Consultation and Training in Medical Devices

Expert in ISO 13485, GDPMD, MDA Regulatory Requirements, CE marking, FDA related and Medical Device Related Requirements

Thursday

PERMOHONAN CE MARKING DAN FDA 51OK UNTUK ALATAN PERANTI PERUBATAN (MEDICAL DEVICE)

 KHIDMAT KONSULTANSI DAN FASILITASI

1. PERSIJILAN ISO 13485

2. EUROPEAN REPRESENTATIVE - CE MARK

3. PRODUCT NOTIFICATION

4. DECLARATION OF CONFORMITY

5. TECHNICAL FILE DEVELOPMENT

6. PENDAFTARAN FDA ESTABLISHMENT

7. APPLIKASI FDA 510K (PENDAFTARAN MEDICAL DEVICE)


INDUSTRI SASARAN:

GLOVE MANUFACTURER, GLOVE TRADING, GLOVE EXPORTER, SYRINGES MANUFACTURER, SYRINGE EXPORTER

Saturday

CONTOH SELESAI PERMOHONAN PINJAMAN TEKUN SECARA ONLINE


PERMOHONAN BANTUAN TEKUN ONLINE

BORANG ONLINE PERMOHONAN PINJAMAN TEKUN NATIONAL

SILA SEDIAKAN DOKUMEN SEPERTI DI BAWAH UNTUK DI UPLOAD:

1. SSM/ LESEN PBT/ LESEN PENJAJA

2. LAMPIRAN PENYATA BANK (SEBULAN SHJ)

3. LAMPIRAN BIL UTILITY

4. LAMPIRAN JPP 02 - SILA KLIK SINI UNTUK MUAT TURUN

5. LAMPIRAN BORANG KEBENARAN PENZAHIRAN MAKLUMAT KREDIT INDIVIDU - SILA KLIK LINK SINI MUAT TURUN

6. LAMPIRAN JPP 25 - UNTUK USAHAWAN TEKUN SEDIA ADA - SILA KLIK SINI UNTUK MUAT TURUN

7. LAMPIRAN KAD PENGENALAN


UNTUK ISI BORANG PDF DI ATAS, SILA KLIK LAMAN WEB INI UNTUK EDIT BORANG
KLIK SINI

NOTA: PASTIKAN ANDA MUAT TURUN DAHULU DOKUMEN PDF KE COMPUTER ANDA SEBELUM EDIT.

DAPATKAN MAKLUMAT LEBIH LANJUT DI SIARAN ZOOM INSKEN BERSAMA PEGAWAI TEKUN DI SINI

Thursday

SIRIM-FRAUNHOFER PROGRAMME (SIIMF FUND)

Technology Audit & SIRIM Industrial Innovation Model Fund



A. Maximum fund value is RM250k  (80% from the fund + 20% company contribution)

- including max ~ RM170k of SIRIM technology intervention on equipment/machinery fabrication.


B. Eligible company (click here) need to be audited prior to fund award (intervention programme).


C. Click link herewith t download the application forms:  http://sirimtechnologyaudit.my




Should you get interested to join the programme, register your company <here>.


SILA KLIK

Monday

MDA HELPDESK LINK

HELPDESK is a medium created by MDA to ease communication regarding various technical matter related to MDA requirement and registration.

Similar to messaging, its create "ticket" as communication password to a dedicated communication matter.

Click link below to enter.

HELPDESK

Sunday

MDA REGISTERED MEDICAL DEVICE LINK


Anda ingin mendaftar barangan perubatan? Rujuk senarai barangan telah didaftar dari link dibawah untuk rujukan:

1. Klasifikasi barangan medikal
2. Rule klasifikasi
3. Senarai produk dan syarikat yang dilantik

Klik di bawah: