Drugdu.com expert's response:

Pharmaceutical products need to obtain four major types of certifications based on the regulatory requirements of the target markets for export: quality management system certification, regional market access certification, production specification certification, and special product-specific certifications, as detailed below:

I. Quality Management System Certification (Internationally Recognized)

ISO 13485 Certification

Scope of Application: Applicable to all medical device companies exporting products.

Certification Content: An international standard for the quality management system of medical devices, covering the entire process of design, production, installation, and service.

Function: Demonstrates that the enterprise has the capability to consistently produce products that comply with international standards, serving as the "basic threshold" for entering most markets.

Regional Market Access Certification (Select Based on Target Market)

EU Market

CE Certification:

Applicable Products: All medical devices (Class I low-risk products require a Declaration of Conformity, while Classes IIa/IIb/III require a CE certificate).

Regulatory Basis: Must comply with the EU Medical Device Regulation (MDR).

Additional Requirements: For Class IIa and above products, an EU Authorized Representative (EC-REP) must be appointed, and the CE marking must be displayed on the packaging.

Free Sales Certificate (CFS):

Applicable Scenarios: For export to non-EU countries in the Middle East (e.g., Saudi Arabia, UAE) and South America (e.g., Argentina, Colombia).

Function: Proves that the product is legally sold in the EU, meeting the import requirements of the target country.

US Market

FDA Certification:

General Registration: For low-risk products (e.g., Class I medical devices).

510(k) Submission: For medium-risk products (e.g., some Class II medical devices), requiring proof of "substantial equivalence" to a legally marketed device.

PMA Review: For high-risk products (e.g., Class III medical devices), requiring submission of clinical data and evidence of safety and effectiveness.

Factory Inspection Requirements: Enterprises producing high-risk products may be subject to FDA inspections and must comply with quality management system regulations.

Other Markets

Australia TGA Certification: Certification by the Australian Therapeutic Goods Administration, covering medical devices, pharmaceuticals, and biological products.

Russian Registration Certification: Requires registration with the Russian Ministry of Health and compliance with GOST-R technical regulations.

Canada License: Requires obtaining a Medical Device License (MDL) issued by Health Canada.

III. Production Specification Certification (Ensuring Production Compliance)

GMP Certification (Good Manufacturing Practice for Pharmaceutical Products)

Scope of Application: Applicable to pharmaceutical companies exporting products.

Certification Content: Covers all aspects, including personnel, facilities, equipment, materials, production processes, and quality control, to ensure that pharmaceutical production complies with international standards.

Function: Serves as a "mandatory threshold" for pharmaceutical exports; enterprises that fail to obtain GMP certification are unable to obtain export licenses.

Special Product-Specific Certifications (Select Based on Product Type)

Mask Products

EN 14683 Testing: EU standard for medical masks, testing indicators such as Bacterial Filtration Efficiency (BFE) and Particulate Filtration Efficiency (PFE).

Nelson (NELNSON) Testing: Certification by an internationally recognized testing authority, covering core indicators such as BFE, Virus Filtration Efficiency (VFE), and PFE.

Protective Clothing Products

Type 5/6 Certification: EU standards for protective clothing, with Type 5 targeting protection against solid particles and Type 6 targeting protection against liquid splashes.

EN 13795 Testing: Performance testing standards for surgical gowns, including resistance to penetration and tear resistance.

Electronic Medical Devices

EMC Certification: Electromagnetic compatibility certification to ensure that the device operates normally in an electromagnetic environment without interfering with other devices.

Radiation Safety Certification: For radioactive medical devices (e.g., X-ray machines), requires proof that the radiation dose is within safe limits.