in charge (chemistry/pharmacy background)
  • Warehouse details

Account set-up here is usually the longest of the six; start early.

Order of steps and official entry points

  1. Set up the local PT and obtain the NIBOSS Online Single Submission ↗
  2. Obtain the NPWP tax numberDirectorate General of Taxes (DJP) ↗
  3. Apply for the API-U importer identification numberOSS (same portal as the NIB) ↗
  4. Appoint and register the PJTBPOM Notifkos ↗
  5. Open the Notifkos account and notify each productBPOM Notifkos ↗
  6. Halal certification — mandatory from 17 Oct 2026BPJPH halal certification agency ↗

Official source ↗

TH

Thailand · Thai FDA cosmetic notification system

Thai FDA

  • DBD company registration — scope must cover cosmetics import/wholesale
  • System account authorisation letter (official template)
  • Director ID and personal data consent form

Keep the authorisation letter short-dated and renew on expiry.

Order of steps and official entry points

  1. Register the Thai company with cosmetics in scopeDepartment of Business Development (DBD) ↗
  2. Tax and VAT registrationThai Revenue Department ↗
  3. Issue the system authorisation letter (official template)Thai FDA Cosmetic Control Group ↗
  4. Open the account and submit each notificationThai FDA cosmetic notification service ↗

Official source ↗

MY

Malaysia · NPRA Quest3+

NPRA, National Pharmaceutical Regulatory Agency

  • SSM company registration
  • LHDN tax registration
  • Quest3+ USB token issued by MSC TrustGate — bank tokens do not work
  • System account authorisation letter

The token carries an annual fee and ships physically; once it expires nothing can be submitted.

Order of steps and official entry points

  1. Register the Malaysian companyCompanies Commission of Malaysia (SSM) ↗
  2. Tax registrationInland Revenue Board (LHDN) ↗
  3. Buy the Quest3+ USB token and install the certificate (bank tokens do not work)MSC TrustGate ↗
  4. Log in to Quest3+ with the token and register as the CNHNPRA Quest3+ ↗
  5. Notify each product and renew before expiryNPRA cosmetic notification guideline ↗

Official source ↗

VN

Vietnam · National Single Window (NSW)

DAV, Drug Administration of Vietnam

  • Vietnamese business registration
  • Tax registration
  • Enterprise digital signature from a local CA (shared with tax and customs filings)

Circular 34/2025/TT-BYT amended cosmetic management and importer duties — this market has moved the most in the past two years.

Order of steps and official entry points

  1. Register the Vietnamese entity and its tax registrationNational Business Registration Portal ↗
  2. Obtain an enterprise digital signature from a local CAVietnam National Public Service Portal ↗
  3. Open the account on the National Single WindowNational Single Window ↗
  4. Submit each notification; every form and attachment must be digitally signedDrug Administration of Vietnam (DAV) ↗

Official source ↗

PH

Philippines · FDA e-Notification / eServices Portal

Philippine FDA

  • SEC company registration
  • BIR tax registration
  • System account authorisation letter
  • Licensed pharmacist credentials — ID, tax card, qualification

The licensed pharmacist is the hard gate here.

Order of steps and official entry points

  1. Register the Philippine companySecurities and Exchange Commission (SEC) ↗
  2. Tax registrationBureau of Internal Revenue (BIR) ↗
  3. Engage a licensed pharmacist and assemble their credentialsPhilippine FDA ↗
  4. Apply for the License to OperateFDA eServices ↗
  5. Notify each product via e-NotificationFDA ePortal ↗

Official source ↗

SG

Singapore · HSA PRISM

HSA, Health Sciences Authority

  • ACRA-registered local company
  • Designated local responsible person and contact details

The lightest of the six, but a named responsible person is still required.

Order of steps and official entry points

  1. Incorporate the Singapore entityACRA ↗
  2. Designate the local responsible personHSA cosmetic notification guidance ↗
  3. Open the PRISM account and notify each productHSA PRISM ↗

Official source ↗

Three things that go wrong most often

An account is not product compliance

The account is only system access. Every product still needs its own formulation, safety assessment and label submission before a notification number is issued, and the PIF stays subject to inspection afterwards.

A narrow authorisation letter has to be reissued

State the full scope: account registration, product notification, dealing with the regulator, handling recalls. Miss one and you re-notarise weeks later.

Changing the local entity costs more than expected

Most of these markets require products under the old account to be withdrawn and re-notified under the new one. Choose the local partner before shipping, not after.

Two scheduling notes

  1. Assess the account and the product on separate tracks. Confirm the local entity is viable first; a perfect formula cannot enter a market whose account never opened.
  2. Pre-review authorisation letters, GMP and CFS documents before issuing them formally. Rounds of corrections cost more time than getting it right once — and they land exactly in the weeks when goods are already in transit.

Need the factory-side document list for a specific market?

Tell us the destination and the product category and we will send the factory documents that market’s notification needs, with our lead time for each.

Start an enquiry

A compilation of public regulatory information, checked line by line against each authority’s own pages, with sources given. Rules and systems change (Vietnam amended its in 2025); the latest official text prevails, and filing is the responsibility of the brand owner and its local representative. BIOSPHERE does not provide overseas registration agency services.