Information Links

Quality Assurance

• Pharmaceutical GMP - PIC/S GMP Guide
  International common good practices adopted by over 40 national regulatory agencies for pharmaceuticals manufacturers.

• Medical Device GMP - ISO13485 Standard
  ISO website which you can purchase the standard for medical device manufacturing

• Good Distribution Practice in Singapore (GDP)
  Medicinal Products, Medical Devices

 

Regulatory

• Singapore - Medical Device
  Health Sciences Authority web site for regulating medical devices in Singapore

• China - Medical Device
  SFDA Regulations on Medical Device (Chinese version)

• Malaysia - Medical Device
  Medical Device web site for proposed medical devices guidelines in Malaysia

• Singapore - Medicinal Products
  Health Sciences Authority web site for regulating medical devices in Singapore

• China - Medicinal Products
  SFDA Regulations on Medical Device (Chinese version)

• Malaysia - Medicinal Products
  BPFK (Drug Control Authority) site for medicine product registration, licencing and monitoring of drug products safety and quality in Malaysia

 

Engineering Services

• International Society for Pharmaceutical Engineering (ISPE)
  World's largest not-for-profit association dedicated to educating and advancing pharmaceutical manufacturing professionals and their industry

Related resources

• FDA
• Eur-Lex
• Health Canada
• TGA
• HSA
• BPFK