On September 13, 2021, BACL officially obtained the first batch of medical device laboratory accreditation qualifications from the FDA ASCA (Accreditation Scheme for Conformity Assessment) conformity assessment accreditation program of the U.S. Food and Drug Administration!

FDA ASCA conformity assessment program

To ensure that patients can use safe, effective, and high-quality medical equipment in a timely and continuous manner, the US Food and Drug Administration has launched the ASCA (Accreditation Scheme for Conformity Assessment) conformity assessment and accreditation program. The project aims to improve the medical device review process by strengthening confidence in the manufacturer's declaration documents. After application and evaluation, BACL was certified for this program. As an accredited laboratory, BACL is allowed to evaluate medical devices. If a company submits a pre-market notice issued by an accredited laboratory such as BACL following the ASCA process, the FDA will accept the conclusion of the summary report and expedite the review of the submitted inspection report. Approval, thereby improving the efficiency of the FDA’s approval process.

BACL is one of the only 9 laboratories in China listed in the first batch of THE ASCA program approved by FDA.

BACL has long provided comprehensive services for testing, certification, and auditing for the medical device industry. Passing ASCA certification will help your company effectively utilize FDA certification resources, make the pre-market review process more consistent and predictable, and help your products faster and more Efficiently market.

FDA ASCA accredited laboratory listing

BACL’s FDA ASCA accredited laboratory authorization scope includes the following standards:

BACL's FDA ASCA Accredited laboratories are authorized to test the above standards, covering products that:

1. IEC 60601-1-11: Home medical products, such as blood pressure monitors,  air pumps, massage, and health care products etc.;

2. IEC 60601-1-6: Usability evaluation for all medical products;

3. IEC 60601-2-25: Electrocardiograph etc., used to make ECG reports for diagnostic purposes;

4. IEC 60601-2-27: ECG monitoring equipment etc., used to monitor and record the patient's cardiac action potential and display the result data;

5. IEC 60601-2-47: Holter equipment etc., which can continuously record and continuously analyze the ECG;

6. IEC 80601-2-30: non-invasive blood pressure monitor etc.;

7. ISO 80601-2-56: body temperature measuring instrument, forehead thermometer etc..

8. ISO 80601-2-61: oximeter etc.

The official link of BACL's FDA ASCA accredited laboratory authorization is as follows:

https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/asca-accredited-testing-laboratories

FDA ASCA certification process introduction

BACL Service：

BACL is a North American safety certification body accredited by American OSHA & Canada SCC, IECEE CB Scheme NCB and CBTL(CB102, TL730), and EU CAB(Conformity Assessment Body) ( Notified Body No.1313). At the same time BACL is authorized and recognized by A2LA, IAS, CNAS, CMA, FDA, ACMA, SAA etc, and sets its safety testing labs in US, South Korea, Taiwan, Shenzhen Futian & Nanshan, Dongguan, Chengdu, Kunshan.

We can provide you with global certification of IT/AV, HOUS, lighting products, power products, electric tools and other products. Certification service includes US (NRTL, FCC, ENERGY STAR, FDA, DOE, CEC) , Canada(SCC, ISED, NRCan), EU(CE), Korea(KC), EU CE NB, IECEE CB Scheme, Japan (MIC), Singapore (IMDA), Hong Kong (OFCA), Taiwan(NCC, BSMI), Egypt (NTRA, GOEIC), Vietnam (MIC), Saudi Arabia (SASO), Philippines (NTC), Thailand (NBTC), Malaysia (SIRIM), India (BIS/WPC/TEC) and other countries’ certification services, ensuring that your products can enter the international market smoothly under increasingly fierce international trade barriers.