Staying on top of industry standards and regulations is no small feat. Regulations – new, updated, or out-of-date – are ever changing. But it’s not optional: making sure you follow relevant regulations even as they’re changing is essential. Keeping up can strengthen your business by improving product safety, ensuring market access, and building trust with your customers.
Knowing the rules and regulations across countries – each with unique sets of compliance requirements – is a huge part of successfully scaling globally. It’s important to have a good understanding of these rules to avoid missteps that can lead to costly recalls, legal battles, and even negatively impact brand reputation.
If the number of rules, regulations, and standards feels overwhelming – you’re not alone. Manufacturers all over the world face this challenge depending on their regions, products, and target markets. Understanding what’s required is the first step to getting it right.
The good news is you don’t have to tackle compliance alone. Here, you’ll find an organized guide to find standards and regulations related to your business.
Geographical regulations
International
- IEC 60335-1: Safety of household and similar electrical appliances.
- IATF 16949: The international standard for automotive quality management systems.
Americas
- CPSC’s regulations and standards: For consumer products sold in the United States.
- FDA's Drug Supply Chain Security Act (DSCSA): Product identification, verification, and tracking of drugs.
Europe
- CE Marking: A mandatory certification mark required for products sold in the EU (health, safety, environmental protection).
- EU Tobacco Products Directive (TPD): Requirements for packaging and tracking tobacco products.
- UKCA Marking: Post-Brexit certification required for product safety.
Asia
- ASEAN Medical Device Directive (AMDD): Standardized medical device regulations.
- China Compulsory Certification (CCC): Mandatory safety certification system requiring certain products be tested and approved by Chinese authorities.
- GB (Guobiao) Standards (China): Product quality & safety regulations. Industry-specific regulations
Industry-specific regulations
Automotive
- IATF 16949: The international standard for automotive quality management systems.
Electronics
- IEC 60335-1: Safety of household and similar electrical appliances.
Medical devices
- ASEAN Medical Device Directive: Standardized medical device regulations.
Pharmaceuticals
- FDA's Drug Supply Chain Security Act (DSCSA): Product identification, verification, and tracking of drugs.
Tobacco
- EU Tobacco Products Directive (TPD): Requirements for packaging and tracking tobacco products.
Barcode symbologies
Another type of global standard many manufacturers have to follow is barcode standards. Read more about symbologies standards.